February 2014

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Some Bariatric Patients Face More Lung Problems San Fr rancisco —Patients with metabollic syndrome who undergo bariatriic surgery are more likely to experieence pulmonary complications affter the procedure than are thoose without the syndrome, a new study has found. n In a previous study, researchers from Tufts Medical Center, in Boston, found that roughly 1% of patients undergoing weight loss surgery experience postoperative pulmonary complications,

U.S. RECITE Tells Story Similar to Canadian Study Residual paralysis affects two-thirds of patients in multicenter analysis San Francisco—Most patients who undergo elective laparoscopic and open abdominal surgery experience residual neuromuscular blockade after tracheal extubation, despite the use of neostigmine and neuromuscular monitoring with peripheral nerve stimulation, according to an interim analysis of data from the American arm of the RECITE (Residual Curarization and its Incidence at Tracheal Extubation–US) study.

Previous research has found that residual neuromuscular blockade at tracheal

see bariatric page 34

see RECITE page 32

‘I Broke the Ultimate Taboo’: A Physician’s Downward Spiral Part 1 of 3

I

’ve been practicing for 24 years and was proud of the fact that I always took the tough cases. I was similar to James Garner’s private investigator character in the 1970s television series “The Rockford Files,” in taking on the cases that had been everywhere else. In many instances, I was able to sort things out and make a significant difference for that patient.

That is how I got a number of patients with chronic pain. I did not have specific

training in pain management, but I read lots of articles dealing with chronic pain, including the ones on opioid management. I went to several meetings put on by our state medical board concerning prescribing controlled substances, and I believed I was keeping adequate records.

I thought that would be enough to keep me out of trouble with the board. Little did I know that I was just putting a target on my back. see taboo page 16

07

COMMENTARY

How even a small courtesy between a doctor and his patient can leave a lasting impression.

10

PRN

Anesthesia does a number on the back—yours!

24

POLICY & MANAGEMENT

Clarity on the ‘company model,’ at last.

30

CLINICAL ANESTHESIOLOGY

Watch that trigger finger: Anesthetic spread similar for low,high pressure injections.

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Lesson 308: PreAnesthetic Assessment Of the Pediatric Patient With Pain: Part 1

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April 11-13, 2014

The Cosmopolitan of Las Vegas Topics Featured at the 2014 Advanced Institute for Anesthesia Practice Management As a busy professional you realize it’s imperative to keep informed on the latest topics of interest to Anesthesiologists, Practice Administrators, CRNAs and others in the anesthesia marketplace.

To book your place, please visit

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The Advanced Institute for Anesthesia Practice Management, to be held April 11-13, 2014 at The Cosmopolitan of Las Vegas, offers a chance to experience the following topics, led by industry-renown experts.

What Anesthesiologists Need to Know About ACOs High Reliability Organizing: A New Cultural Model Trends in Anesthesia-Hospital Relations (and Employment) Preparing for ICD-10 Quality’s Impact on the Bottom Line Pain Management Practice Efficiencies Perioperative Surgical Home and other Pathways into the Future Getting the Most out of the Anesthesia Record Mergers are Back Private Equity’s Interest in Anesthesia The AIAPM conference also includes numerous talks on anesthesia and pain billing and coding, charge capture and compliance. Please join us for an informative meeting and exceptional educational experience.

800.242.1131 info@anesthesiallc.com www.anesthesiallc.com

Make An Educated Decision Information You Need To Be Informed and Stay Competitive Anesthesia Business Consultants (ABC) believes the more you know, the better the decisions you can make.

ABC places the highest value on continuing education. As the health care world continues to evolve, offering new technological advances and business models, along with changing laws and regulations, it’s imperative to keep informed. We provide our clients and associates regular updates on what is happening in the world of anesthesiology through our weekly eAlerts. These Alerts highlight the very latest in developments, changing requirements and opportunities and are a complimentary service. If you are interested in receiving these Alerts just send your name, e-mail address, the name of your practice or company, city and state to info@anesthesiallc.com.

ABC is also pleased to offer the Communiqué, our quarterly newsletter, to interested individuals. It is available electronically as well as in print. The Communiqué features articles written by industry leaders focusing on the latest hot topics in group management, compliance and future business models for anesthesiologists, nurse anesthetists, pain management specialists and anesthesia practice administrators.

We look forward to providing you with many more years of practice management news through the Communiqué and our weekly Alerts.

Please log on to ABC’s web site at www.anesthesiallc.com and click on the “Publications” link to view the electronic version of the Communiqué online or to see copies of our previous Alerts.

ABC does not share this list with any third parties nor use it for purposes other than distributing the Alerts, the quarterly Communiqués and the very occasional special announcement. If you have any questions or would like additional information please call 517-787-6440 x 4113, send an email to info@anesthesiallc.com, or visit our website at www.anesthesiallc.com. This communication is for educational informational purposes only and is not intended or offered as legal advice.

4 I AnesthesiologyNews.com

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Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First:

February 2014

The five most-viewed articles last month on AnesthesiologyNews.com 1. Brave New Word 2. Study Probes Anesthesia-Erection Link

This brings to respiratory monitoring what cardiac telemetry brought to cardiac monitoring 30 years ago.

That’s why it’s so exciting.

3. Current Concepts in the Management of the Difficult Airway (Educational Review)

SEE ARTICLE ON PAGE 12.

4. Anesthesia and the Real-Time Mind 5. Consciousness Raising

ACT NOW!

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ROBERT S. LAGASSE, MD, New Haven, CT

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C OR R E SP O NDENCE To the Editor: read with interest the front-page article describing Dr. John Neeld Jr.’s Rovenstine lecture, titled “Winning the War” between the American Society of Anesthesiologists (ASA) an nd the American Association of Nurse Anesthetistss (AANA). He emphasized that these two respectivve professional organizations continue to try to seccure reimbursements selectively for themselves, negllecting the fact that government, hospital, insurance companies and other private interest groups increaasingly are dictating negative terms to all health carre employees in every field.

The anesthesia team allocates resources to provide the highest quality care to all patientss, especially polymorbid patients undergoing inccreasingly complex procedures. Preoperative areas, “surgical homes,” postanesthesia care units and perioperative care outside the operating rooms benefit significantly from this team approach.

Dr. Neeld’s $1 million proposal to examine nursing- versus MD-led care will ultimately fail because it will continue to seek only associations utilizing retrospective analysis by a biased investigator (ASA or AANA). Randomized controlled study of care remains impossible, given the multitude of factors in play.

As this “house divided,” we are facilitating the demise of our profession by allowing the growth of the “fifth branch of government”: nongovernmental bodies positioning themselves to attain increasing incomes and power through regulatory capture.

Dr. Neeld also raised the specter of whether a significantly greater level of education for MDs relative to nurses might not make a difference in care outcomes for patients. There is one simple way to query the importance of this “educational factor” in today’s era of recertification: Why not simply have both nursing and MD boards test the same questions for

comparison would jeopardize board incomes and their exclusive monopolies, should a “universal anesthetist” test prevail.

Although the prospect of finding that nursing education is equivalent to that of MDs and DOs is frightening to the ABA, both the ABA and NBCRNA stand to lose their monopoly share if the world decides to pay any anesthesia provider who can pass a generic examination. More knowledge may be inherent in better care, but any nursing program can, with extra effort and resources, educate to the level of an MD program.

Although Dr. Neeld correctly suggests examining the educational qualifications and abilities of all anesthetists, the redundant existence of multiple, antiquated and expensive board certification and recertification corporations serving primarily to limit the provision of valuable patient care by their licensed diplomates stands squarely today as an impediment to attaining this specific answer.

I

—Paul Kempen, MD, PhD Dr. Kempen is an anesthesiologist in Cleveland.

To the Editor: hank you for publishing Dr. Tania Haddad’s thoughtful letter on noise risks in the operating room [OR] ((Anesthesiology News, December 2013, page 6).

Most ORs will install the capability to play music.

Unfortunately, music that may be relaxing and might enhance patient care mid-procedure is a real distraction during anesthesia induction. Often, youthful staff will play loud rap music and never bother to turn the volume down when the patient enters the OR. A patient recently made comments to me about Michael Jackson tracks playing while I was preparing to administer propofol. Several years ago, the American Society of Anesthesiologists had an initiative against anesthesiologists overdoing their job as “OR DJs.” We would be well advised to show some thought before blasting an iPod during induction.

T

five years for all anesthetists and compare pass rates?

The answer, of course, is that the American Board of Anesthesiology (ABA) and the National Board of Certification and Recertification for Nurse Anesthetists (NBCRNA) won’t allow such a test. These boards prefer to maintain each test for themselves, copyrighted and protected from any external—that is, objective— examination, to maintain respective monopolies and actively avoid comparative measures between different models of care.

The certification industry—read “the boards”— also continues to extort payments from its membership without any evidence-based outcome study or other proof documenting that any benefits from —Sean S. Adams, MD these expensive programs in fact occur. Because certification is a $400 million annual business, this Dr. Adams is an anesthesiologist in Naperville, Ill.

FDA Mandates Text Color Change on Duragesic Patch

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oting in a Drug Safety Communication and Consumer Update that “[the] FDA continues to learn of deaths from accidental exposure to fentanyl patches,” the agency announced it is mandating a color-related change to the text on the Duragesic (fentanyl) transdermal pain patch (Janssen), to allow for it to be read more easily.

Citing reports on the low visibility of current markings on the product, the FDA is mandating the change “to enable patients and caregivers to more easily find patches on patients’ bodies and see patches that have fallen off, which children or pets could accidentally touch or ingest.”

The name of the product and the strength now will appear “in long-lasting ink, in a color that is clearly visible to patients and caregivers.”

The FDA said manufacturers of generic fentanyl patches also will be required to make these changes.

The communication reminded patients and clinicians that the patches are potentially dangerous even after use. Large amounts of opioid analgesic remain in the patches even after they are discarded, and “accidental exposure can result in serious harm and death in children, pets and others,” according to the FDA.

The FDA reiterated that the proper way to dispose of a fentanyl patch is to “fold the patch, sticky sides together, and flush it down the toilet right away.”

The full communication can be found at http:// www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ ucm369457.htm.

Clinicians are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/ report.htm.

—AN Staff

FEBRUARY 2014

AnesthesiologyNews.com I 7

COMMENTA RY

Perfect Stranger

By Stephen Harvey, MD

A

t a recent family gathering, I overheard my father singing to my 9-month-old son. Both of them were laughing, both cooing off key. It was a beautiful and simple moment, and my father appreciated it even more than I did. As he left later that evening, he told me, “See what I would have missed?”

Not many years ago, my father almost died unexpectedly. An active 70-year-old, he developed a headache spontaneously, which intensified over several days. He didn’t tell anyone, however, until it became unbearable.

In fact, he didn’t tell me until he was in the emergency room, being admitted to the neurosurgical unit.

“They say I’ve had a bleed.” He was slurring over the phone. My mother, a registered nurse, served as translator.

She said he had a large right parietal subdural hematoma with an 11-mm midline shift. Surgery was planned for the next morning. “Stephen,” she said, “you need to come home.”

I was a resident at the time, 1,000 miles from my hometown. Things were not going well when I got back to Nashville the next day. My father had had a seizure and was incoherent for 24 hours. My family grieved as our patriarch wandered in and out of delirium. The inevitable postoperative complications did not reassure us.

I stayed for the next few days until I had to return to New York. Back at work, I was wheeling a patient back

Dr. Harvey is assistant professor of anesthesiology at Vanderbilt University, in Nashville, Tenn., where he lives with his wife and two children. His writings have appeared in various medical and literary journals.

to the neuro-ICU when a concerned colleague asked about my father. My patient, Mr. Smith, had just undergone a decompressive craniotomy for a subdural hematoma. Surgery had gone well, and he was resting comfortably.

No one was waiting at his bedside.

The next day I rounded on Mr. Smith.

He was sitting up in bed and looked surprisingly well. We talked briefly about his anesthetic course and outcome.

Then, with complete sincerity, he asked, “How is your father?” I was nearly overcome with emotion. Even through the fog of anesthesia, he had listened to my story and had remembered to ask about my father.

Dad was doing better, I was glad to say. And he still is. Over the next few months, he improved dramatically. I am grateful for his healing, and that he has lived to hold his grandson, even if his singing has not improved.

Mr. Smith recovered, too, and he was discharged home in good condition a few days later. I think about him often, especially when I am around loved ones. I remember him sitting there alone in the ICU, an elderly patient concerned for a young doctor, his spirit generous and discerning enough to ask about someone he never knew.

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Harnessing the Herpes Virus To Precisely Target Pain

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he herpes simplex virus might start getting some good press for a change. Anesthesiology researchers at the University of Miami Miller School of Medicine, in Florida, are using the virus to deliver genetic instructions in the hope of rewriting chronic pain signals at the source.

Spurred by success in animal models and encouraged by results from initial trials in cancer patients, Shaunglin Hao, MD, PhD, Roy C. Levitt, MD, and their colleagues use the virus’s predilection for neurons to their advantage in delivering anti-nociceptive neuromodulating molecules directly to the dorsal root ganglia to treat chronic pain.

Herpes simplex virus (HSV) bears a genome big enough to carry a relatively large “payload” of genetic instructions compared with other vectors, according to the Miami researchers. In addition, HSV remains latent after it enters the neurons of sensory ganglia, a feature that allows gene transfer to continue while evading an immune system reaction, another positive aspect of this approach. Importantly, HSV rendered to prevent replication (“replication-defective”) can still deliver genes during the latency phase exclusively within the sensory nerves targeted.

“We are one of the few centers worldwide working with this innovative technology in preclinical studies,” said Dr. Levitt, director of translational research and

clinical professor of anesthesiology, perioperative medicine and pain management at the institution. “We certainly hope to continue this close collaboration with the inventors and develop new applications and innovative uses of this technology to anesthesiology.”

The inventors are David Fink, MD, of the University of Michigan, Joseph C. Glorioso, PhD, of the University of Pittsburgh, and their colleagues at Periphagen Holdings, a team that pioneered this HSVV mediated gene-transfer strategy. The group has brought HSV vectors into the clinic in Phase I ((Ann Neuroll 2011;70:207-212) and Phase II clinical trials for the treatment of intractable cancer pain.

expressing glutamic acid decarboxylase for neuropathic pain and an HSV vector expressing a neurotrophin for the prevention of neuropathy, he said.

Dr. Levitt said the applications of the approach for clinical medicine “seem almost limitless.” For instance, in anesthesiology, “I can envision an approach where we might treat a patient preoperatively with a nerve block and ‘activate’ the dormant pain treatment just before the surgery to treat acute pain, and possibly post-op to treat and/or avoid chronic pain development in susceptible individuals.

“Only time will tell us the true risk–benefit ratio of this approach as these clinical trials and large-scale patient-use progress and new applications are developed,” Dr. Levitt added. He predicted if the current trajectory of research continues and HSVV mediated gene transfer continues to prove safe and effective, a product launch could come within three to five years.

“This is the frontier of modern medicine and where our specialty will benefit enormously in the future,” Dr. Levitt said. “HSVV mediated gene therapy with localized delivery to sensory nerves important to the care of patients who experience pain will transform our specialty, and as a consequence, change the paradigm of current practice.”

Blocking Pain Signals The trials have assessed the effectiveness of a modified HSV that delivers a gene that encodes for preproenkephalin. Preproenkephalin is a precursor protein that cleaves to produce the endogenous opioid peptides met-enkephalin and leu-enkephalin.

These enkephalin peptides inhibit pain signals in the spinal cord.

Dr. Fink, a neurologist, said his group plans —Damian McNamara another trial with the enkephalin vector. With funding from the National Institutes of Health and from the Department of Veterans Affairs, they are pro- Dr. Levitt reported no relevant financial disclosures. Dr. Fink is a cogressing toward clinical trials of an HSV vector inventor on patents related to this research.

Clopidogrel Increases Bleeding After Robotic CABG

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atients should not take the antiplatelet drug clopidogrel for five days before undergoing robotic coronary artery bypass graft (CABG) procedures, according to researchers at the University of Arizona.

In 2011, the American Heart Association issued a recommendation to hold clopidogrel for five days before traditional CABG, but the organization had not made a similar statement for the robotic procedure. “This study provides food for thought,” said Sophia Vainrub, PharmD, a clinical pharmacist at the University of Arizona, in Tucson, “to justify applying the practice of holding clopidogrel for five daays before CABG to robotic CABG prrocedures as well.” Dr. Vainrub presentted the results of the study at the 2013 American College of Clinical Pharmacy meeting (abstract 91).

“I think the result is interesting, but I don’t think it is surprising,” said Long To, PharmD, a clinical pharmacist at Henry Ford Hospital, in Detroit, who was not involved with this

research. It will provide a good reference for clinicians, who might have questions

Robotic CABG with clopidogrel molecule (inset).

about the increasingly popular robotic procedure, Dr. To said.

The retrospective analysis included 136 patients who underwent robotic CAB; 29% received clopidogrel five days before surgery. Bleeding occurred in a siignificantly higher percentage of patieents who received clopidogrel than paatients who did not (26% vs.

8%, resspectively; P=0.011). Likewise, patientss in the clopidogrel group had ah higher median chest tube outpuut during the 24-hour period after surgery than patients who did not receive the drug (900 vs. 735 mL, respectively; P=0.002). = Allthough it does not involve a sternootomy, robotic CABG still is associatted with bleeding, Dr. To said, particullarly at the targeted vessel and incision n sites.

“Th hese data serve as a good starting point oof investigation into the clinical ramiffications of higher intraoperative bblood loss and higher chest tube ti output in the first 24 hours following

robotic CABG,” Dr. Vainrub said.

“Since those parameters were statistically significantly different in our small patient sample, when applied to a larger patient population, it is possible that they may prove clinically significant,” she said. “However, a larger study would be needed to evaluate this appropriately.”

The choice to hold clopidogrel should be tailored to an individual patient’s needs, Dr. To said. It’s standard practice to hold clopidogrel before traditional CABG, but if a patient has a history of myocardial infarction and is at high risk for reinfarction, clinicians “don’t want to [incur] any risk [they] don’t have to” and they may want the patient to continue to take clopidogrel. The higher odds of bleeding may be preferable compared with increased chances of reinfarction.

—Ben Guarino Drs. To and Vainrub reported no relevant financial conflicts of interest.

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Anesthesiology Can Be a Pain in the Back Survey finds high rate of workplace-related lumbar pain

H

ow does your back feel these days? If you’re in perpetual pain, you’re not alone. Nearly half of anesthesiologists report suffering from low back pain they believe can be traced to the workplace, a new study shows.

Jonathan Anson, MD, of the

Department of Anesthesiology at Penn State University, in Hershey, said he decided to conduct the study after hearing from several members of his department that they’d been missing work because of back pain.

“It got me wondering,” Dr. Anson said.

So he and a few colleagues surveyed all 141 members of the department last summer. Of those, 115 (82%) responded to the survey, which found that 47% of physicians said they had back pain associated with working in the operating room (OR). In that group, 44% said they changed

their workflow to accommodate their discomfort, the researchers reported, including 6.2% who said they’d missed at least one day of work because of the pain.

The survey didn’t get specific details about workflow changes, said Dr. Anson, who presented his group’s findings at the 2013 PostGraduate Assembly in Anesthesiology (abstract P-9110). But he did have a few “best guesses” about the effects.

“First, those with back pain are probably less eager to transport patients around the hospital or from the stretcher to the OR table. They are probably more likely to wait for help and therefore reduce time efficiency,” he said.

“Second, they probably make the conscious decision to bend over less. Therefore, things like checking the Foley catheter for urine output may not be done as frequently as it should. Finally, some providers may alter the way they perform certain procedures,” such as putting in an IV or arterial line or performing tracheal intubation. Some providers may position patients differently to reduce their back pain, or may perform procedures while sitting in chairs, he added.

In general, even among physicians with back pain the level of disability was relatively mild, averaging 4.3 on the 20-point Oswestry Disability Index (ODI). However, 2% of respondents reported having ODI scores above 20, which is considered moderate disability.

Six doctors (5.2%) who responded to the survey reported having had back surgery— which Dr. Anson said was a little surprising given their profession. “Personally, I’m conditioned to think back surgery is a last resort that does not always relieve pain as intended,” he said.

Nearly half of respondents (43%) said they had not received any formal training about workplace-related back pain and how to prevent it.

Younger physicians tended to have higher ODI scores, but the trend wasn’t statistically significant,

FEBRUARY 2014

AnesthesiologyNews.com I 11

PR N according to the researchers. In contrast, those who reported being “burned out” at work did have significantly higher ODI scores (P=0.027).

performed—the OR table, a scanning bed, the ICU or a catheterization lab.

Dr. Anson and his group are now applying to the American Society of Anesthesiologists to bring their Lift With the survey national and make Jonathan Anson, MD Legs … it more detailed. They also Although it’s not clear how are adding information about safe liftanesthesiologists develop back ing and transferring of patients to the pain on the job, one likely annual lectures for incoming residents. source is the lifting and —Adam Marcus moving of patients—particularly those who are overweight or obese, Dr. Anson said.

“The results of this study suggest a deficiency in anesthesia training programs when it comes to teaching proper techniques to prevent musculoskeletal injuries,” the researchers reported.

“To decrease the incidence of back pain in anesthesia providers, it may be necessary to include instruction in proper lifting techniques during residency training and/or routinely incorporate mechanical patient lifting devices in daily anesthesia practice.”

Rich Beers, MD, professor of anesthesiology at SUNY Upstate Medical University, and associate chief of anesthesia at the Veterans Administration Medical Center, in Syracuse, N.Y., said anesthesiologists should heed the new findings.

“The fact that clinicians earlier in their careers had a higher average ODI score is particularly of interest, as those in practice for a while may have developed a system and a process of moving a patient that works for them,” said Dr. Beers, who oversaw the scientific content for the PGA. “Or maybe the physical demands earlier in one’s career are greater. However, I can tell you that our job entails a fair amount of physical work—a lot more than many realize.”

Anesthesiologists often find themselves transporting patients to and from Visit: the OR, or to and from a om remote location, such as cker.c ez-blo a radiology suite. Then there’s the associated transfer of patients from a stretcher to a structure on which the procedure will be

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T E C H NO L O G Y

Every Breath You Take Noninvasive sensor may help clinicians better guide opioid therapy after surgery

A

lower dose of opioids in patients who are moving less air, or a higher dose in those who are in pain but breathing well, yet who traditionally might not receive extra analgesia for fear of respiratory compromise, she said. at Massachusetts General HospiIn a recent study, Christopher tal, in Boston, found that clinicians in Voscopoulos, MD, and his colleagues the PACU were able to use the monitor (ExSpiron, Respiratory Motion Inc.) to demonstrate the effects of opioids on patients’ breathing, and to detect incidents of apnea. The researchers presented the findings at the 2013 PostGraduate Assembly in Anesthesiology, where the poster (R-01) received first prize for work by residents.

The device received initial approval TM in 2012, and the FDA okayed a more streamlined version, with smaller senPlexus Information Systems, Inc. (Plexus IS), a subsidiary of Plexus Management Group, Inc., presents sors, in 2013. So far, a handful of hosAnesthesia Touch , a functionally rich AIMS that offers the most adaptability and scalability in the industry.

Anesthesia Touch is the only AIMS solution to offer direct integration with all EMRs in the U.S.A. pitals, including Mass General and the University of Vermont, are working to Anesthesia Touch gives anesthesia providers the power to manage information electronically from single providers to the largest IDNs on one simple interface from multiple platforms and locations. bring the technology into their postoperative protocols.

Gary John Mullen, MD, MBA, a partner with East Carolina Anesthesia Associates, in Greenville, N.C., said Vidant Medical Center, also in Greenville, recently decided to buy the respiratory monitors for its Level I trauma hospital and all eight of its satellite community hospitals.

“I think it’s still too early to say how [the technology] is currently influencing practice, but I certainly think it’s promising and that it will change practice,” said Dr. Mullen, who has studied the sensor. “This brings to respiratory monitoring what cardiac telemetry brought to cardiac monitoring 30 years ago. That’s why it’s so exciting.”

Vidant will use the sensor in the PACU in high-risk patients, as identified by anesthesiologists. “We think it’s going to speed PACU throughput, reduce respiratory complications in the PACU and on the floor, and reduce respiratory morbidity on the floor,” he Apple iOS and Windows Operates Cloud-based Full Discrete said.

Touchscreen Natively on iPad Solution Data Interface Dr. Mullen said the technology would be “ideal” for detecting patients with residual paralysis after surgery, and thus who are at risk for respiratory complications. “You would immediReal-time AQI and SCOR OR Efficiency Automated ately see patients in the PACU whose Decision Support Preferred Vendor and Utilization Data Capture minute ventilation is below their baseline, and it would immediately send a red flag to the anesthesiologists. We can prevent the complication by putComprehensive Medication ting them on CPAP [continuous posDisease Comorbidity Anesthesia Medication Full EHR Meaningful Simultaneous Capture Reconciliation Use Certified Record Access Safety System with Integrated Single Login itive airway pressure] or by taking novel, noninvasive monitor of respiration for non-intubated patients in the postoperative setting can help clinicians make better decisions about which patients can receive opioids safely after surgery, and which are on the verge of experiencing potentially life-threatening

complications, a new study shows.

“We’ve never before had information from the PACU [postanesthesia care unit] that could allow us to have a course correction,” said Jenny Freeman, MD, a cardiothoracic surgeon, and the inventor of the respiratory volume monitor. Such an adjustment might mean a

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AnesthesiologyNews.com I 13

TE CH N OL OG Y additional precautions before a bad outcome occurs. It’s extraordinary.”

Moving From Subjective Dr. Freeman said she first recognized the need for this kind of monitor as a resident at the University of Alabama, Birmingham, while training in the intensive care unit. “The only thing I had to report was a patient’s workk off breathing; everything else was objectively recorded,” Dr. Freeman said. “We never had a good way to monitor respiration.” Then, she said, in her surgical practice she found that more patients died from postoperative respiratory problems than from cardiac complications. “It has always been disconcerting to me that changes in oxygen saturation occur too late,” she said. “We have never had outcomes data for oxygenation. We needed a better sensor.”

The new monitor uses an electrode strip that measures thoracic impedance, which can be correlated with the volume of air in the lungs. Unfortunately, impedance “had a terribly bad name” for many years, thanks to poorly performing technologies in the 1960s and 1970s, Dr. Freeman said. But she and her colleagues found that recent advances in signal processing and computer algorithms allowed them to build an accurate monitor that noninvasively reports values for minute ventilation (MV), tidal volume and respiratory rate in non-intubated patients.

Dr. Voscopoulos’ data showed that by using a predicted baseline MV based on body surface area, the new system can determine when a patient’s actual breathing falls below 80% of that baseline—suggesting an increased risk for respiratory decompensation.

For patients whose MV falls after surgery, CPAP and opioid reversal agents may be warranted, Dr. Freeman said.

“We now know who to monitor more closely, and we should be able to better manage them clinically,” she said.

In the latest study, the Mass General team used the monitor in 114 patients who had undergone elective orthopedic surgeries, including knee and hip replacements. Approximately twothirds of the patients arrived in the PACU with an MV greater than 80% of baseline and received narcotics without a problem. But when the patients whose MV was below 80% received opioids, it fell even lower, to less than 40% of baseline. “This information may be useful in individualizing pain management protocols with lower opioid dosing or multimodal therapy,” Dr. Freeman explained.

About 23% of patients were said to have postoperative apnea, defined as the occurrence of five or more apneic or hypopneic episodes per hour. Of those, 81% had not been diagnosed with obstructive sleep apnea before surgery.

The researchers also analyzed the risk for opioid-induced respiratory depression (OIRD), defined as an MV below 40% within 30 minutes of receiving narcotics. They found that the vast majority (97%) of patients

with an MV in the safe zone before receiving opioids stayed that way after receiving the drugs. But nearly threefourths of patients (72%) who started in the unsafe zone of below 80% of baseline experienced a drop in MV to below 40%. A diagnosis of sleep apnea before surgery was not a useful indicator for OIRD in the PACU, with a positive predictive value of 0% and a negative predictive value of 69%.

Monitoring MV may be a much better way to identify patients at risk for

respiratory depression than looking at respiratory rate or identifying apneic episodes, Dr. Freeman said. “Noninvasive respiratory volume monitoring gives anesthesiologists a new tool that provides continuous, real-time, quantitative measurements of respiratory status in non-intubated patients. This new data can allow providers to individualize postoperative protocols, maximize patient comfort and improve patient safety.”

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Storytelling Can Revitalize Drug Error Communication Atlanta—Patient safety experts at the University of Texas MD Anderson Cancer Center are transcending old ways of highlighting medication-related error details. Instead of simply issuing recommendations stemming from drugrelated events, they are opting to use homegrown videos to “tell stories.”

Matthew Fricker, RPh, MS, program director at the Institute for Safe

Medication Practices (ISMP), in Horsham, Pa., who is not involved in the project, said narrative-basedd approaches like this are more effective than “telling people we had an error and here are the changes we are making.” Whether the medium used is “video or another approach, telling stories is an excellent way of conveying the gravity of an event,” Mr. Frickerr said.

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Patrick Sayer Monroe, PharmD, a medication safety consultant at MD Anderson Cancer Center, said his hospital decided to go the storytelling route after completing the ISMP’s Medication Safety Selff Assessment for Hospitals in 2011 and finding they “were not doing a good job of communicating details of events on an institutional level.”

December 2013 pg. 1 of 40

Dr. Monroe explained that the center’s “process for sharing details of our events before was a unit-basedd approach.

We relied on unit managers to share details of events with their staff and in our Patient Safety Committee meetings, but the lessons learned were not communicated institutionally.”

Short videos during staff and committee meetings reached more people and the videos could be uploaded to the hospital’s secure intranet site, said Dr. Monroe, who presented his team’s approach at the 2013 University HealthSystem Consortium annual meeting (abstract T37).

The videos are not intended to replace root cause analyses, he noted. Rather, they illustrate gaps in everyday drug use processes that can lead to errors, from prescribing to administration.

Errors that fit this criterion are identified each month by a multidisciplinary team that includes a pharmacist, a nurse and a patient safety specialist. Once they select three events or topics that they believe are good examples of these gaps, another larger multidisciplinary group of pharmacists, nurses and mid-level providers chooses one of the topics to be developed into a visual presentation. “Our communications department helps us create scripts, take photos and record the audio and, if we’re creating a re-enactment, they also help create 700 600 499

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FEBRUARY 2014

AnesthesiologyNews.com I 15

TE CH N OL OG Y

a video component,” Dr. Monroe explained. “All of this is then packaged into a PowerPoint presentation.”

After approval of the video by the hospital’s Institutional Patient Safety Committee, the presentation is posted to the hospital’s intranet site, and hospital leaders are notified that a new video is available.

According to Dr. Monroe, between October 2012 and June 2013, when the approach was piloted, hospital leaders accessed the eight once-monthlyy videos nearly 3,500 times (Figure). Survey questionnaire responses revealed that 83% showed the videos at committee or staff meetings or during “team huddles.” Most hospital leaders considered the video approach a “very” or “extremely” successful way to share medication event information, Dr. Monroe said, adding that the video approach has been adopted permanently as a way of sharing non–drug-relatedd errors as well.

He said front-line pharmacists, physicians and nurses have provided similarly positive questionnaire responses. Ninety percent of respondents said the videos were “somewhat” or “extremely” effective in helping them prevent similar errors.

MD Anderson rolled out another error-prevention initiative around the same time, a pharmacy and nursing shadow program, so the visual reporting program’s effect on outcomes cannot be measured. However, Dr. Monroe

noted that “through voluntary reporting, we’ve found that those errors that we’ve highlighted in the videos have rarely occurred again.” This finding is placed against the backdrop of a trend of increased medication event reporting coinciding with the inception of the video program. He acknowledged, however, that “because reporting is voluntary, there is the possibility that some events

[described in the presentations] are still occurring but not being reported.”

Both Dr. Monroe and the ISMP’s Mr. Frickerr noted that the visual presentation approach is not without its drawbacks. Both experts said there is a risk for the videos finding their way outside of the hospital’s domain. Each video requires between 18 to 24 hours to produce, according to Dr. Monroe. That

amount of time could be prohibitive for some institutions, Mr. Frickerr noted.

“If these resource and security challenges can be overcome, such an approach is highly beneficial,” Mr. Fricker said. “I’ve helped develop videos, and to do them well requires a lot of work.

However, the final product is timeless, and can be used again and again.”

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Reference: 1 4th National Audit Project of the Royal College of Anesthetists and the Difficult Airway Society: Major complications of Airway Management in the United Kingdom. Report and findings: March 2011. Editors: Dr. Tim Cook, Dr. Nick Woodall, and Dr. Chris Frerk.

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TABOO

CONTINUED FROM PAGE 1

Increasing Vulnerability Meanwhile, other problems were building. I always had taken my time with patients. This was great for the patients, but that meant my income was always on the low side. I compensated for this by being a workaholic with both long office hours and a hospital practice. This left very little time for my family. My wife accepted this situation as part of being a doctor’s wife, but we grew more distant. Our love life was virtually nonexistent. I had a serious illness in 2009 and missed two months of work. That really caused financial problems, and we had virtually no money to enjoy even simple things like dining out or a movie. That serious illness brought us much closer together, but our bedroom life never improved. I spent more time flirting with the nurses, and became increasingly vulnerable. That’s not an excuse, just simply a fact.

I had been treating pain patients for many years.

Many of them had been titrated gradually up to fairly high opioid doses. I even accepted referrals from other physicians unwilling to prescribe opioids.

The result was that I became one of the largest local opioid prescribers. I stood out even more because of other doctors who were unwilling to treat pain patients. We had a local pain management clinic that was relatively expensive and was primarily procedureoriented. It was not an option for patients without insurance. I also had some patients who had failed pain management procedures, and the only alternative was opioids.

I saw some good results with regard to improving patient function, and the patients were very grateful. However, I was too lenient and generous with my prescribing. Many of these patients I had known for years and completely trusted. I thought I could always identify the addicts and abusers. I dismissed a few patients when their behavior stood out (e.g., calling for early refills). I was investigated once for dismissing a patient after I confirmed a tip that she had sold her prescription. I didn’t do a lot of drug testing because

it was very expensive for uninsured patients. I tested mostly for cause and not routinely.

Our state had just started a prescription drug monitoring program that I used occasionally to check on patients, but not enough to suit the board. They didn’t have any written guidelines for what monitoring was required for pain management patients, just a nebulous “standard of care.” I had not been attending pain management meetings where they stressed the current standards for monitoring patients. The country was in the middle of an explosion of prescription drug abuse, and the board was determined to take action against prescribers.

‘Out To Get My License’ I was visited by an investigator from the board, who brought with him a subpoena for the records of 16 patients. He assured me that was routine, and said if no problems were found I would not even have to go to a board meeting. Some of these patients had multiple charts, and it took me several weeks to get them copied and submitted. I breathed a slight sigh of relief when I saw the list, since all were long-term patients, and I thought I would not have any problems justifying their treatments.

The investigator came back several weeks later with a subpoena for several additional charts; this was more troubling, since I knew these were going to be problematic. One was a patient for whom I had replaced a prescription. She had come to me with a story that her prescription had been essentially extorted by someone else. The “someone else” was known to be violent, and I still believed that my patient had a legitimate need for back pain medicine.

I had given her a second prescription. The pharmacist had questioned it at the time. She even asked me to fax a note justifying the replacement.

The second chart was a patient I will refer to as JC. He had daily headaches, chronic anxiety and panic attacks. He was a smoker and had a difficult family situation. He was a patient who always had been difficult to treat, and required higher than standard

doses of medication. I had admitted him to the hospital about four years before with intractable migraines and vomiting. Both gastrointestinal medicine and neurology had seen him in consultation, but had not been very effective in controlling his problems. I finally was able to control his symptoms and get him out of the hospital by using daily doses of lorazepam and opioids.

Two years ago, JC slipped and suffered a compression fracture of his lumbar spine. He had continued to have chronic back pain that pushed his daily opioid dosage even higher. I knew my treatment of him, which included multiple opioids, would be considered controversial and difficult to justify.

I also knew he had been working undercover making drug buys. During his monthly visits, he would relate some of the details of his undercover work. He truly hated drug abuse and abusers, and that was why he volunteered to work undercover for several local sheriffs’ departments. He had a twin brother who had neck pain from a pistol bullet lodged in his neck against a vertebra, whom I began treating. His story was confirmed easily by an xx rayy and seemed to justify medication. After JC found out I had been treating his brother for a few months, he told me his sibling was abusing his pain medicine. I dismissed the brother shortly afterward following an irregular drug test result.

After a couple of months, I was notified in a letter that I had a hearing with the board of medical examiners. I had talked to another physician who had dealings with the board, who told me I needed to contact my malpractice carrier immediately since they would cover the cost of an attorney to represent me in licensure matters. I had no idea that this was a standard feature of malpractice coverage. They promptly assigned an attorney who had an excellent record, but most of his experience was with malpractice cases rather than licensure issues. I’m not criticizing him, however, because my case clearly had some problems, specifically with some of the prescriptions I had written. To make matters worse, the investigator showed

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AnesthesiologyNews.com I 17

PA IN M E D ICIN E me I was the highest local prescriber for some of the more commonly abused pain medicines. He was a former narcotics cop, and was convinced I was a bad he FDA has allowed marketing of the Cerena doctor. He was clearly out to get my license.

Transcranial Magnetic Stimulator (TMS; eNeura I’m sure the board was under pressure to control Therapeutics), the first device to relieve pain caused the epidemic of prescription drug abuse. I had put by migraine headaches that are preceded by aura in myself in harm’s way by being entirely too lenient in people aged 18 years and older. my prescribing. At the time, there was some debate “Millions of people suffer from migraines, and about how to deal with breakthrough pain in chronic this new device represents a new treatment option pain patients. I had read articles dealing with breakfor some patients,” said Christy Foreman, director of through pain, and didn’t find any set guidelines or the Office of Device Evaluation in the FDA’s Center recommendations on how to proceed. I had been for Devices and Radiological Health. allowing my patients four-times-dailyy doses of medThe Cerena TMS is a prescription device used ications for breakthrough pain in addition to their after the onset of migraine pain. Using both hands long-actingg opioids. That came in part from my to hold the device against the back of the head, the experience with cancer patients, in whom addiction user presses a button to release a pulse of magnetic was not a concern. That is why my prescribing habits energy to stimulate the occipital cortex in the brain, stood out so much. I now know that excessive breakwhich may stop or lessen the pain associated with through medicines just push up tolerance and are not migraine headaches preceded by aura. recommended for chronic pain patients.

The FDA reviewed the data for the Cerena TMS The investigator spent a lot of time trying to find through the de novo o premarket review pathway, a other evidence of misconduct, such as splitting preregulatory pathway for some low- to moderate-risk scriptions with patients, or trading sex for prescripmedical devices that are not substantially equivalent tions. I never had done any of those things. I was to an already legally marketed device. only titrating medication I thought was appropriate The FDA reviewed a randomized controlled clinifor my patients’ pain problems. The female patient cal trial of 201 patients who had mostly moderate for whom I had replaced the prescription (for which to strong migraine headaches and who had auras I had been reported by the pharmacist) was asked preceding at least 30% of their migraines. Of the repeatedly whether I was trading sex for prescriptions. study participants, 113 recorded treating a migraine Apparently those behaviors are very common with bad doctors. The investigator never found any evidence of that, and never even asked for a urine drug test. I offered to take one but was told he would collect it some other time. than me and attractive. She referred to herself as a “trophy wife.”

The ‘Trophy Wife’ The second winter I was treating DeeDee, she had Six or seven years earlier I had had a single, very a bad respiratory infection, and I called in prescripdiscreet affair. My wife had made the statement pre- tions for antibiotics and cough medicine. Her case viously that if I had an affair, she did not want to was touch and go for several days as to whether she know about it. We were getting counseling together would need admission to the hospital. I was able to for the marriage, and she was getting individual text—not talk—her through that illness, and we counseling for her sexual dysfunction, which was developed a friendship. We started chatting back and diagnosed as vaginismus. After several years of coun- forth via texting. We discovered we had quite a few seling with very little visible progress, I was definitely things in common. We were both ardent football open to another affair. I made a few online contacts, fans, and relatively lonely in our personal lives. but none wanted to have an affair with someone who Texting has become an almost indispensable form was married. Trying to date in a small town was obvi- of communication for many of us. I had a number ously out of the question. I had a vehicle that was eas- of patients with whom I had developed friendships, ily recognizable. But I did not want to be doomed to and we would text back and forth at times. Somecelibacy. times I would text them while watching television Along came someon ne I will call in the evenin ngs. Texting, however, DeeDee. It started innocently also represeents a new pathway enough. She was a patient I into an “inappropriate” relahad been treating forr approxitionship. You can do it even mately 18 months foor sevif your sspouse is in the room. eral problems, including That m makes it easy to commigraine headaches. She mun icate without the also was involved in a car intruusiveness and possible accident and suffereed quesstions that a phone whiplash. In the coonversation would course of her roueentail. Unless your tine visits, she told spouse is actually me she was part cchecking your phone, owner of a business, ttexting is relatively and was divorced. secret. Even if she She was more than gets the cell phone 20 years younger bill, most plans

FDA Permits Marketing of Device To Relieve Migraine Pain

T

at least once when pain was present. The study showed that nearly 38% of participants who used the Cerena TMS when they had migraine pain were pain-free two hours after using the device compared with about 17% of patients in the control group.

After 24 hours, nearly 34% of the Cerena TMS users were pain-free compared with 10% of the control group.

The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light and sound and nausea. It also did not evaluate the device’s performance when treating other types of headaches.

Adverse events reported during the study were rare for both the device and the control groups, but included reports of sinusitis, aphasia and vertigo. Dizziness may be associated with the use of the device.

Patients must not use the Cerena TMS device if they have metals in the head, neck or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures.

The recommended daily usage of the device is not to exceed one treatment in 24 hours.

—Based on a press release from the FDA

provide unlimited texting, and do not list the actual numbers to which you are sending messages. If you delete the texts, the only record is with the phone company; and in most cases, this is just the numbers sending and receiving messages. If you send a lot of text messages, then a few more look innocuous. You begin to believe you can get away with things that might have consequences if discovered. This is a new kind of trap, one you won’t see coming.

Over the next few months, I continued to text DeeDee. She started telling me more and more about her personal life. She was divorced from her second husband, and they had been separated for nearly two years. She previously lived in Washington, D.C., for more than a year. She actually dated a doctor there, but apparently the relationship soured and she returned to this area. He apparently still had family here and had recently returned to work at a local hospital. She had tried to end the relationship, but he kept showing up at her house, and could have been considered a stalker. She never would tell me his name, and to this day I don’t know how much of this really happened.

Late one night, the texting was about sexual topics. She asked me if I had ever cheated. After I admitted that this had happened once before, DeeDee suggested we get together. She was very graphic in what she would like to do with me. I told her I would think about it. After all, I had known her for almost two years. Since she had a business, she too had a lot to lose. I thought I could trust her in a discreet relationship. Little did I know how much trouble that decision would bring.

—Name Withheld

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Surgery May Benefit Patients With Even Mild Cervical Spondylotic Myelopathy

S

surgery improves symptoms of cervical spondylotic myelopathy (CSM), even when the disease is mild, a recent study suggests.

Surgeons from 12 hospitals in the United States and Canada prospectively studied the outcomes of 260 men and women who underwent surgical decompression for CSM, and found most individuals with mild, moderate or severe disease improved significantly. There was an 18.7% complication rate.

Michael Fehlings, MD, PhD, who led the study, which was published in the Journal of Bone and Joint Surgery (2013;95:1651-1658), said that despite the lack of a nonsurgery control group, the findings are valid.

“The view in the clinical community is that even though the evidence supporting surgery for mild myelopathy is somewhat equivocal, the current standard is surgery. So it’s not considered ethical not to do surgery, and that’s why we didn’t have a control group,”

and the 110 with moderate disease were significantly younger than the 83 with severe CSM. They also had higher preoperative scores on the 36-item Short Form Health Survey (SF-36) and lower scores on the Neck Disability Index and the Nurick scale.

One year after surgery, the patients experienced a said Dr. Fehlings, medical director of the Krembil statistically significant improvement in most of the Neuroscience Centre at Toronto Western Hospital, in characteristics the investigators examined, including Ontario, Canada. “And our study showed that even nine of the 10 health-related quality-off life param[patients with mild CSM] can have significant disabil- eters examined by the SF-36. The investigators also ity and pain, and they can benefit from surgery.” found that the degree of improvement was not predBut in an accompanying commentary, orthope- icated on the severity of symptoms before surgery dic surgeon Ronald Lindsey, MD, of the University except in the case of the modified Japanese Orthoof Texas Medical Branch, in Galveston, said the lack paedic Association scale, for which improvement was of a control group is “regrettable” (J ( Bone Join Surg associated with higher preoperative scores.

2013;95:e1381-e1382).

“Most complications were minor and not func“This is particularly relevant for the issue being tionally significant. The rate of permanent neurostudied because patients with symptomatic CSM can logic dysfunction as a complication was under 1%,” stabilize with nonoperative treatment,” Dr. Lindsey Dr. Fehlings said. wrote. “[However,] this paper clearly demonstrates The study was funded by AOSpine North Amerthat surgery can offer functional, disability-related ica, Inc., a nonprofit corporation that advocates for and quality-off life improvements at 12 months com- the interests of spine surgeons. pared with the preoperative baseline for patients with —Rosemary Frei, MSc symptomatic CSM.” The 85 individuals in the study with mild CSM Drs. Fehlings and Lindsey reported no relevant conflicts of interest.

Decline in Rates of Joint Surgery Seen Reflecting Better Disease Control San Diego—Rates of orthopedic surgery are declining among patients with rheumatoid arthritis (RA), at the same time that aggressive therapy with biologics is on the rise. Authors of a large, long-term ongoing study believe that the reduced need for surgery is a direct result of aggressive therapy with newer agents, although this was not proven in the study.

“We conducted the study to determine whether the incidence of orthopedic surgery is declining over time in patients with RA and whether patientreported outcomes predict the need for such procedures in the future. Our study suggests that the rate of orthopedic surgery was reduced by early intensive treatment in patients with severe RA,” said lead author Korosh Hekmat, MD, of Lund University, in Sweden.

Although the study was conducted in Sweden, Dr. Hekmat said several studies in the United States have shown similar declines in rates of joint surgery.

The study, which was presented at the 2013 annual meeting of the American College of Rheumatology (abstract 2682), was based on 2,342 men and women from RA registries in Sweden who answered questionnaires that included visual analog scales for general health and pain, and the Health

Assessment Questionnaire (HAQ), a measure of disability, in 1997, 2002, 2005 and 2009. Response rates ranged from 62% to 74%, depending on the questionnaire. Responses to the questionnaire were linked to the Swedish national health registry to correlate the data with records of inpatient and outpatient surgery, as well as use of biologic drugs. The rate of orthopedic surgeries was calculated for three time periods: 1998-2001, 2002-2006 and 2007-2011.

For the overall study period of 1998-2011, the rate of any orthopedic surgery was 82.3 per 1,000 patient-years.

However, significant declines in the rate of any orthopedic surgery were seen from 1998 to 2011. In the first period, the rate was 94.6 per 1,000 patientyears, declining to 82.6 per 1,000 patient-years in the second period, and falling to 71.8 per 1,000 patient-years in the third period (P<0.001 for trend).

The rate of hip surgery fell significantly as well, from 27.8 per 1,000 patient-years in 1998-2001 to 17.6 per 1,000 patient-years in 2007-2011 (P<0.001), and the rate of any small joint surgery (i.e., hands, wrists, feet and ankles) also fell significantly, from 43.8 per 1,000 patient-years in the earliest time period to 30.5 per 1,000 patientyears in 2007-2011 (P<0.001).

The rate of knee surgery remained fairly constant over the study period: 12.3 per 1,000 patient-years in 1998-2001 and 12.9 per 1,000 patientyears in 2007-2011.

The strongest predictors of needing surgery over the years were female sex and level of disability on the HAQ at baseline, Dr. Hekmat said.

Fehmida Zahabi, MD, of Texas Rheumatology Care, in Plano, said she agreed with Dr. Hekmat about the link between more aggressive treatment of RA and reduced need for surgery.

“We are treating patients more aggressively now than in 1998 when this study started, and it is not wrong to guess that the decline in surgery is due to better management,” Dr. Zahabi said.

She also emphasized the cost ramifications of these findings.

“This is the best of times and the worst of times in rheumatic diseases. We can treat arthritides early and make a big impact on the disease process. But the worst of times refers to the cost of expensive medications,” she said. “In our practice, we refer patients for orthopedic surgeons much less often than we used to, presumably due to better context of the expense of long-term disdisease control. Even though biolog- ability and the financial and personal ics are expensive, we need to consider cost of joint replacement.” the expense of biologic therapy in the —Alice Goodman

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20 I AnesthesiologyNews.com

FEBRUARY 2014

P A IN M E D I C I NE

Neuropathic Pain Trial Results Often Not Publicly Available Toronto—One-third of results from registered clinical trials of neuropathic pain treatments are not readily available, according to an extensive survey of neuropathic pain literature.

According to Michael Rowbotham, MD, scientific director of the California Pacific Medical Center Research Institute, in San Francisco, the unavailability of such a swath of trial results, compounded with publication bias, carries significant ethical, research and clinical implications.

“One problem is that the aggregating of these data tends to inflate treatment effect sizes,” Dr. Rowbotham said. “If you overestimate the effect size, you really harm everyone. Physicians and patients get inappropriately high-efficacyy expectations; future trials are designed to be underpowered because they’re looking for a bigger effect than they really should be and from an ethical perspective, not sharing the findings wastes the contributions of patients who have entered clinical trials and agreed to the possibility of experiencing unknown risks.”

Congress requires clinical trials conducted in the United States to be registered on clinicaltrials.gov and that some trial results be posted on the website within one year of a study’s completion. However, previous research has found only 8% to 10% of all completed trials have accompanying findings on the registry ((JAMA 2012;307:651-653).

To capture a snapshot of registered clinical trials related to neuropathic pain, and the availability of trial results, Dr. Rowbotham and his colleagues created the Repository of Registered Analgesic Clinical Trials (RReACT), a project of the Analgesic Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION).

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“If you work really hard, use sophisticated search strategies and look at all public websites including the grey literature, you can get results from about two-thirds of studies” —Michael Rowbotham, MD

Their most recent research was a survey of the results from postherpetic neuralgia (PHN), fibromyalgia (FM) and diabetic peripheral neuropathy (DPN) trials registered on clinicaltrials.gov. They looked at the registry’s website, as well as peer-reviewedd journals, conference abstracts and press releases. The latter are referred to as “the grey literature.”

The results, which can be found at www.acttion. org, showed 373 registered studies on the three neuropathic pain conditions as of December 2011. In all, 184 trials were completed before December 2010, and therefore many should have had findings posted, as per the Congressional one-yearr deadline requirement.

However, the researchers’ comprehensive search yielded no findings for 24% of the DPN studies, 25% of the FM trials and 33% of the PHN studies completed before December 2010.

The proportion of complete and incomplete trials that had results available in any format ranged from 63% to 68%; only 39% to 44% of all findings were published in peer-reviewed journals.

“If you work really hard, use sophisticated search strategies and look at all public websites including the grey literature, you can get results from about two-thirds of studies,” Dr. Rowbotham said.

The grey literature is not a reliable source for findings, given that results are not peer-reviewed, Dr. Rowbotham said, adding that there are other problems with accessing these findings.

“One of the websites we relied on as a source for this analysis, disappeared,” Dr. Rowbotham said. “It took with it results from hundreds of trials, several of which we couldn’t find anywhere else.”

Dr. Rowbotham said analyses and reviews of published evidence need to consider not only the absence of up to one-third of findings, but also the documented problem of publication bias.

Publication bias received widespread attention when a 2008 study in The New England Journal of Medicine found that of 74 large, multicenter, Phase III trials of 13 antidepressant drugs approved by the

FDA, half were not published in the peer-reviewed literature, and findings that were published tended to be positive (N Engl J Medd 2008;358:252-260).

“Not only were positive results more likely to be published, but studies that were not positive, in the researchers’ evaluation, were often published in a way that conveyed a positive outcome,” Dr. Rowbotham told attendees at the 4th International Congress on Neuropathic Pain. “One way to do this is to promote a positive secondary outcome and devote lots of text in the paper as if it were the most important outcome.”

Although it is possible that some of the neuropathic pain trial findings that were found to be unavailable in the RReACT analysis may have been negative, Dr. Rowbotham’s team did not set out to identify why results were not available. A less insidious explanation is the “file drawer problem,” he said.

“Some studies seem to get published and others just languish, waiting for that final review and edit, or for time to start writing the manuscript,” Dr. Rowbotham said.

Despite the worrisome RReACT findings, health care stakeholders are increasing their efforts to improve the accessibility of clinical trial findings, said Swaroop Vedula, MD, PhD, a postdoctoral fellow at Johns Hopkins University, in Baltimore.

“We have a long way to go before trial protocols and findings are reported completely and transparently,” said Dr. Vedula, who has studied the reporting of gabapentin trials and is not involved in RReACT. “However, there are several important initiatives, including a big push lately for open access to trial data, that are changing our understanding of the accuracy of clinical trial reporting and making clinical trial data and documents publicly available.”

—David Wild Dr. Rowbotham reported receiving research funding from the FDA. Dr. Vedula reported receiving fees from plaintiffs’ lawyers in litigation concerning gabapentin.

22 I AnesthesiologyNews.com

FEBRUARY 2014

P A IN M E D I C I NE

Algorithm Aims for Safer, Smarter Codeine Use

T

o avoid administering codeine to ultra-rapid metabolizers— individuals whose livers convert codeine to morphine so quickly the reaction can be fatal—clinicians at St. Jude Children’s Research Hospital, in Memphis, Tenn., have created an algorithm to help determine which pediatric patients can safely receive the analgesic.

Before ordering codeine, the hospital’s

electronic health records (EHR) system prompts physicians to request CYP2D6 genotyping, which can distinguish ultra-rapid or poor metabolizers from other patients. Variations in CYP2D6 have been shown to alter a person’s ability to metabolize codeine.

In February 2013, the FDA added a black box warning label stating that codeine is contraindicated for

adenoidectomy and tonsillectomy, citing deaths and serious adverse events in children who received the drug after these procedures. Despite this label, codeine remains an important analgesic, said Kristine Crews, PharmD, who codirects the pharmacokinetics research center at St. Jude and presented this algorithm at the 2013 annual meeting of the American

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College of Clinical Pharmacy (abstract 261). “Some children’s hospitals chose to take codeine off their formularies altogether,” she said, “but clinicians at St. Jude feel that codeine is good to have in the armamentarium.”

About 10% of patients are poor metabolizers, she said, and another 2% are ultra-rapid metabolizers. But codeine is a valuable option for up to 88% of the remaining patient population, Dr. Crews said.

If hospitals completely replace codeine with other analgesics, they run the risk of relying on drugs that may be less understood, said Howard McLeod, PharmD, director of the Personalized Medicine Institute at the Moffitt Cancer Center, in Tampa, Fla., who was not involved with the research. Such alternatives, he said, may not have accumulated an equivalently large body of clinical knowledge.

To keep codeine in the armamentarium, however, clinicians at St. Jude must ensure children who are poor or ultra-rapid metabolizers of codeine do not receive the drug. The hospital created a therapeutic algorithm for codeine administration, which is implemented via the EHR system.

Whenever a physician orders codeine, the EHR checks for the patient’s CYP2D66 genotype—if no genotype is on file, the algorithm reminds physicians to order a test. The system suggests other analgesics, such as morphine, hydromorphone or nonopioid pain relievers, for use in the interim. When a genotype result is on file, the algorithm will inform physicians whether or not codeine is safe to administer.

In the six months that the algorithm has been operational, “it has collectively fired over 500 times,” Dr. Crews said, adding that there have been no clinician overrides.

Dr. Crews said a similar system could be applied to other drugs in the future.

Dr. McLeod agreed. “By wiring the electronic medical records to include decision support tools, such as these,” he said, algorithms “can eliminate human error and give [clinicians] more time to focus on seeing patients.”

—Ben Guarino

FEBRUARY 2014

AnesthesiologyNews.com I 23

PA IN M E D ICIN E

Guideline Helps Taper Patients Off High-Dose Opioids

P

eople on extremely high doses of opioids can be tapered to lower doses gradually, while reducing both their pain and depression, new research shows.

“The post-taper morphine equivalent dose for some of these patients remained high, but it is still a significant improvement compared with their initial pain regimen,” said Raj Kalra, MD, medical director of the Chronic Pain Management Program at Kaiser Permanente Greater Southern Alameda Area, in Union City, Calif. He and his team presented the results at PainWeek 2013 (poster 45).

“It’s a dramatic improvement,” agreed David Juurlink, MD, PhD, head of the Division of Clinical Pharmacology and Toxicology at Sunnybrook Health Sciences Centre, in Toronto, Canada, who was not involved in the study. “Perhaps if they were tapered further, say to 50 or 100 mg of morphine or the equivalent, their pain and depression scores would go down even more. I wouldn’t be surprised because there’s good reason to believe that at least some of the suffering of patients on very high doses of opioids is actually a result of the drugs themselves.”

Dr. Kalra’s a group reviewed charts of patients with chronic pain who were managed at their clinic between December 2009 and April 2011. The patients were taking a morphine equivalent dose of at least 300 mg per day and had an average pain score of at least 6 on a 10-point scale. None had malignant pain, were addicted to opioids, had been on opioids for less than six months or were pregnant.

Patients were aged between 18 and 75 years; 13 (81%) were women. Ten had low back pain, while the other pain diagnoses included neck pain; neuropathy; pain in the shoulder, knee or pelvis; and fibromyalgia.

Opioids were reduced using a guideline in which the lowest dose was cut by 4% to 16% every five to 10 days until the dose had been reduced by 40% to 60%. Further dose reduction by 8% to 16% every five to 10 days followed. For patients taking more than one opioid, the second drug was tapered using the same steps as for the first. Dose reduction continued until the dose of every opioid was no more than 30% of the original dose.

For patients with opioid cessation as the goal, dose reduction was continued without a switch to an alternative opioid. Other patients were converted to

an alternative opioid. Dr. Kalra developed the guideline based on his clinical experience.

The patients benefited from the tapering; their pre- and post-taper scores on the Brief Pain Inventory indicated that their average pain was reduced, as was pain interference in their quality of life and activities of daily living. Average depression scores

on the Patient Health Questionnaire-9 fell from 13.5, or severe major depression, to 9.5, which is just below the cutoff for major depression.

Eighty percent of the patients experienced withdrawal symptoms, including anxiety, sweating or chills, muscle cramps or insomnia. No significant complications were noted.

“This is exactly the sort of research

that needs to be replicated,” Dr. Juurlink said. “There is a huge swath of the North American population taking very high doses of opioids yet continuing to suffer. In some cases, their pain gets worse as the dose increases. This approach perhaps could help many of them.”

—Rosemary Frei, MSc

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24 I AnesthesiologyNews.com

FEBRUARY 2014

P OLI C Y & M A NAGEMENT

OIG Opinion Adds Clarity to Illegality of Company Model

By Mark F. Weiss, JD

(AKS) even if no payment is A frequent contributor to Anesthesiology News, Mr. Weiss is made for a referral.l Under the an attorney who specializes in the business and legal issues n Nov. 12, 2013, the Office of Inspec- proposed arrangement, the psyaffecting physicians and physician groups on a national tor General (OIG) of the Department of chiatry group would have the basis. He holds an appointment as clinical assistant professor Health and Human Services released Advi- opportunity to generate a fee of anesthesiology at USC’s Keck School of Medicine and sory Opinion 13-15 dealing with a situation closely equal to the difference between practices with Advisory Law Group (dba The Mark F. Weiss the amount it would bill and akin to a “company model” deal.

Law Firm in Texas), a firm with offices in Los Angeles, Santa Underlying 13-15 was a proposed arrangement collect and the per diem rate Barbara and Dallas representing clients across the country. He whereby a psychiatry group performing electrocon- paid to the anesthesiologists. can be reached by email at markweiss@advisorylawgroup.com. vulsive therapy (ECT) at a hospital would capture No Safe Harbor the difference between the amount it collected for The OIG found that the proposed arrangement the carve out; and 3) the anesthesia group agreed to the anesthesia care of ECT patients and the per diem rate it would pay to anesthesia providers. would not qualify for protection under the AKS’s the carve out in exchange for access to the hospital’s Importantly, although not officially part of the safe harbor for personal services and management stream of anesthesia referrals. opinion, the OIG raised concern over the hospital’s contracts. Those safe harbors protect only payments Bottom Line grant of a carve out from an exclusive anesthesia con- made by a principal (here, the psychiatry group) to tract in favor of a referring physician. an agent (here, the anesthesia group). No safe harAdvisory Opinion 13-15 once again demonstrates bor would protect the remuneration the anesthe- a fact lost to many when discussing the “company The Facts sia group would provide to the psychiatry group by model” and similar potential AKS violations: These Initially, an anesthesia group held the exclusive way of the discount between the per diem rate their arrangements generally do not fit into an available contract to provide all anesthesia services at the hos- group would receive and the amount that the psychi- safe harbor—the personal services and the employpital. Then, in late 2010, a psychiatry group with a atry group would collect. ment safe harbors. Not only is this because payment practice centering on performing ECT procedures to the physician receiving the referral is not set in Although failure to fit within a safe advance and will vary with the value or volume of relocated to the hospital. “Dr. X,” board-certified referrals, but even more fundamentally because those in both psychiatry and anesthesiology, is one of the harbor is not fatal by default, the safe harbors apply only to payments from the prinowners of the psychiatry group.

In 2011, the anesthesia group began negotiating cipal to the agent, not to payments from the agent with the hospital for the renewal of its exclusive con- OIG again has illustrated that being to the principal. In 13-15, the discount that permits tract. The hospital demanded an initial carve out: put in a position to profit from one’s the referral source to profit from the arrangement is a Dr. X would be allowed to independently provide payment to the principal. anesthesia services to ECT patients.

Second, although failure to fit within a safe harbor referrals raises significant concerns The following year, when negotiating the 2012 is not fatal by default, the OIG again has illustrated renewal, the hospital demanded amendments to that being put in a position to profit from one’s referof prohibited remuneration—that the carve-out provision. Among them: Dr. X would rals raises significant concerns of prohibited remuis, of violation of the AKS. be allowed to provide anesthesia services to ECT neration—that is, of violation of the AKS. Note that patients and the anesthesia group would be required payment of so-called “fair market value,” the supto provide coverage for Dr. X. Because failure to comply with a safe harbor does posed holy grail of anti-kickback analysis, is not a Pursuant to what was called the “Additional Anes- not necessarily render an arrangement illegal, the panacea. Schemes that place the referral maker in the thesiologist Provision,” the psychiatry group would OIG analyzed whether, given the facts, the proposed position of profiting from its referrals are highly susdetermine if an additional anesthesiologist was arrangement would pose no more than a minimal picious even in the face of valuation studies and valuneeded for ECT anesthesia. If so, the anesthesia risk under the AKS. ation opinions. A pig in a skirt, even a designer one, group would negotiate to provide those services. If The OIG flatly stated that “the proposed arrange- is still a pig. the anesthesia group and the psychiatry group did ment appears to be designed to permit the psychiaThird, although not a part of the official opinion, not agree on terms, the psychiatry group or Dr. X try group to do indirectly what it cannot do directly; the hospital’s grant of anesthesia services rights to a that is, to receive compensation, in the form of a referral source might itself be a kickback. The concould contract with an additional anesthesiologist.

Subsequently, the psychiatry group informed the portion of the anesthesia group’s revenues, in return tractual right to the benefit of the carve out has value anesthesia group that an additional anesthesiologist for the psychiatry group’s referrals of patients to the and its grant can be remuneration. If that remunerwas needed. The parties began negotiating. anesthesia group for anesthesia services.” ation was an inducement for referrals to the facility, The OIG concluded that the proposed arrange- it was a kickback. This is completely on point with Under the proposed arrangement presented to the OIG, the anesthesia group and the psychiatry group ment could potentially generate prohibited remu- an anesthesia contract between a surgical center and would enter into a contract pursuant to which the neration under the AKS and that the OIG could an “anesthesia company” controlled by surgeons who anesthesia group would provide the additional ECT impose administrative sanctions in connection with bring their cases to that facility.

Although Advisory Opinion 13-15 provides imporanesthesia services. The anesthesia group would reas- the proposed arrangement. In other words, the OIG sign to the psychiatry group its right to bill and col- declined to approve the arrangement. tant guidance in respect of company model–type deals, lect for the services. The psychiatry group would pay Importantly, in connection with the relationship the issues remain highly complex and involve comthe anesthesia group a per diem rate. The psychia- between anesthesiology and other hospital-based pliance with a criminal law statute, the AKS. Anytry group would retain the difference between the groups and facilities, although not officially within one confronted by, or designing, an arrangement that the scope of the opinion, the OIG also stated that it potentially violates the AKS must obtain counsel well amount collected and the per diem rate. could not exclude the possibility that 1) the hospi- versed in the intricacies of the issues.

OIG’s Analysis tal pushed for the carve out to reward the psychiaThe OIG has stated on numerous occasions that the try group for its referrals of patients to the hospital; The author is the attorney for the anesthesia group that was the opportunity to generate a fee could constitute illegal 2) the hospital leveraged its control over anesthesia Requestor of Advisory Opinion 13-15 and represented it in connecremuneration under the federal anti-kickbackk statute referrals to induce the anesthesia group to agree to tion with its request.

O

Different situations require different sedative solutions Important Precedex Safety Information

The first and only alpha2 agonist indicated for sedation1-2

Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Nonintubated patients prior to and during surgical and other procedures.1 Initially intubated and mechanically ventilated patients during treatment in an intensive care setting.1

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.

Administer Precedex™ by continuous infusion not to exceed 24 hours.1

Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events.

Learn more at www.Precedex.com A right fit for today’s sedation management practices Please see the brief summary of Prescribing Information on adjacent page.

References: 1. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2008. 2. Kamibayashi T, Maze M. Clinical uses of α2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349.

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P12-3639, 10.5x13-May, 12. Printed in the USA.

For more information on Advancing WellnessTM, contact your Hospira representative at 1-877-9HOSPIRA (1-877-946-7747) or visit www.hospira.com.

Table 2 (continued): Adverse Reactions With an Incidence >2%—Intensive Care Unit Sedation Population <24 hours*

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Precedex®

Rx only

(dexmedetomidine hydrochloride) injection

Adverse Event

For Intravenous Use 1 INDICATIONS AND USAGE 1.1 Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.

Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.

1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex.

5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.

Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. in the treatment of most episodes of In clinical trials, glycopyrrolate or atropine were effective f Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required.

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.

In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex.

5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.

5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) Precedex subjects experienced at least 1 event 24 to 48 hours after end of study drug. The most common events were nausea, vomiting, and agitation.

Tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated.

Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)].

5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)].

6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth.

Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)].

Table 2: Adverse Reactions With an Incidence >2%—Intensive Care Unit Se dation Population <24 hours*

Adverse Event

All Precedex (N = 1007) (%)

Randomized Precedex (N = 798) (%)

Placebo (N = 400) (%)

Propofol (N = 188) (%)

Hypotension Hypertension Nausea Bradycardia Atrial fibrillation Pyrexia Dry mouth Vomiting Hypovolemia Atelectasis Pleural effusion Agitation Tachycardia Anemia Hyperthermia

25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2%

24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2%

12% 19% 9% 3% 3% 4% 1% 5% 2% 3% 1% 3% 4% 2% 3%

13% 4% 11% 0 7% 4% 1% 3% 5% 6% 6% 1% 1% 2% 0 – continued

Chills Hyperglycemia Hypoxia Post-procedural hemorrhage Pulmonary edema Hypocalcemia Acidosis Urine output decreased Sinus tachycardia Ventricular tachycardia Wheezing Edema peripheral

All Precedex (N = 1007) (%)

Randomized Precedex (N = 798) (%)

Placebo (N = 400) (%)

Propofol (N = 188) (%)

2% 2% 2% 2% 1% 1% 1% 1% 1% <1% <1% <1%

2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 0

3% 2% 2% 3% 1% 0 1% 0 1% 1% 0 1%

2% 3% 3% 4% 3% 2% 2% 2% 2% 5% 2% 2%

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6.

The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies.

Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 patients received Precedex for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3).

Randomized Dexmedetomidne (N = 387) 28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2%

Adverse Event Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain Hyperglycemia Acidosis Pleural Effusion Oliguria Thirst

3 4

Placebo (N = 379) 13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2% 2% 2% 1% <1% <1%

5 6

Respiratory depression2

37%

32%

Bradycardia3

14%

4%

Hypertension4 Tachycardia5 Nausea Dry mouth Hypoxia6 Bradypnea

13% 5% 3% 3% 2% 2%

24% 17% 2% 1% 3% 4%

Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or Diastolic blood pressure of <50 mmHg. Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 beats per minute or > 25% decrease from baseline.

Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value.

Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg. Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value.

Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

Table 7: Adverse Reactions Experienced During Post-approval Use of Precedex

Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidineor Midazolam-Treated Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study* Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Placebo N = 113 (%) 30%

6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Precedex.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5.

Dexmedetomidine (n=244) 56% 28% 42% 5% 28% 25% 10% 12% 11% 19% 9% 7% 7% 7% 6% 5% 5% 2% 2% 2% 1%

1 2

Table 3: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion <24 Hours ICU Sedation Studies

Precedex N = 318 (%) 54%

Adverse Event Hypotension1

Midazolam (n=122) 56% 27% 19% 1% 42% 44% 10% 15% 15% 30% 13% 2% 6% 2% 6% 6% 3% 1% 1% 6% 7%

† Includes any type of hypertension.

1 Hypotension was defined in absolute terms as Systolic blood pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value.

2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value.

3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value.

4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Body System

Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors

Cardiovascular Disorders, General

Blood pressure fluctuation, heart disorder, hypertension, hypotension, myocardial infarction

Central and Peripheral Nervous System Disorders

Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia

Liver and Biliary System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase

Metabolic and Nutritional Disorders

Acidosis, respiratory acidosis, hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia

Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

10 OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.

Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

Table 5. Number (%) of subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group Precedex mcg/kg/hr ≤ 0.7* N = 95

> 0.7 to ≤ 1.1* N = 78

> 1.1* N = 71

Constipation

6%

5%

14%

Agitation

5%

8%

14%

Anxiety

5%

5%

9%

Oedema peripheral

3%

5%

7%

Atrial fibrillation

2%

4%

9%

Respiratory failure

2%

6%

10%

Acute Respiratory Distress Syndrome

1%

3%

9%

Adverse Event

* Average maintenance dose over the entire study drug administration

Manufactured and Distributed by: Hospira, Inc. Lake Forest, IL 60045 USA Licensed from: Orion Corporation Espoo, Finland Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

FEBRUARY 2014

AnesthesiologyNews.com I 27

POL ICY & M A N A G E ME N T

Study Reveals Staggering Costs Of Ventral Hernia Repair Complications Mesh infection can lead to $100,000 price tag Washington—The cost of a mesh infection after ventral hernia repair can reach six figures for a single patient’s care in the year following surgery, according to a study presented at the 2013 clinical congress of the American College of Surgeons (ACS).

An analysis of the cost of complications in ventral hernia repair showed that a patient who develops a mesh infection after surgery will incur inpatient hospital charges of $44,000 plus an additional $63,400 in follow-up costs in the next year. Total expenses associated with a mesh infection came to $107,000.

In comparison, a patient without complications of hernia repair will incur hospital costs of $38,700 and an additional $1,400 in follow-up charges over the next 12 months, according to the analysis.

“We know that if you get an infection in hernia surgery, you may need a repeat operation with possibly a new mesh. It is expensive. We knew that. But it’s astounding how much repeat hospitalizations, repeat reoperations and clinic visits add up in terms of cost,” said co-author Paul Colavita, MD, a surgical resident at Carolinas Medical Center, in Charlotte, N.C. He presented the study at the ACS meeting.

It’s important that clinicians be aware of the costs of complications for procedures they regularly perform, said Benjamin K. Poulose, MD, MPH, assistant professor of surgery and director of the Hernia Center at Vanderbilt University Medical Center, in Nashville, Tenn.

“Surgeons need to become more involved with keeping costs at a reasonable level while improving quality of care for patients,” Dr. Poulose said. “This type of evaluation enables surgeons to take a good look at indications for a particular procedure and the risk profile for that operation, and the benefits we can offer patients.”

The study showed that all wound complications were associated with significant increases in cost. A single patient with a wound infection incurred inpatient hospital costs of $65,200, and an additional $20,200 for the next year. Wound complications, including wound breakdowns, seromas requiring interventions, and cellulitis, were associated with hospital costs of $51,800, and $6,200 in charges over the next year.

Table. Effects After Ventral Hernia Repair

At 1 year

Patients With a Complication

Patients Without a Complication

Hospital stay, days

8.3

5.8

More operation, %

32.2

1.0

More drainage by IR, %

19.5

0

IR, interventional radiology gy

The study was based on an analysis of 500 consecutive patients who underwent open ventral hernia repair between 2007 and 2011 at Carolinas Medical Center. The investigators assessed all inpatient charges during a patient’s initial hospitalization and charges for office visits, imaging, readmissions and interventions for one year.

The study focused on the financial experience of a single referral center that receives many high-risk patients. Even so, the investigators say they expect that patients treated at other institutions would incur similarly high costs.

Care costs escalated due to the additional interventions and visits needed for patients with complications, the study showed. Reoperations, drainage by interventional radiology, bedside interventions, extra days in the hospital and additional office visits accounted for much of the added expense.

Compared with patients who had no complications, patients with wound infections required an additional 4.3 postoperative visits, had longer hospital stays (8.3 vs. 5.8 days), underwent more reoperations (32.2% vs. 1.0%) and required more drainage by interventional radiology (19.5% vs. 0%). They needed more interventions of any type (70.1% vs.

0%). Interventions, lengthy hospital admissions and follow-up office visits also were more common among patients who developed mesh infections and wound complications.

The study is not the first to show that costs associated with infection are enormous. A 2004 paper published in The New England Journal of Medicine estimated that direct medical costs associated with such infections exceed $3 billion annually (2004;350:1422-1429). However, previous studies have not closely examined the costs of infection in ventral hernia repair.

Infections and wound complications are quite common in ventral hernia repair, with studies suggesting that one-third to two-thirds of these patients develop wound complications.

Complications have consequences far beyond cost, the investigators noted.

“Patients who have complications require more office visits, which means there’s a burden on the patient to travel to the clinic and to take time out of their day,” Dr. Colavitaa said.

“It’s also a burden on the physician and the physician’s staff, who now have to see a higher number of patients on clinic days. This impacts both patient and physician quality of life.”

The study confirmed that patients with complications experienced worse quality of life six months after surgery than those without complications.

Using the Carolinas Comfort SScale, patients Scal w wh who experienced a complication reported more discomfort (57.6% vs.

35.4%), greater limitations on activities (58.6% vs. 29.9%) and more mesh sensation (52.5% vs.

34.2%) than those without a complication.

Factors associated with complications such as infections included previous hernia repair, previous infection, active infection, defect area size and concomitant panniculectomy. Compared with patients who underwent repairs using biologic mesh, patients who were implanted with synthetic mesh had fewer wound infections (13.5% vs. 46.2%) and fewer wound complications (21.6% vs. 30.8%), but had more mesh infections (2.6% vs. 0%). The authors attributed the higher rates of infection and complication to an elevated risk profile among patients who had biologic mesh placement.

Women accounted for just over half of the study population (57.2%). The patients had a mean age of 56.4 years and a mean body mass index of 33.1 kg/m2, and 60.6% had a prior recurrence. The mean defect area was 198.3±293.9 cm2. Nearly onethirdd of the patients underwent a concomitant panniculectomy, and 25.8% had a component separation.

The investigators say they plan to do follow-up steps to identify the patients most at risk for these complications and develop strategies to reduce the risk.

—Christina Frangou

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Study Supports Adductor Canal Blocks After TKA Boston—An ultrasound-guided, single-shot adductor canal block can provide analgesia as effectively as a continuous femoral nerve catheter in patients undergoing knee replacement surgery, researchers have found.

“I think this study provides some valuable information that adductor canal blocks could be a good alternative to femoral nerve blocks,” said

Asokumar Buvanendran, MD, director of orthopedic anesthesia and professor of anesthesiology at Rush University Medical Center, in Chicago, who was not involved with the work. “It is a very good study.”

Femoral blockade is among the commonly used methods of analgesia after total knee arthroplasty (TKA), but it can lead to weakness in the quadriceps

that can increase the incidence of patient falls and limit physical therapy. Several nerves that innervate the knee traverse the adductor canal, and blocking this canal involves little motor involvement.

The adductor canal block of the femoral nerve occurs more distally, and therefore covers a smaller area of the leg, experts said. Previous research demonstrated that adductor canal blocks

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are effective in providing analgesia after knee surgery and can spare function of the quadriceps. The new study, presented at the 2013 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA; abstract 53) is among the first to directly compare outcomes between patients receiving adductor canal blocks and femoral nerve blocks after a TKA. For the study, investigators at Ochsner Medical Center reviewed the charts of patients who had undergone a primary, unilateral TKA at the New Orleans institution between June and October 2012. Patients in the analysis received either an ultrasound-guided, singleshot adductor canal block with bupivacaine (n=47) or a femoral nerve catheter with ropivacaine (n=41). Bupivacaine, 0.375% or 0.5%, was delivered in doses of 15 to 30 cc. Ropivacaine was bolused, followed by a continuous 0.2% infusion of the drug. All patients received patient-controlled hydromorphone.

Patients were excluded from the analysis if they had incomplete medical records or were unstable after surgery for reasons unrelated to their analgesia.

The investigators analyzed scores on the visual analog scale, opioid consumption and the need for rescue femoral blocks in patients at the time of discharge from the postanesthesia care unit (PACU), and then eight and 24 hours later.

Mathew Patterson, MD, an anesthesiologist at Ochsner Medical Center, reported that pain scores and hydromorphone use did not differ between patients receiving an adductor canal block and patients receiving a femoral nerve block at any of the time points measured. For the adductor canal block, pain control did not require a rescue block in 91% of patients discharged from the PACU, 83% of patients at eight hours and 70% of patients at 24 hours.

“Our patients who had adductor canal blocks were better participants in physical therapy,” Dr. Patterson said. “The adductor canal block can provide analgesia similar to the femoral nerve block.

In the future, we will look at ways of extending the duration of the block.”

A similar trial with similar findings was presented at the ASRA meeting (abstract 57). That study demonstrated that compared with continuous femoral nerve blocks, continuous adductor canal blocks may enable patients to walk greater distances immediately after TKA. —Kate O’Rourke

FEBRUARY 2014

AnesthesiologyNews.com I 29

CL IN ICA L A N E STH E SIOL OG Y

For Sciatic Blocks, Lower Dose Of Local Provides Ample Anesthesia San Francisco—Where 30 mL once stood as a standard dose, 10 mL now does the job.

So concluded a recent study by Illinois researchers of sciatic nerve block in patients undergoing total knee arthroplasty, which found that although 2.5 and 5 mL doses of local anesthetic provided suboptimal analgesia, amounts between 10 and 30 mL were comparably effective when paired with ultrasound guidance.

“We do a lot of regional techniques for total knee replacements, and we performed this study because we’re always looking for the minimum dose that will still offer the benefit we’re aiming for,” said Jessica J. Buren, MD, a fellow in regional anesthesia and acute pain medicine at Northwestern University Feinberg School of Medicine, in Chicago.

Dr. Buren and her colleagues enrolled 139 adults undergoing total knee arthroplasty into the trial. Each underwent a sciatic nerve block using the infraglutealparabiceps approach under ultrasound guidance and nerve stimulator assistance.

“We use ultrasound guidance to visualize the nerve sheath, which we call the common investing extraneural layer [CIEL],” said Dr. Buren, who presented the findings at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 1315). “With the nerve stimulator, the minimum current needed to get a response is very different if the needle is outside the CIEL or inside the CIEL.” Participants were randomized into 14 groups receiving 0.5% bupivacaine or 0.5% ropivacaine with epinephrine in amounts ranging from 2.5 to 30 mL. After local anesthetic administration, a blinded clinician assessed sensory and motor function every two minutes for 10 minutes, and every five minutes thereafter until one hour before surgery, researchers said.

After surgery, the clinician assessed the patient’s motor and sensory block every four hours until the anesthetic was completely resolved. A block was considered successful if it produced complete motor block and insensitivity to pinprick at the one-hourr mark in the sural, tibial, deep and superficial peroneal nerves.

“We found that in subjects where we used 5 mL or less of local anesthetic, we had 30 of 40 subjects with a successful block,” Dr. Buren told Anesthesiology

News. “By comparison, in the patients who received 10 mL or greater of local anesthetic, 97 of 99 had a complete block.

“What’s more,” she continued, “the patients who received 10 mL and greater had less pain behind the knee in the

said Chad M. Brummett, MD, assistant professor of anesthesiology at the University of Michigan Health System, in Ann Arbor, who moderated the poster session. “This is probably going to be the biggest change in regional anesthesia first 24 hours after surgery. They also practice in the coming years: volume and had a longer duration of motor block concentration. It will be interesting to [up to 56 hours], of course, which is not see how important a role concentration what we were aiming for, but is what we begins to play as we drop volume. Cerexpected.” tainly we can expect to see local anesThese findings are consistent with thetic toxicity drop off.” much of current literature on the subject, —Michael Vlessides

30 I AnesthesiologyNews.com

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C LIN I C A L A N ES THES IO LO G Y

CT Study Shows Anesthetic Spread Similar For Low, High Pressure Injections Findings suggest light touch better than heavy trigger finger

T

he delivery of anesthesia should not be a high-pressure job—at least according to the findings of a small study presented at the 2013 annual meeting of the New York School of Regional Anesthesia (NYSORA).

The study, conducted by Philippe Gautier, MD, of the Clinique Ste. Anne-St. Remi, in Brussels, and an international team of researchers, determined that the spread of injectate in the interscalene space was

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similar with an injection force of less than 15 psi or more than 20 psi. But high-pressure injections led to more patient complaints of discomfort and increased the risk for epidural spread, the researchers found.

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Previous studies have confirmed a link between high-pressure injections and nerve injury. As a result, clinicians typically monitor injection pressure to reduce that risk. However, Dr. Gautier’s study is perhaps the first to look at the effect of injection pressure on injectate spread using threedimensional computed tomography (CT).

“After assuring that motor response was not present with less than 0.5 mA and that the opening pressure was less than 15 psi on either side so as to decrease the risk for an intraneural injection, we assessed the spread with low versus higher injection pressure,” Dr. Gautier told Anesthesiology News.

“With our imaging approach, we demonstrated that low-pressure injections are more comfortable for patients and may have less risk for spread into the epidural space, possibly resulting in high neuraxial block.”

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Figure 1. Injectate contacted all three roots of the brachial plexus (C5, C6 and C7) and spilled over the surface of the anterior and/ or middle scalene muscles in all study participants, for both lowand high-pressure injections.

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Figure 2. At injection pressure greater than 20 psi, one study participant developed an epidural spread of injectate.

FEBRUARY 2014

AnesthesiologyNews.com I 31

CL IN ICA L A N E STH E SIOL OG Y Dr. Gautier and his colleagues compared low injection pressures (<15 psi) to higher injection pressures (>20 psi) in nine volunteers. Each of the participants received an injection of 10 mL of radiopaque NaCl 0.9% in both the right and left interscalene space using a 22 G stimulating needle and combined ultrasound-nerve stimulator guidance. The right interscalene space of each of the study participants received the low-pressure injection, and the left received the higher-pressure injection.

Using CT, the researchers observed that injectate administered at both pressure levels contacted the C5, C6 and C7 roots of the brachial plexus and spilled over the surface of the anterior and/or middle scalene muscles in every volunteer (Figure 1).

However, they also found that higherpressure injections yielded more patient complaints of discomfort; in addition, one higher-pressure injection resulted in substantial epidural spread (Figure 2).

“While the spread of the injectate was similar between injections at less than 15 psi and greater than 20 psi, we do not know whether this would hold for a greater extreme of pressures,” Dr. Gautier said. “Equally importantly, we anatomically demonstrated that low volume can be successfully used in clinical practice. Lowering the volume of local anesthetic could increase safety by decreasing the risk for systemic toxicity.”

The potential adverse effects of higher-pressure injections may be of most interest to anesthesiologists, said Jeff Gadsden, MD, director of regional anesthesia at St. Luke’s-Roosevelt Hospital Center, in New York City, who was not involved in the latest research.

He and his colleagues performed a similar study on patients receiving lumbar plexus blockade (Anesthesiology ( 2008;109:683-688).

“Certainly the brachial plexus sheath is a finite space with somewhat limited compliance and a lot of tightly packed neural tissue,” Dr. Gadsden said. “It is easy to imagine how a forceful injection could result in pain or paresthesia.

What is unclear is if this phenomenon would translate to other block sites such as the popliteal sciatic or the femoral nerve, where surrounding connective tissue and muscle planes are different. While pain on injection is fairly uncommon, it is a symptom that should be taken seriously, regardless of the injection pressure.”

Dr. Gadsden added that the new findings illustrate that all interscalene

brachial plexus blocks must be performed with injection-pressure monitoring. At St. Luke’s-Roosevelt, for example, anesthesiologists are trained “to adhere to an opening pressure” of less than 15 psi, regardless of injection site.

“It makes intuitive sense that injections near or around nerves should not be performed with high pressures; however, we are notoriously poor as clinicians at quantifying the force that is being applied to the system,”

Dr. Gadsden explained. “The answer to the question, ‘How high is too high?’ as it applies to opening injection pressure comes largely from experimental evidence, but we know that injections adjacent to nerves and plexi should exhibit low opening pressure.

In general, if your pressure is higher than 15 psi as you begin to apply pressure to the plunger, then your needle tip is not where you think it is.”

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CONTINUED FROM PAGE 1

extubation affects between 17% and 88% of patients, said Leif Saager, MD, assistant professor of anesthesiology at the Cleveland Clinic in Ohio, and leader of the new study. However, these trials used several different definitions of residual neuromuscular blockade, prompting the current investigation team to sample a broad spectrum of institutions with a consistent definition of the adverse event. Data from 10 centers, including community and teaching hospitals, went into the analysis.

In all, 328 patients (76% women) were enrolled in the trial, all of whom were scheduled for surgery lasting less than four hours. Due to problems with measurements, 255 were included in the analysis. To be included, participants had to have an American Society of Anesthesiologists (ASA) physical status score of 1 to 3, have received at least one dose of a nondepolarizingg neuromuscular blocking agent and had to be extubated in the operating room (OR).

Patients received routine anesthesia care as chosen by the anesthesia provider, including use of peripheral nerve stimulators. Clinicians used acceleromyography to assess neuromuscular function. Residual neuromuscular blockade was defined as a train-off four (TOF) ratio of less than 0.9 at extubation. Anesthesia providers and nurses in the postanesthesia care unit were blinded to these values.

“Overall, the incidence of residual blockade at a TOF ratio below 0.9 at extubation was 65%,” Dr. Saager said at the ASA’s 2013 annual meeting, where he presented the findings (abstract 1056).

“Moreover, we found that 31% of participants in the study had a TOF ratio of 0.6 or less at extubation. We thought these were both surprisingly high numbers.”

Neuromuscular blockade was reversed with neostigmine in 83% of patients, and peripheral nerve stimulation was used in 73%. Although not statistically significant, the odds of residual blockade were

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61% greater among patients receiving neostigmine (P=0.26) and 20% greater among those in whom a peripheral nerve stimulator was used (P=0.62).

The investigators acknowledged that these findings might reflect selection bias. Still, they said, the results underscore the limitations of current tools and practices used to reduce the risk for residual neuromuscular blockade. “Unfortunately we don’t have the nice outcome data that they have for Canada,” said Dr. Saager, referring to the site of the original RECITE trial (see Anesthesiology News, November 2013, page 1). “But I think it confirms that in the United States there is still a very high incidence of the residual neuromuscular blockade that probably leads to similar adverse outcomes as demonstrated in the Canadian data.”

Hiding in Plain Sight “It seems the true message here is that if you don’t measure residual neuromuscular blockade, you don’t see it,” said Andreas Hoeft, MD, director of the University of Bonn’s Klinik für Anästhesiologie und Operative Intensivmedizin, in Bonn, Germany. “The majority of patients are extubated too early.”

Dr. Saager agreed. “We don’t measure well enough; we miss a lot of things; and probably have a lot of

adverse outcomes that could be potentially avoided if we had better management,” he said.

Jonathan Yong, MD, global director of medical affairs at Merck, said it was “remarkable” that 31% of patients were extubated with a TOF ratio of 0.6.

“That worries me very much,” said Dr. Yong, whose company has been trying for several years without success to bring its reversal agent sugammadex to the U.S. market.

“The problem is we anesthesiologists extubate our patients and bring them to the recovery room, make our handover and go back to the OR for our next case,” Dr. Saager added. “So the decisions we make in the OR, we don’t get the direct feedback of the bad things that happen in the recovery room. So that probably doesn’t push us to change our practice very much.”

Andrea Kurz, MD, professor and vice chair of anesthesiology at the Cleveland Clinic, agreed that the deleterious effects of residual neuromuscular blockade are not always readily apparent. “What surprised me from the Canadian data is that there wasn’t much hypoxia,” Dr. Kurz said. “So it’s very difficult for the clinician to say if the patient is experiencing an adverse outcome.”

—Michael Vlessides

Ice Packs Shrink Post-Op Pain, Narcotic Use

C

ryotherapy can help reduce postoperative pain after abdominal surgery, according to a study presented at the 2013 annual meeting of the American College of Surgeons (ACS). When clinicians applied ice packs to surgical sites, patients reported less pain and used smaller amounts of narcotics compared with those given narcotics alone.

“I don’t think this is some kind of ‘miracle’ remedy, but it’s one more component in the armamentarium that health care providers can use to treat pain,” said coauthor Viraj Master, MD, PhD, professor of urology at the Winship Cancer Institute of Emory University, in Atlanta.

Previous research has shown that cryotherapy could reduce pain following gynecologic, hernia and orthopedic surgeries. his was The new trial was the first in which clinicians employed ice packs after major abdominal surgery, Dr. Master noted. Ammara Abbasi, MD, a surgery resident at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston, and the lead author of the study, presented the findings at the ACS meeting (JACS 2013;217:S131).

The investigators randomized 55 patients who had midline

incisions from abdominal surgeries into two groups. The cryotherapy group (n=27) received ice packs for at least 24 hours, in addition to morphine. Ice was applied for no more than 30 minutes per hour. Clinicians administered morphine alone to the control group (n=28). On postoperative days 1 and 3, ice packs significantly reduced mean postoperative pain scores compared with the control group (P<0.005), P based on twice-daily assessment on a visual analog pain scale. Patients in the cryotherapy group also consumed a smaller amount of narcotics, on average, one day after surgery compared with those in the control group

(P=0.008).

P There was no difference in hospital length of stay between the two groups.

“I don’t think [ice packs are] supposed to replace medications,” Dr. Master said. Instead, they should be used to complement other analgesics. “Most interventions to reduce pain are going to be multimodal.”

Cryotherapy did not increase risks for burning skin, wound infection or other adverse events. Ice packs also are cheap, at no more than $2 per bag, Dr. Master said.

“If we can get the community of surgeons and health care providers to use ice more frequently,” he said, “we’ve done our job.”

—Ben Guarino

American Society of Regional Anesthesia and Pain Medicine Advancing the Science and Practice of Regional Anesthesia and Pain Medicine

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REGIONAL ANESTHESIOLOGY AND ACUTE PAIN MEDICINE

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Annual Regional Anesthesiology and Acute Pain Medicine Meeting

April 3-6, 2014 Chicago, Illinois

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C LIN I C A L A N ES THES IO LO G Y BARIATRIC

CONTINUED FROM PAGE 1

including pneumonia, pneumothorax and atelectasis. But the latest work is the first to connect metabolic syndrome (MetS) with such problems in these patients.

“There have been studies with MetS surrogates that have looked at mortality, but not specifically pulmonary complications. This topic was attractive because this particular database in a specific patient population consists

of prospectively collected information, including patient conditions,” said Roman Schumann, MD, vice chair for academic affairs in the Department of Anesthesiology at Tufts, who led the study. Dr. Schumann presented his team’s findings at the 2013 annual meeting of the American Society of Anesthesiologists (ASA; abstract BOC05).

Comorbid conditions of MetS, such as obesity, dyslipidemia, hypertension and glucose intolerance, often improve after bariatric surgery, according to the

researchers. However, the incidence of MetS among obese patients who undergo bariatric surgery has not been well studied.

The longitudinal database is a prospective collection of data from participating bariatric centers of excellence and is affiliated with the American Society for Metabolic and Bariatric Surgery and the Surgical Review Corporation, a nonprofit company that accredits centers of excellence in bariatric surgery. The Tufts team looked

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at data covering procedures between January 2008 and December 2010 and included demographics, procedural information, ASA status (≥2), the presence or absence of MetSassociated comorbidities and pulmonary complications.

Dr. Schumann and his colleagues analyzed data from 158,405 primary bariatric procedures (52% gastric bypass; 40% gastric banding; 4% sleeve gastrectomy). Pulmonary complications included atelectasis, pneumonia, pneumothorax, pleural effusion, respiratory failure and acute respiratory distress syndrome.

The mean patient age was 45.7 (±11.8) years, and 78.5% were women.

The majority of patients (65.3%) had an ASA physical status of 3.

MetS was present in 20,158 patients, or 12.7% of the total. A significant association was found between MetS and all pulmonary complications except pneumothorax (Table 1). Pneumonia and respiratory failure were most strongly associated (both P<0.001).

“It is unclear whether the presence of MetS merely reflects a generally impaired physiological status that explains these findings, or whether the particular combination of the defining comorbidities is responsible,” the authors concluded. “Medical optimization of patients with MetS prior to surgery appears to be warranted.”

Stephanie B. Jones, MD, president of the International Society for the Perioperative Care of the Obese Patient and associate professor of anesthesia at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston, said the results were unsurprising. “I personally feel that obesity hasn’t gotten the full attention of anesthesiologists because the major majority of patients do fine, but with MetS, that’s where you start seeing the higher risk population. That’s who we should be looking at going forward, in terms of prospectively intervening.”

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CL IN ICA L A N E STH E SIOL OG Y Table 1. Pulmonary Complications After Bariatric Surgery Condition

Odds Ratio

95% CI

P Value

Atelectasis

1.40

1.13-1.74

0.002

Pneumonia

1.78

1.40-2.26

<0.001

Pneumothorax

0.52

0.12-2.22

0.57

Pleural effusion

1.46

1.04-2.05

0.03

Respiratory failure

3.86

3.01-4.93

<0.001

ARDS

2.24

1.27-3.93

0.008

Composite pulmonary adverse event

1.87

1.65-2.13

<0.001

ARDS, acute respiratory p y distress syndrome; y CI, confidence interval inteerval

Table 2. Risk for Transfer To Step-Down Unit Variable

OR

95% CI

P Value

Age

1.01

1.00-1.03

0.063

Female

0.87

0.55-1.38

0.57

OSA

2.11

1.34-3.30

0.001

BMI (per unit)

1.07

1.04-1.10

<0.001

BMI,, bodyy mass ass index; de ; OSA, OS , obst obstructive uct e ssleep eepp apnea app ea

Dr. Schumann added, “We don’t really know if these patients are just sicker and it makes sense that they run into trouble after surgery, or if it’s a special combination of changes that puts them at higher risk for certain adverse outcomes. We suspect inflammatory changes in the physiology may play an important not yet defined role in some of these observations.”

Dr. Jones said, “Part of the problem with these studies on MetS in general is that the definition has been sort of a moving target. But I do think it’s MetS rather than the comorbidities individually.”

In an unrelated study presented at the 2013 PostGraduate Assembly in Anesthesiology, New Yorrk City researchers found that a diagn nosis of obstructive sleep apnea (OSA A) and being overweight independen ntly predicted a patient’s odds off being transferred to a step-dow wn unit after surgery (P-9006).

“Transfers reflect ppatient outcomes and cliniccal decisions undertaken to prevent morbidityy and mortality, sugggesting increased postopperative complications in i the OSA and the higher” body mass indeex, the authors wrote ( Taable 2).

Naum Shaaparin, MD, director of o the Pain Service i n the

Department of Anesthesiology at Montefiore Medical Center, in New York City, who helped conduct the study, said patients who use continuous positive airway pressure (CPAP) machines at home are “automatically continued on CPAP postoperatively.” However, CPAP generally is not started postoperatively on other patients, for fear that the increased pressure into the esophagus and stomach might adversely affect the surgical site, Dr. Shaparin said.

Dr. Shaparin said the results have not changed practice at Montefiore— yet. “Once the final analysis is complete, we will arrange to present the data to the bariatric surgeons and the administration,” he said. “So, at the moment, there has been no change but we expect there will be a change once the data is presented.”

—Mandy Armitage, MD, with additional reporting by Adam Marcus

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C LIN I C A L A N ES THES IO LO G Y

Dose of Oxytocin Is Associated With Higher Epidural Drug Consumption San Francisco—Women who receive higher doses of oxytocin during labor require greater amounts of epidural analgesics, suggesting augmented labor is more painful, new research indicates.

Although previous studies support a correlation between augmented labor

and pain using pain scores, the new study is the first to assess epidural consumption in this situation, said Andrew W. Geller, MD, an obstetric anesthesiologist at Cedars-Sinai Medical Center, in Los Angeles. Dr. Gellerr presented his team’s findings at the 2013 annual

meeting of the American Society of Anesthesiologists (abstract 3140).

That higher oxytocin dosing results in increased pain during labor is important for two reasons, Dr. Geller said. Increasing cases of augmented labor will boost the use of anesthesia

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer.

Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery.

This activity is jointly sponsored by Global Education Group and Applied Clinical Education.

Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade.

Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel.

Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois

Challenge Questions 1. What would you do next?

2. What potential postoperative risks does this patient face?

Access this activity at www.cmezone.com/nmb1

services for these women. And the need for more epidural pain medication may be perceived by the patient as a failed epidural, which could negatively affect patient satisfaction—and, as insurers increasingly turn to such ratings to determine payments, ultimately the hospital’s bottom line.

The use of oxytocin for induction or augmentation of labor is increasing, with the overall rate of induction more than doubling between 1990 and 2006, according to recent literature. The investigators aimed to compare administration of oxytocin before delivery as calculated by area under the curve (AUC) with epidural drug consumption, also calculated as AUC. The retrospective review included 216 charts of first-time laboring women who received oxytocin for labor augmentation in 2008. The total AUC of oxytocin administered before delivery was calculated from the dosage rate and time interval of administration. The researchers also calculated an AUC for epidural medications from bolus and infusion dosing.

For this study, epidural analgesia consisted of a 0.2% ropivacaine infusion without narcotic in addition to boluses of ropivacaine, bupivacaine, lidocaine or chloroprocaine (with or without fentanyl). The researchers converted epidural boluses to ropivacaine--equivalent doses in milropivacaine ligrams by minimal local anesthetic

FEBRUARY 2014

AnesthesiologyNews.com I 37

CL IN ICA L A N E STH E SIOL OG Y concentration equivalency. To account for differences in the length of epidural use and to obtain an hourly ropivacaine equivalency rate, the epidural AUC was divided by the duration. The researchers compared oxytocin AUC in quartiles of exposure with the hourly ropivacaine-equivalent rate.

Increasing quartile oxytocin AUC was associated with increasing total (infusion and bolus) and bolus ropivacaine use in the augmented patients (P<0.0001). The increase in ropivacaine also was seen when the researchers compared mean hourly ropivacaine dosage with quartile oxytocin AUC (P=0.035).

Joy Hawkins, MD, professor of anesthesia and director of obstetric anesthesia at the University of Colorado School of Medicine, in Aurora, said she was not surprised by the results.

“We know that needing higher doses of oxytocin and increased pain in labor are markers for dystocia,” Dr. Hawkins said. “And we know that the need for higher doses of epidural medications— more top-ups—is a marker for dystocia leading to cesarean delivery. So this study goes along with all those associations.”

Interestingly, the rate of cesarean delivery nearly doubled between oxytocin exposure quartile 1 (16%) and quartile 4 (30%), although the interquartile rates were not statistically significant, Dr. Geller said. He hypothesized that dysfunctional labor could be leading to cesarean delivery and therefore higher doses of oxytocin, or that higher doses lead to cesarean

delivery. “It’s most likely the former, though,” he said.

Dr. Hawkins noted that higher rates of cesarean delivery would increase the use of anesthesia services.

Dr. Geller said he and his colleagues would like to compare epidural use and pain management requirements of women who do not receive oxytocin before delivery with those of patients who have augmented delivery.

Contact the editor of Anesthesiology News

amarcus@mcmahonmed.com

—Mandy Armitage, MD

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CONTINUING MEDICAL EDUCATION

FEBRUARY 2014

Lesson 308: PreAnesthetic Assessment of the Pediatric Patient With Pain: Part 1 WRITTEN BY:

CALL FOR WRITERS

Orvil Luis Ayala, MD Pediatric Pain Medicine Fellow Cincinnati Children’s Hospital Medical Center Department of Anesthesia Cincinnati, Ohio

If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at ElzFrost@aol.com.

LEARNING OBJECTIVES

REVIEWED BY: Alexandra Szabova, MD Pediatric Pain Medicine Fellowship Program Director Cincinnati Children’s Hospital Medical Center Department of Anesthesia Cincinnati, Ohio

DISCLOSURES The authors, editor, and reviewer have declared no conflicts of interest related to financial disclosures, research, and written presentation of this manuscript.

PROFESSIONAL GAPS Although most anesthesiologists appreciate the need to provide perioperative pain relief for their patients, perioperative pain in children remains undertreated. Part 1 of this 2-part series examines the barriers to treatment of pain in children and presents the means of assessing pain as well as other factors affecting acute pain management in the pediatric population.

TARGET AUDIENCE Anesthesiologists, certified registered nurse anesthetists, anesthesiologist assistants

At the end of the lesson, the participant will be able to: 1. Recognize some of the barriers to treating pediatric pain.

2. Discuss the developmental anatomy of nociception.

3. Present the controversies involved with perception of pain.

4. Highlight the development of understanding and reporting of pain by a pediatric patient.

5. Recognize the different tools used to assess pain in the pediatric population.

6. Discuss self-reporting measures used in the assessment of pain in the pediatric population.

7. Discuss the usefulness of observational scales used in the assessment of the nonverbal pediatric patient.

8. Understand other factors affecting the treatment of pain.

9. Discuss some of the techniques available to decrease perioperative anxiety.

10. Present general guidelines for the use of age-appropriate nonpharmacologic techniques in reduction of perioperative anxiety.

CASE HISTORY An 8-year-old boy with a past medical history significant for anorectal malformation and fecal incontinence was scheduled for a continent neo-appendicostomy under general anesthesia.

The patient was otherwise healthy. He lived with his parents and had recently completed the third grade. He weighed 25 kg, and his vital signs and physical examination were normal. The surgeon noted that postoperative pain could be significant. The surgeon and the parents asked that a plan for postoperative pain relief be in place and explained to them ahead of time.

T

he assessment and treatment of pain in the pediatric population present many challenges for perioperative physicians, especially the anesthetic care provider. Since the 1980s, several reports have indicated that pediatric patients in the perioperative setting are undertreated for pain compared with their adult counterparts.1 Many advances in the care of pediatric patients have occurred, including evidence-based practice guidelines for the treatment of pediatric pain to mitigate gaps in clinical practice.2 However, excessive pain in

the perioperative setting can lead to worse patient outcomes and development of chronic pain syndromes.3-5 The role of the perioperative physician is to understand and address barriers in pediatric pain management, and to improve pain management and thus patient outcomes (Table 1).6

Development of Pain Perception

Pain, as defined by the International Association for the Study of Pain (IASP), is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. The IASP also acknowledges that the inability to comTable 1. Examples of Barriers to Pediatric Pain Management municate verbally does not negate the possibility that an individual is experiControversies regarding when pediatric patients feel pain encing pain and is in need of appropriate Unfamiliarity with assessing pain in the pediatric population pain-relieving treatment.7 Inadequate or lack of parental/patient instruction/education Some experts have postulated that neoUnfamiliarity with pain treatments available for the pediatric nates are born with the ability to perceive population pain, given that the neuroanatomical system for pain is considered to be complete

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinaii in New York City. She is the author off Clinical Anesthesia in Neurosurgery (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City).

A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson posttest and course evaluation before January 31, 2015. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit.

TIME TO COMPLETE ACTIVITY: 2 hours RELEASE DATE: February 1, 2014 TERMINATION DATE: January 31, 2015 ACCREDITATION STATEMENT The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

39

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CONTINUING MEDICAL EDUCATION

by 26 weeks of gestation.8 Others have argued that the perception of pain requires an actual conscious recognition of noxious stimuli, which has been thought to exist once the thalamocortical pathways have matured and begun to function at around 30 weeks of gestation.8-10 A brief overview of the developmental anatomy of nociception and pain perception pathways is presented in Table 2.

These arguments and findings are relevant when one considers the need for anesthesia for mid- and endgestational fetal surgeries in which fetuses are actively treated with opioids to prevent any negative consequences that exposure to pain at such a young age might have. Advances in the field of perinatology have led to an increase in the survival of preterm neonates in neonatal ICUs.1 Many studies have demonstrated that failure to provide adequate analgesia to these patients can lead to negative sequelae, including motor and cognitive deficits, changes in sensory processing, and high susceptibility to growth retardation.11,14-16 It also is considered substandard and unethical care.

Assessment of Perioperative Pain in the Pediatric Population The initial step in successful treatment of perioperative pain in the pediatric population is assessment. Preoperative assessment may elucidate confounding factors, such as the presence of developmental delay, which may make the treatment of pain challenging. It also may provide a platform for discussion between the physician, health care staff, parents, and patients as to what can be expected during the perioperative period.

The assessment of pain in the pediatric population has been approached through the use of self-reporting scales, observational scales, and/or physiologic measures.

Becoming familiar with the available age-appropriate pediatric pain assessment tools may significantly improve patient care and outcomes (Table 3).17,18

Self-Reporting Scales The self-reporting scales used in the assessment of pain in the pediatric population rely on the patient’s ability to understand and express his or her pain, and thus have to reflect various developmental stages. Success and ease of use of a self-reporting scale depends on how well the implications of the child’s understanding of pain are incorporated in the assessment tool. It is important to note that between 36 and 60 months of age, children begin to report both the intensity of their pain and the emotions associated with it. This is the youngest age for which self-reporting scales have been developed, validated, and widely used in pain assessment. In our institution, we use a FACES rating for the younger age group and the numeric rating scale (NRS) for older children and adolescents (Figure).

Self-reporting scales are regarded as the gold standard of pain assessment. We recommend choosing 1 or 2 scales, training the medical center staff well, and using the scales consistently throughout the perioperative period (Table 4).19,20

Observational Scales Validated observational scales have been used in the perioperative setting for assessment of pain in the pediatric population (Table 5).11,19 Some of these scales are detailed, labor-intensive, and not practical for routine use, although they work well for intubated and sedated patients in the ICU, such as the Neonatal Infant Pain Scale (NIPS) or COMFORT Scale. For awake patients aged 0 to 18 years, we adopted the FLACC (faces, legs, activity, cry, consolability) scale, whose numeric value correlates with NRS,

Faces Pain Scale - Revised (FPS-R)

0

FEBRUARY 2014

This lesson is available online at www.mssm.procampus.net

2

4

6

8

10

making interpretation meaningful to all users. A challenge of observational scales is the lack of ability to differentiate between other forms of distress, including hunger, thirst, or anxiety.19

Physiologic Measures The physiologic measures are not as well validated as other methods of assessing pain but may provide some insight about the body’s response to pain. Measures may include heart rate, blood pressure, transcutaneous oxygen, respiratory rate, sweating, and stress response (Table 6).19 When using physiologic measures, it is important to note that these signs are not specific to pain and they work best when used in conjunction with other methods.

Other Factors Affecting Pain Assessment and Treatment in the Pediatric Population Even with the use of age-appropriate pain assessment tools, the potential for failure and complications persists. Factors such as anxiety or medication side effects may alter the treatment of pain in the pediatric population. Perioperative anxiety has been shown to predict higher pain scores and analgesic consumption postoperatively.20-24 Perioperative anxiety also can lead to long-term maladaptive behaviors. As a result, many studies have focused on interventions to reduce perioperative anxiety in children and their parents. Various pharmacologic and nonpharmacologic techniques have been shown to reduce anxiety, ranging from patient reassurance, distraction,25 and preoperative videos,26 as well as complementary and alternative medical therapies such as hypnosis, music therapy, and laughter therapy (Table 7).27 Parental presence in the induction room is a wellresearched technique for reducing anxiety in the pediatric population.28 It has its limitations,29 but is most effective

Table 3. Developmental Sequence of a Child’s Understanding of Pain

Age

Figure. The FACES Pain Scale.

Reprinted with permssion from the Internation Association for the Study of Pain.

Table 2. Developmental Anatomy of Nociception and Pain Perception Pathways8,11-13 Component of Pathway Developed

Gestational Age

Findings

Cutaneous nociceptive receptors

7-15 wk

Nociceptors in perioral area, palmar area, abdominal area

Spinal cord

8-19 wk

A fibers enter spinal cord before C fibers; by birth these fibers overlap in the substantia gelatinosa

Thalamic afferent fibers

20-24 wk

Fetus able to formulate stress response secondary to noxious stimuli

Functional cortex

29-30 wk

Thalamocortical pathways have matured and begin to function

Descending inhibitory pathways12,13

~21-40 d after birth

Premature descending inhibitory tone from higher in the central nervous system commences about 21 d after birth; descending inhibitory pathways mature at about 40 d after birth

Sequence of a Child’s Understanding of Pain

0-3 mo

No understanding of pain is apparent, although perceptual awareness is noted; memory of pain develops shortly after birth.

3-6 mo

Pain response is supplemented by the sadness and anger response.

6-18 mo

The fear of painful situations develops; words for pain (eg, boo-boo) become common; and the ability to localize pain also develops.

18-24 mo Able to use words to describe pain (eg, hurt).

24-36 mo Able to describe pain and attribute an external cause to it.

36-60 mo Able to indicate the intensity of pain and begins to use emotional terms to describe pain (eg, sad or mad).

5-7 y

Able to differentiate clearly levels of pain intensity; use of cognitive coping skills.

7-10 y

Able to explain why pain hurts.

>11 y

Able to explain the value of pain.

Modified from reference 17.

CONTINUING MEDICAL EDUCATION

FEBRUARY 2014

when combined with noninstrumental talk between patient and health care providers compared with parental presence alone or in combination with anxiolytics.30 Distraction is an effective and inexpensive technique to counteract anxiety that can be applied across the age groups.31 This method probably works through cognitive and motor absorption, as children tend to be oblivious or have a decreased regard for their surroundings.32 Such tools may include but are not limited to pacifiers, blankets, medical play, video games, and clowns.30,32

Perioperative pain management sometimes can be described as walking a fine line between comfort and medication-related side effects, such as sedation. The risk for adverse drug reactions may double in an overly sedated patient,21 which is a distressing situation for all involved. Further administration of opioids or other medications under such circumstances should be withheld or tapered.11 To prevent such incidents, many institutions have implemented routine assessment of sedation in patients on opioids. We use a modified Ramsay Sedation

Table 4. Examples of Self-Reporting Pain Scales Scales

Age Group

Description of Methods

Poker Chips Hester et al, 1979

3-7 y

Evaluates intensity of pain by choosing from 4 Available in Spanish poker chips that represent different levels of pain

The Oucher Beyer et al, 1984

3-12 y

Photographic scale designed to measure pain intensity http://www.oucher.org/the_scales.html

Available in multiple languages

FACES Pain Scalerevised (FPS-R) Hicks et al, 1993

4-12 y

Patient asked to point at the faces that best indicate the pain felt www.iasp-pain.org/FPSR

Requires minimal instruction; easy to use

Visual analog scale (VAS)

5-6 y to adult

Uses horizontal line (10 cm in length) with descriptor anchors of pain at the end points (Draw line that intersects with how much pain you are feeling)

Low cost

Numeric rating scale (NRS)

8 y to adult

Patient must understand number concepts

Easy to use and chart; no equipment needed

Scale in the assessment of sedation in the perioperative pediatric patient (Table 9). For safety reasons, if the Ramsay score is greater than 3, the administration of opioids or other sedation-enhancing medications is stopped regardless of the patient’s pain score.23

Conclusion When assessing pain in the pediatric population, the perioperative physician should have a consistent approach to evaluating the patient and to modifying the plan according to confounding factors throughout the perioperative course. Use of age-appropriate pain assessment tools, education of the medical staff on their use, and the creation of treatment guidelines based on assessment, all lead to improved pain management, patient satisfaction, fewer complications, and better outcomes.

References 1.

Schechter NL, Allen DA, Hanson K. Status of pediatric pain control: a comparison of hospital analgesic usage in children and adults. Pediatrics. 1986;77(1):11-15.

2.

MacLaren J, Kain ZN. Research to practice in pediatric pain: what are we missing? Pediatrics. 2008;122(2):443.

3.

Gauthier JC, Finley GA, McGrath PJ. Children’s self-report of postoperative pain intensity and treatment threshold: determining the adequacy of medication. Clin J Pain. 1998;14(2):116-120.

4.

Roth-Isigkeit A, Thyen U, Stoven H, et al. Pain among children and adolescents: restrictions in daily living and triggering factors.

Pediatrics. 2005;115(4):1118.

5.

Porter FL, Grunau RE, Anand KJ. Long-term effects of pain in infants. J Dev Behav Pediatr. 1999;20(4):253-261.

6.

Golianu B, Krane EJ, Galloway KS, et al. Pediatric acute pain management. Pediatr Clin North Am. 2000;47(3):559-587.

7.

Goldschneider KR. Long-term consequences of pain in infancy.

In: Berde CB, Rowbotham MC, eds. International Association for the Study of Pain: Technical Corner. IASP Newsletter. July/August 1998.

8.

Lee SJ, Ralston HJP, Drey EA, et al. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005;294(8):947-954.

9.

Derbyshire SW. Can fetuses feel pain? BMJ. 2006;332(7546):909-912.

Table 5. Examples of Observational Pain Scales Scales

Age group

Description of Methods

Neonatal Infant Pain Scale (NIPS) Lawrence et al, 1993

Premature and full-term infants <1 y

Facial expression (0-1) Cry (0-2) Breathing patterns (0-1) Arms (0-1) Legs (0-1) State of arousal (0-1)

COMFORT Scale 0-18 y Ambuel et al, 1992

FLACC Scale Merkel et al, 1997

Older children with developmental delays 1 m-7 y

0-2 = no pain to mild pain (no intervention) 3-4 = mild to moderate pain (nonpharmacologic intervention, reassess in 30 min) >4 = severe pain (nonpharmacologic intervention, possible pharmacologic intervention, reassess in 30 min)

No equipment needed Detailed Needs close RN:patient ratio Used before and after painful procedures Used in the NICU Example: http://www. anes.ucla.edu/pdf/ assessment_tool-nips. pdf

Alertness Calmness or agitation Respiration Physical movement Changes in blood pressure Changes in heart rate Muscle tone Facial tension

Total scores range from 8 to 40 A score between 17 and 26, indicates adequate sedation and pain control

Used in the ICU Intubated/sedated patients Example: http://painconsortium.nih.gov/ pain_scales/COMFORT_ Scale.pdf

Faces (0-2) Legs (0-2) Activity (0-2) Cry (0-2) Consolability (0-2)

1-3 = no pain to mild pain 4-6 = moderate pain >6 = serious pain

Very popular Easy to use Postoperative period Results are consistent and reproducible Example: http://lane. stanford.edu/portals/ cvicu/HCP_Neuro_ Tab_4/FLACC_Score.pdf

Table 6. Physiologic Measures in Pain Assessment in the Perioperative Period Heart rate

Most widely used, especially in infants and children; no longterm data evaluating pain and heart rate changes

Transcutaneous oxygen (SaO2)

Found to be decreased during painful procedures; may be secondary to changes in ventilation or stress-induced vasoconstriction; readily available measure in the ICU

Sweating

Shown to be useful in research as an indicator of distress; limited use in clinical practice

Stress response

Painful procedures, surgery, or trauma may lead to release of stress hormone (eg, corticosteroids, glucagon, growth hormone, and catecholamines); not specific to pain; useful in the context of research but limited in clinical practice

Modified from McMahon S et al. Measurement and Assessment of Pediatric Pain. In: Wall & Melzack’s Textbook of Pain, 6th Edition.

Philadelphia, PA: Saunders; 2013.

41

42

CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

FEBRUARY 2014

10. Lowery CL, Hardman MP, Manning N, et al. Neurodevelopmental changes of fetal pain. Semin Perinatol. 2007;31(5):275-282.

Table 7. Anxiolytics Administered in the Perioperative Period Medication

Route

Dose

Dosing Interval

Midazolam (premedication)

IV PO IN

IV: 0.025-0.05 mg/kg 6 mo-5 y (max 6 mg/dose) >6 y (max 10 mg/dose) PO: 0.5 mg/kg, max 20 mg/dose IN: 0.2-0.3 mg/kg, max 10 mg/dose

Every 4 h as needed

11. Gold JI, Townsend J, Jury DL, et al. Current trends in pediatric pain management: from preoperative to the postoperative bedside and beyond. Semin Anesth Periop Med Pain.

2006;25(3):159-171.

12. Fitzgerald M. Development of pain pathways and mechanisms.

In: Anand KIS, McGrath PJ, eds. Pain Research and Clinical Management. Vol. 5. Pain in Neonates. Amsterdam: Elsevier; 1993:19-38.

Diazepam (postoperatively)

IV PO

IV: 0.05-0.1 mg/kg PO: 0.1 mg/kg

Every 4-6 h as needed

13. Fitzgerald M. The neurobiology of chronic pain. In: McClain BC, Suresh S, eds. Handbook of Pediatric Chronic Pain: Current Science and Integrative Practice. New York, NY:Springer; 2011:15-25.

Lorazepam (postoperatively)

IV PO

IV: 0.05 mg/kg (max 2 mg/dose) PO: 0.05 mg/kg

Every 6-8 h as needed

14. Simons SHP, van Djik M, Anand KS, et al. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003;157(11):1058-1064.

15. Walco GA, Cassidy RC, Schechter NL. Pain, hurt, and harm. The ethics of pain control in infants and children. N Engl J Med. 1994;331(8):541-544.

Adapted from Cincinnati Childrenâ&#x20AC;&#x2122;s Pain Service Medication Dosing Guide, 2009 and CHMC Formulary.

Table 8. General Guidelines for Nonpharmacologic Techniques Used for Reduction of Perioperative Anxiety in the Pediatric Population Age and Developmental Barriers

Techniques

Emotional Support

Common Reactions

Infants (0-1 y) Attachment Basic trust Sensitivity to physical environment

Preoperatively: Provide parents with information about the procedure (eg, pamphlets, reading materials, etc) During: Child distraction Music Massage

Parental presence Items of comfort (eg, pacifier, blanket)

Crying Problems with sleep Generalized increase in irritability Pain

Toddlers (1-3 y) Separation anxiety Loss of autonomy

Preoperatively: Parental information Child therapeutic play Medical play During: Child distraction Music Massage

Same as infants, plus Home routines Simple explanations

Pain Verbal responses to pain usually are not reliable When restrained, patient often responds to painless procedures Invasive procedures tend to cause a lot of anxiety Resistance Aggression Regression

Preschoolers (4-5 y) Separation anxiety Moral reasoning Good vs bad

Allow child to pick coping strategies Provide follow-up to procedures Music distraction Medical play

Same as toddlers, plus Choices Positive reinforcement

Fears intensified with age/experience Fear of abandonment Guilt Anger/aggression Regression Breaks in schedule, loss of control, and unfamiliar place and people tend to cause more anxiety

School-aged (6-12 y) Altered body image Loss of privacy Loss of independence

Preoperatively: Therapeutic play Medical play Procedure-based images During: Distraction Music Massage Hypnosis Allow child to make more choices Actively involve child in procedure Discuss potential changes in physical appearance

Same as preschoolers, plus Positive reinforcement Encourage parental presence

Increased ability to identify and localize pain Lack of abstract thinking may cause patient to feel guilt Past experiences/caregiver response can affect pain reactions Capability to exaggerate pain Acting out Aggression Depression Regression

Adolescence (13-17 y) Loss of autonomy Loss of privacy Altered body image

Preoperatively: Procedure-based instructions During: Distraction Music Guided imagery Hypnosis Discuss possible psychological and physical changes postprocedure Increase chances for involvement in decision making for medical care

Same as school children, plus Encourage active participation

Can locate and describe pain accurately Increased desire to participate in medical decision making Can be hyper-responsive to pain Has a better understanding of the concept of death May become rebellious to treatment and medical care Depression Regression Aggression

Modified from reference 11.

CONTINUING MEDICAL EDUCATION

FEBRUARY 2014

16. Fabrizi L, Slater R. Commentary: exploring the relationship of pain and development in the neonatal intensive care unit. Pain.

2012;153(7):1340-1341.

Table 9. Ramsay Sedation Scale (RSS) Score Response

17. McGrath PJ, Craig KD. Developmental and psychological factors in children’s pain. Pediatr Clin North Am. 1989;36(4):823-836.

1

Anxious or restless or both

2

Cooperative, oriented, and tranquil

3

Responding to commands

4

Brisk response to stimulus

5

Sluggish response to stimulus

6

No response to stimulus

18. Treadwell MJ, Franck LS, Vichinsky E. Using quality improvement strategies to enhance pediatric pain assessment. Int J Qual Health Care. 2002;14(1):39-47.

19. McGrath PJ, Unruh AM. Measurement and assessment of pediatric pain. In: Wall & Melzack’s Textbook of Pain, 6th Ed. Philadelphia, PA: Saunders; 2013.

20. McGrath PJ. Pain measurement in children. International Association for the Study of Pain, Clinical Updates. 1995;3(2):1-8.

Guide on How To Use the RSS Note if the patient is awake If anxious and/or restless = RSS 1 If calm, oriented, and cooperative = RSS 2 If patient is asleep, test for arousability If patient responds to commands or voice = RSS 3 If patient asleep and response is slow and a stronger stimulus is applied: Brisk response = RSS 4 Sluggish response = RSS 5 No response at all = RSS 6 Modified from reference 23.

21. Vila H, Smith RA, Augustyniak MJ, et al. The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: is patient safety compromised by treatment based solely on numerical pain ratings?

Anesth Analg. 2005;101(2);474-480.

25. Lee J, Lee J, Lim H, et al. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg.

2012;115(5):1168-1173.

26. McEwen A, Moorthy C, Quantock C, et al. The effect of videotaped preoperative information on parental anxiety during anesthesia induction for elective pediatric procedures. Paediatr Anaesth. 2007;17(6):534-539.

27. Evans S, Tsao JC, Zeltzer LK. Complementary and alternative medicine for acute procedural pain in children. Altern Ther Health Med. 2008;14(5):52-56.

28. Powers KS, Rubenstein JS. Family presence during invasive procedure in the pediatric intensive care unit: a prospective study. Arch Pediatr Adolesc Med. 1999;153(9):955-958.

29. Cameron JA, Bond MJ, Pointer SC. Reducing the anxiety of children undergoing surgery: parental presence during anesthetic induction. J Paediatr Child Health. 1996;32(1):51-56.

22. Lentschener C, Tostivint P, White PF, et al. Opioid-induced sedation in the postanesthesia care unit does not insure adequate pain relief: a case-control study. Anesth Analg.

2007;105(4):1143-1147.

30. Vagnoli L, Caprilli S, Messeri A. Parental presence, clowns or sedative premedication to treat preoperative anxiety in children: what could be the most promising option? Paediatr Anaesth.

2010;20(10):937-943.

23. Ramsay MAE. How to use the Ramsay score to assess the level of ICU sedation. http://5jsnacc.umin.ac.jp/How%20to%20use%20 the%20Ramsay%20Score%20to%20assess%20the%20level%20 of%20ICU%20Sedation.htm. Accessed September 8, 2013.

31. Kleiber C, Harper DC. Effects of distraction on children’s pain and distress during medical procedures: a meta-analysis. Nurs Res. 1999;48(1):44-49.

24. Kain ZN, Mayes LC, Caldwell-Andrews AA, et al. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006;18(2):651-658.

32. Patel A, Schieble T, Davidson M, et al. Distraction with a handheld videogame reduces pediatric preoperative anxiety. Paediatr Anaesth. 2006;16(10):1019-1027.

Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the Web site, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com.

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Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Icahn School of Medicine at Mount Sinai, New York, NY.

Post-Test 1.

2.

3.

Which of the following is an example of an observational measure used to assess pain in a pediatric patient? a. Poker Chips b. Visual analog scale c. FLACC Scale d. FACES Scale Which of the following scales may be used to assess pain in sedated patients? a. COMFORT Scale b. Numeric Rating Scale c. The Oucher scale d. Poker Chips Which of the following is an example of the nonpharmacologic techniques involved in the treatment of pediatric patients? a. Massages b. Blowing bubbles c. Music therapy d. All of the above

4.

5.

Examples of barriers to the treatment of pain in the pediatric population include all of the following except ______. a. lack of familiarity with appropriate assessment tools b. lack of familiarity with drug options and dosing c. lack of parental/patient education d. presence of child life specialist on an inpatient unit The treatment of pain should be withheld in which of the following scenarios? a. A 3-month-old boy undergoing elective circumcision b. A 13-year-old boy s/p pectus excavatum repair with patientcontrolled analgesia and respiratory rate of 6 who requires supplemental oxygen to maintain saturation above 94% c. A 6-month-old girl undergoing congenital cystic adenomatoid malformation repair d. An 18-month-old boy undergoing pyeloplasty

6.

Which of the following is not part of the FLACC Scale? a. Face b. Labs c. Activity d. Cry

7.

What Ramsay Sedation Scale (RSS) score does the following patient have: a 6-year-old boy s/p left inguinal hernia repair currently in the postanesthesia care unit, who is asleep but awakens to voice commands? a. RSS 6 b. RSS 8 c. RSS 1 d. RSS 3

8.

Which of the following are some of the consequences of administering opioids or other sedation-inducing medications to an overly sedated person? a. Severe hypercarbia b. Hypoxia c. Respiratory arrest d. All of the above

9.

High levels of parental anxiety may lead to higher anxiety levels in the pediatric patient during the perioperative period. a. Almost always b. It is unrelated c. Never d. Depends entirely on the preoperative mental condition of the child

10. Which of the following will help reduce anxiety during the perioperative period in an adolescent patient? a. Involving patient in decision making b. Hypnosis c. Procedure-based instructions d. All of the above

43

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AnesthesiologyNews.com I 45

PR N

Hemorrhage Claims Higher in OB And Spine Cases, not Trauma Recent analysis of claims against anesthesiologists from Closed Claims database highlights need for vigilance in nontrauma cases

San Francisco—The majority of claims against anesthesiologists involving hemorrhage were associated with obstetric emergencies, routine spine cases and minimally invasive procedures, according to new data from the Closed Claims Project.

The findings suggest that legal action may be more likely when hemorrhage is not an expected outcome, according to the authors, who highlight the inability to immediately recognize bleeding, especially in cases involving minimally invasive surgical techniques and postpartum situations, as a risk factor. In addition to early recognition, the researchers said, team communication and defined protocols for situations involving hemorrhage are critical.

“I was initially surprised there weren’t more trauma cases,” said Lorri A. Lee, MD, professor of anesthesiology and neurological surgery at Vanderbilt University Medical Center, in Nashville, Tenn., who presented the results at the 2013 annual meeting of the American

Society of Anesthesiologists (abstract 3002). “However, trauma claims associated with massive hemorrhage against anesthesiologists may be rare because the injury occurs outside the hospital setting, the patient often presents in severe distress and adverse outcomes are therefore less surprising.”

Dr. Lee and her colleagues reviewed 76 hemorrhage claims from the past decade from the Closed Claims Project database of 9,799 claims. The 76 cases were then compared with 1,512 other surgical and obstetric claims.

The failure to recognize and appropriately treat hemorrhage can result in “high-severityy outcomes,” according to the researchers. Their goal was to identify patterns of harm and types of procedures associated with hemorrhage, in order to improve patient safety.

treatment (33% vs. 17%; P<0.001).

The most common procedures associated with hemorrhage claims involved obstetrics (38%) and noncervical spine surgery (25%), whereas laparoscopic and robotic surgical procedures accounted for 17% of the hemorrhage claims. One case involved trauma.

The data indicated that 96% of the hemorrhage claims involved mortality or permanent injury compared with 53% of the other surgical and obstetric cases (P<0.001).

“Less than appropriate care” was identified in 62% of hemorrhage claims (vs. 42%; P=0.001) and was associated with failure to recognize the hemorrhage in the operating room, ICU or postanesthesia care unit or failure to treat it aggressively when identified.

Other factors involved in poor outLess Than Appropriate Care comes included lack of aggressive The patients involved in hemor- resuscitative maneuvers with clotting rhage claims were younger (mean age, factors, return to the operating room, 42 vs. 48 years; P=0.008) and were calling for assistance or not obtaining more commonly receiving emergency adequate IV access, Dr. Lee said.

“The most common types of procedures associated with hemorrhage claims were … those where the blood loss may be unrecognized by the anesthesiologist or other physicians.”

According to Dr. Lee, “Hemodynamic instability should heighten suspicion for unrecognized hemorrhage. All anesthesiologists should be familiar with modern principles of resuscitation, and be prepared to implement them when massive hemorrhage occurs.”

Joy Hawkins, MD, professor of anesthesia and director of obstetric anesthesia at the University of Colorado School of Medicine, in Aurora, said the large proportion of obstetric cases in the claims registry did not surprise her at all. “Others have described the same problem of late diagnosis and response in obstetric patients,” Dr. Hawkins said. “In fact, the most recent Confidential Enquiries in Great Britain cited late and inadequate response to obstetric hemorrhage as a major problem leading to maternal mortality.

“Every anesthesiologist who does obstetric anesthesia has seen this problem of a near-miss or even a maternal mortality on L&D [labor and delivery] due to hemorrhage that wasn’t managed aggressively enough,” Dr. Hawkins said. “In addition, blood loss at delivery is consistently underestimated by all personnel (obstetricians, nurses, anesthesiologists) so personnel never think they have lost as much as they have.” She recommended immediate availability of anesthesiologists for resuscitations on L&D. She also recommended they be aggressive with labs, lines and blood products.

—Mandy Armitage, MD

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46 I AnesthesiologyNews.com

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OR Design Can Improve Efficiency San Francisco—Improving the design of an operating room to encourage clinicians to work more efficiently on their own and together can significantly increase the number of surgeries the suite can handle each day, new research shows.

The study, from Massachusetts General Hospital, in Boston, found that the innovative design, which allows simultaneous preparation of patients and supplies concurrently with an ongoing surgical case, helped efficiency by increasing OR throughput.

The new OR design has been in place since 2011 and incorporates two sterile preparation rooms between the four ORs, which open into a clean core for equipment and supplies. Instrument tables are set up in the sterile prep rooms and moved into the ORs during turnover. The 13 pre- and postoperative bays are adjacent to the ORs. The new design was a response to earlier research at Mass General related to the Operating Room of the Future (ORF) project, in which parallel processing was first introduced in the OR, said Aalok Agarwala, MD, MBA, assistant chief of general surgery anesthesia at the hospital. That project was a proof of concept that was designed and built to demonstrate new OR workflows and test new operating room technology. The previous research indicated that utilizing dedicated teams for OR preparation and induction could increase efficiency.

“At that time, however, the two processes that were done in parallel were the cleaning of the OR and setting up of instrumentation with induction of anesthesia. In our new process, the previous surgical case is run in parallel with the setting up of instrumentation for the next case,” said Dr. Agarwala, who presented his team’s results at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 4173).

Previous studies have shown that parallel processing of surgical patients is associated with improved OR throughput, according to the researchers. Their goal was to evaluate the performance of the new surgical suite design at Mass General compared with the old design.

“The new design was in part a result of the ORF project, and in part the result of an unpublished experiment—called the Pod Project—that was done at Mass General, attempting to replicate some of the parallel processing and higher efficiency that showed benefit in the ORF,” Dr. Agarwalaa said.

That experiment was “marginally successful,” he said, but lacked the dedicated team that the ORF had.

Many of the OR staff, including anesthesia and nursing, rotated through freely. “There was still some improvement in efficiency, but not as much as the ORF had shown,” he said. “Some of what was learned from both the ORF and the Pod project led to the new design, incorporating a sterile setup room in the OR suite.”

The researchers analyzed data from a single surgeon’s cases (N=1,218) that required anesthesia care 12.5 months prior to the new design, as well as data from 12 months after the opening of the new surgical suite. There was no difference in case mix between the two groups. Metrics that were evaluated for cases included total case volume, cases per day and time spent both in and out of the OR.

This analysis included 303 turnovers before and 405 turnovers after the opening of the new design.

In the previous OR suite design, 555 cases on 147 unique days were performed, for an average of 3.78 cases per day. With the new suite, the surgeon performed 663 cases on 153 unique days, for an average of 4.33 cases per day (P=0.05).

Mean non-operative time fell significantly by 12%, from 69 minutes before the new design to 61 minutes after (P=0.0001). No significant difference was found in mean operative time (49 vs. 47 minutes, respectively; P=0.54).

“The surgeons and anesthesiologists like the new design because it decreases the distance to see patients pre- and post-op, and it reduces time waiting for equipment setup,” Dr. Agarwalaa said.

Warren S. Sandberg, MD, PhD, professor and chair of the Department of Anesthesiology at Vanderbilt

University Medical Center, in Nashville, Tenn., called the study “a nice demonstration of something that hasn’t been tried before, which is to use a sterile setup area as a way to achieve parallel processing.”

Anesthesiologists have long done studies on ways to improve OR throughput and how to calculate the cost-effectiveness of such measures, Dr. Sandberg added. “This is another piece of work in a long tradition coming out of Mass General, where they have been innovative about increasing OR throughput for years. It’s a nice demonstration of something that hasn’t been tried before, which is to use a sterile setup area as a way to achieve parallel processing.”

There is more information to come, Dr. Agarwala said. “We have not yet analyzed cost-effectiveness data, but it is something we’re working on,” he said.

—Mandy Armitage, MD

A View of a Room: Inside the Hospital Suite of the Future

I

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The nonprofit firm’s designs for Patient Room 2020 sought to incorporate advances in architecture, health care technology and medical treatments into an

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The proposed design, NXT Health said, is a “conceptual proposal that demonstrated how the integration of these key components could streamline the delivery of care, improve patient outcomes and redefine the medical experience” in the years to come.

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