The September 2012 Digital Edition of Anesthesiology News

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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • S e p t e m b e r 2 0 1 2 • Volume 38 Number 9

40th Anniversary 1972-2012

Anesthesia Method Suggests Possible Cure For Post-trauma Stress

T

reatment options for patients with posttraumatic stress disorder (PTSD) are by no means universally effective. From yoga to sleep therapy, pharmacotherapy to traditional ccounseling, reported rates of improvement aare only between 20% and 30%. But an Illlinois anesthesiologist believes a staple of paain medicine—the stellate ganglion nerve blocck—may prove to be the standard of care for PTSD. Eugene Lipov, MD, medical director of Advanced Pain Centers in Hoffman Estates, Ill., said stellate ganglion blocks are effective in the

Review of Avoidable Regional Errors Exposes Shocking Lapses

A

mpule errors, syringe swaps and confusion over epidurals and IV lines are among the common causes of preventable drug-related mixx ups in regional anesthesia, two new studies have found.

In some cases, the errors defy explanation: patients receiving neuromuscular blocking agents and even tranexamic acid by epidural injection, missteps that have led to serious— sometimes lethal—harm.

see PTSD page 26

see regional errors page 24

INSIDE

Automation Shines Light On ‘Black Hole’ of OR Drugs

06 | CORRESPONDENCE Readers weigh in on Keynes and health care.

Bedside drug carts speed access, reduce diversion risk Baltimore—Ask pharmacy directors to cite a major safety or regulatory concern, and lack of control over medications used in the operating room will be on nearly everyone’s short list, according to Stephen L. Speth, RPh, the pharmacy manager at Indiana University Health Bloomington Hospital (IUHB), in Bloomington.

“For quite some time, this was a black hole for us,” Mr. Speth said.

“I felt we had decent control of

pharmaceuticals, but you never really know what goes on behind closed doors when there is no real-time information on medication use and little to no pharmacist oversight.”

That all began to change in March 2011, when IUHB placed automated anesthesia dispensing carts (ADCs) in its 14 ORs. By 2012, the strategy had achieved major gains in several medication management outcomes, including a 90% decrease in controlled substance discrepancies

10 | PAIN MEDICINE

and a more than 50% reduction in the time needed for cart restocking, Mr. Speth reported in a poster - ) at the 2012 Summer Meeting (41-T of the American Society of HealthSystem Pharmacists.

Nearly Complete Coverage The ADCs supply about 95% of the medications likely to be used during a procedure—a huge upgrade

Reporting pain—time for a change?

17 | CLINICAL ANESTHESIOLOGY Patient-controlled warming for TKA.

22 | CLINICAL ANESTHESIOLOGY Obesity complicates procedural sedation in peds.

29 | PRN Fast-tracking knee surgeries helps both patients and budgets.

see black hole page 30

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4 I AnesthesiologyNews.com

SEPTEMBER 2012

Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First: I never thought I’d live to see the day when supraclavicular

September 2012

block k was considered a safer blockk for an outpatient than an

The five most-viewed articles last month on AnesthesiologyNews.com 1. Inspector General Weighs In on Fee Sharing 2. Extubation: Making the Unpredictable Safer (Educational Review) 3. OB Anesthesia Gains Pedigree With Fellowship

interscalene block. That’s a remarkable statement, one that

4. Acute Airway Obstruction Following Intubation: A Clinical Dilemma (Educational Review)

you would not have heard 20 years ago.

5. SSIs After Joint Surgery Cost Hospitals Millions

Register for free @ AnesthesiologyNews.com to read these and other articles.

SEE ARTICLE ON PAGE 19.

Erratum As a result of an editing error, Figure 1 in the article “Extubation: Making the Upredictable Safer” (Anesthesiology News Guide to Airway Management, t August 2012, page 71) was reproduced incorrectly. Several cells in the depicted algorithm included the text “endotracheal tube” rather than “tube exchanger.”

A corrected version has been posted to www.AnesthesiologyNews.com. We apologize for the error.

ALAN KAYE, PHD, MD, New Orleans, LA

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6 I AnesthesiologyNews.com

SEPTEMBER 2012

C OR R E SP O NDENCE

Keynes Commentary Sparks Strong Response To the Editor:

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or those with an interest in economics, Dr. [ Jon] White’s commentary, “A Keynesian View of Health Care” ( July 2012, page 8), particularly draws attention. Lord Keynes’ influence on Western governments since the 1930s has been profound. Keynes was a proponent of

heavy government interventionism, central banking, fiat currency, the use of money depreciation and inflation in order to promote the concept of full employment, copious borrowing and debt, bailouts, price fixing and high taxation, to name a few. If any single economist could be linked to the current fiscal status of Western nations, it

would be John Maynard Keynes.

Any person who follows current events will recognize the economic disasters that loom throughout the European Union, with Greece and Spain leading the way. The United States follows closely behind with a $15 trillion national debt, a trilliondollar per year budget shortfall and

“It made the surgical procedure

much,much more fun, if it can be called as such!”

–Lynn S.

future expenditures promised to the citizenry that are unfunded to an amount that may run into many tens of trillions of dollars.

The author quotes Keynes’ assessment that “private-sector decisions about the economy sometimes lead to bad macroeconomic outcomes for the economy.” That may be true. What is not mentioned, however, is that an economy heavily influenced by a relatively small number of bureaucrats and academics, often educated beyond their intelligence, also will make bad decisions. In the latter case, those decisions become fixed by way of government diktat, regulation and law in such a way that productive change is much more difficult. Incentives are distorted on a grand scale, mal-investments (of other people’s money) are made that are hard to correct, and processes and entities that should be allowed to fail are bailed out and supported.

While the article describes the necessary fluid nature of medicine, the application of Keynesian principles to our profession is antithetical to that versatility; it discourages, if not punishes, any deviation from the mandated standards set forth by the governing

C pC a ClipChart Colorado: Anesthesiologists here lost another round in their efforts to prevent nurse anesthetists in the Rocky Mountain state from administering anesthetics without physician supervision.

An appeals court in August ruled against the Colorado Society of Anesthesiologists and the Colorado Medical Society, who had sued to block a move by the state government to opt out of a Medicare provision vision s req requiring qu physician oversight sight of CR sig C CRNAs. RNAs.

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SEPTEMBER 2012

COR R E SPON D E N CE bodies. I disagree with the author’s assertion that medicine “seems to be on a path of selff destruction.” I believe instead that the problems with medicine, its delivery and its financing are primarily the fruition of interventions into the doctor–patient relationship that have been shaped by 50 years of legislation, government–corporate collaboration, distorted tax law and perhaps well-meaningg but misguided entitlement expansion.

The full application of Keynesian economic principles to medicine will culminate in the deceptive promise of full access for all, but to a diluted value of medical services paid at fixed government rates through national debt with an ever-depreciatingg currency. I would say that many in our profession, in concert with politicians, have very nearly achieved just that.

—M. Todd Rice, MD Dr. Rice is an anesthesiologist in private practice in Arlington, Texas.

federal intervention in health care, with some grand principles on “the many ways the government can and should intervene in our health care system.” We were teased with the suggestion that physicians will be given great authority to apply these principles.

Dr. White did not address drug shortages, a recent hot topic in Anesthesiology News. Like many readers, I remember a time when drug shortages were practically unheard of. However, probably thanks to perfect application

of Keynesian principles in the manner the author describes, we now have medication shortages that complicate our lives to the point of patient risk.

In 2003, Congress passed the Medicare Modernization Act. Included were a series of complicated de facto price controls through average sales price requirements. Our president has promoted strict enforcement of this policy. Sadly, we see the results when critical injectable medications are unavailable because of disincentives

to manufacture them. We never heard of raw material shortages, insufficient manufacturing capacity or distributor hoarding until federal intervention distorted and politicized the basic economics of production. Further worship of the religion of John Maynard Keynes will bring shortages of more than just medications in health care.

—Sean S. Adams, MD The author is an anesthesiologist in Naperville, Ill.

Raise your standards for stopcock performance to ZERO

To the Editor was amused by the article “Keynesian View of Health Care” ( Jon C. White, MD, July 2012, page 8). The author proposed a number of reasons we need more heavy-handed

I

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8 I AnesthesiologyNews.com

SEPTEMBER 2012

P OLI C Y & M A NAGEMENT

FDA Rejects Blame for Drug Shortages

P

ushing back against a highly critical Congressional report, the FDA rebutted charges that it is largely to blame for a string of serious drug shortages that have left clinicians, hospitals and patients without important medications.

In June, the House Committee on Oversight and Government Reform issued a report entitled “FDA’s Contribution to the Drug Shortage Crisis,” claiming overzealous regulatory actions by the FDA have been driving the crisis. Although the report cited other factors, such as market concentration, for the supply problems, it said the agency’s role could be traced to the arrival, in 2009, of Obama appointee Margaret Hamburg as FDA commissioner.

The committee, chaired by Rep. Darrell Issa (R-Calif.), f noted that the number of warning letters issued by the FDA increased 42% from 2009 to 2010, and climbed another 156% from 2010 to 2011. In many cases, the report stated, companies that received the letters took their manufacturing offline to address

the FDA criticisms. Four of the five largest U.S. manufacturers of generic injectable products have curtailed manufacturing in response to FDA action, the report claimed.

But in a July 23 letter signed by Assistant Commissioner for Legislation Jeanne Ireland, the agency denied that it was “the root cause of this serious public health problem.”

Ms. Ireland stated that the number of drug shortages began to rise steadily in 2005, well before Dr. Hamburg’s appointment, and that most of the drug shortages have been attributable to manufacturing production problems, such as qualityy relatedd issues and delays.

The rest of the shortages was due to factors such as business decisions to discontinue products, difficulty obtaining raw materials and increased demand, the letter argued.

The steep increase in warning letters alleged in the report was misleading because most of the letters were unrelated to drug manufacturing; they were related to the new Center for Tobacco

Products, according to the agency. From 2008 to 2011, the level of drug manufacturing warning letters “remained relatively flat,” Ms. Ireland stated. The warning letters issued to drug manufacturers involved serious defects that posed a safety risk, the FDA claimed.

Defects serious enough to require stopping production included glass shards in injectable products and fungal contamination of products, the FDA said.

The committee suggested that the FDA’s field force, which performs site inspections and issues citations, is insufficiently concerned about the implications of their actions, even if the result is a shortage. But the FDA said it is committed to working with manufacturers to resolve problems so that shortages are avoided. The FDA reported that it has prevented or mitigated drug shortages by taking steps such as expediting reviews, identifying additional manufacturers who may be able to produce scarce drugs, and helping firms qualify new sources of a raw material in shortage. The FDA also may use

enforcement discretion to allow temporary importation of a non-U.S. U product.

“Looking at the committee’s report, I was very surprised,” said Erin R. Fox, PharmD, director of the Drug Information Service at the University of Utah Hospitals & Clinics, in Salt Lake City.

“There was no mention of quality and manufacturing problems, no mention of the scary things going on in factories.

I’ve read the inspection forms that document what FDA found in its inspections. FDA wasn’t saying, ‘We found uncrossed t’s and undotted i’s, and that’s why we’re mad at you.’ In injectables, they found glass shards and mold contamination, nonsterile products.”

Noting that she considered the FDA’s actions “correct,” she said, “It’s hard to comply, but high quality is first priority.”

Sarah Clarkk Lynn, an FDA spokeswoman, said her agency was “absolutely not” to blame for the shortages. “In fact, the FDA has been a major part of the solution for preventing and solving this public health problem,” she said. Dr. Fox pointed out that “FDA is not putting the glass shards in the medications.”

—George Ochoa

AnesthesiologyNews.com I 9

SEPTEMBER 2012

PA IN M E D ICIN E

Oxycodone Formula Seems To Cut Abuse, Misuse

T

hree studies presented at the 2012 annual meeting of the American Pain Society suggest that a reformulated, controlled-release version of OxyContin (oxycodone hydrochloride), introduced to the market by Purdue Pharma in 2010, may be fulfilling its intended promise: reducing the abuse and misuse of the opioid analgesic.

According to Paul Coplan, PhD, executive director of Risk Management and Epidemiology at Purdue, the studies, which were funded by the company and co-authored by its employees, are part of “a multifaceted research program dedicated to understanding how formulation changes may help impact the complex problem of misuse and abuse” of OxyContin in general.

Eeach of the three studies was designed to assess different aspects of the misuse and abuse of the drug, from exposures to OxyContin reported to poison control centers to law enforcement findings with regard to the street value of the drug.

“These preliminary data are part of a series of eight epidemiologic studies Purdue is conducting to evaluate whether reformulated OxyContin, in real-world conditions, will have an effect on misuse and abuse, and their consequences,” said Dr. Coplan, a coauthor on the three studies.

In one of the studies, Dr. Coplan and his colleagues compared the incidence of OxyContin exposure cases reported to poison control centers with those of single-entityy oxycodone and heroin—both before and after the introduction of the reformulated product (abstract 430). Using data provided by the American Association of Poison Control Centers’ National Poison Data System between July 2009 and June 2011, the investigators found that all OxyContin exposures (both original and reformulated) declined 18% after the reformulated drug was introduced to market in August 2010.

Single-entity oxycodone and heroin

exposures increased by 13% and 17%, respectively, over the same period.

In an observational study using data from the National Addictions Vigilance Intervention and Prevention Program (abstract 331), the research team found that after reformulated OxyContin was introduced, the number of prescription opioid abusers abusing OxyContin fell by 49%. Within this population, the

number of people who abused OxyContin orally declined by 30% and non-oral abuse (i.e., injection, snorting) of the drug in this population declined by 73%.

The results of these two studies indicate that abuse of OxyContin declined significantly during the first 11 months the reformulated product was on the market, according to the Purdue researchers.

You’re

In the final study (abstract 201), which was based on a survey of law enforcement officials participating in Purdue’s Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) system, researchers found that reformulated OxyContin had a mean street price of $0.65 per milligram, 22% lower than that of original see abuse page 13

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10 I AnesthesiologyNews.com

SEPTEMBER 2012

P A IN M E D I C I NE

Is it Time To Change the Way We Report Pain?

Dear Arizona Pain Specialists, Although we all know that pain is multidimensional, we still often measure it on a 0 to 10 scale because that is quick and simple for both the patient and the doctor. This oversimplification doesn’t seem to match our understanding of pain and doesn’t seem to address a patient’s true quality of life. What other options exist for measuring pain, especially if we are documenting reductions for clinical studies and future reimbursement changes?

—Measured in Manhattan Dear Measured,

Y

ou have voiced a concern that is shared by almost all pain physicians. All of us have seen patients who had dramatic improvements in their quality of life from an intervention, but failed to report a dramatic change in the numeric rating scale (NRS). I can think of an elderly patient with 9/10 pain who was homebound for much of the day. She underwent a series of epidurals and on follow-up was excited to report, “I have a life again.” She has been able to walk her dog every night, go to her church’s small group and is now planning a trip to see her grandchildren. She also was excited to report that her pain had decreased to 6/10, “the lowest it’s been in years.” If one were to track only her NRS, the intervention would appear to be a failure or to have provided minimal success (a 33% reduction in pain); clearly, however, the intervention has had a dramatic effect on her activities of daily living (ADLs) and her overall quality of life.

The way physicians and social scientists have measured pain has changed over the years, as our Advertisement

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understanding about pain has grown. Melzack and Wall’s 1965 gate control theory of pain demonstrated the interaction between psychological and physiologic factors in the pain process.1 Gate control theory made it clear that a purely biomedical model was inadequate: Pain is more than just its physical neurologic aspects. Over time, our understanding became more complex. Today, the biopsychosocial model is the dominant approach to understanding pain. It considers the dynamic ways that physiologic, psychological and social factors interact in a patient’s experience of chronic pain.2 Several physiologic aspects of pain can be measured, including the regions of the body affected, systems affected, range of motion, pathophysiology, temporal characteristics, intensity and onset. It has been well documented that concurrent psychological variables affecting pain perception also are important to assess.3 Empirical support exists for three types of psychological variables that contribute to a patient’s experience of pain. These include affective factors, such as depression, anxiety and anger; cognitive factors, such f as beliefs about pain, beliefs about controllability, selfefficacy, y cognitive errors and coping; and sociocultural factors, such as social learning mechanisms, operant learning mechanisms and respondent learning mechanisms.4 The multifaceted nature of pain makes the reliable and valid assessment of it a daunting task.

Measures for Clinical Use Some scales focus specifically on pain intensity.

Some commonly used scales are the verbal rating scale (VRS), visual analog scale (VAS) and the NRS. Originated by Melzack, the VRS is a simple, commonly used categorical pain rating scale.5 Patients select one of multiple descriptors that represent pain of progressive intensity. Some common descriptors include none, mild, discomforting, distressing, horriblee or excruciating. g On the VAS, patients are asked to place a vertical mark, indicating their current pain intensity, on a 10-cm horizontal line anchored by no pain on one end and worst pain imaginablee on the other. Pain severity is measured as the distance in centimeters between the zero position and the marked spot.6-8 On the NRS, patients are asked to provide their pain level using an 11-point scale, where 0 represents no pain and 10 represents worst possible pain.9 Studies have found that participants given the same stimulus of pain sometimes rate the severity of the pain differently.10 The same participants’ responses on the VAS

sometimes varied when presented with the same level of a painful stimulus at different times.10 This suggests that not all ways of measuring pain are reliable, and the VAS in particular may lend itself to less reliable results.

Some scales focus on aspects in addition to pain intensity, such as the Short-Form McGill Pain Questionaire (SF-MPQ) Q and the West Haven-Yale (WHY) multidimensional pain inventory, both of which include affective and sensory descriptors associated Q and the WHY measure with pain. The SF-MPQ the patient’s pain experience, others’ reactions to the patient’s pain and ADLs.11,12 Although these scales offer a valuable integrative approach to pain assessment, they individually do not encompass all aspects of pain (e.g., sociocultural, cognitive and affective factors). Many pain medicine physicians use the simple NRS scale, given that tools such as the WHY and SF-MPQ Q are time-consumingg and can be difficult to interpret.

A study by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) found that, in addition to the importance of assessing pain relief and improvement in physical and emotional functioning, a comprehensive outcome measure also must consider changes in “fatigue, sleep, home and family care, social and recreational activities, interpersonal relationships, and sexual activities.”13 In 2005, IMMPACT recommended several core outcome measures to be used in clinical trials14; however, few of these measures were designed specifically to evaluate the efficacy of pain management, or were normed on a pain population (e.g., Beck Depression Inventory, Profile of Mood States, etc.). Casarett et al15 found that in addition to the reduction of pain, patients commonly cited improvement in sleep and increased ability to function as meaningful clinical end points. Moreover, Robinson et al16 found patients considered decreased fatigue, distress and interference as indicators of treatment success.

In response to these concerns, the global pain scale (GPS) was created. The GPS was designed to capture the multidimensionality of pain but also to provide a single score that could be used to track changes (e.g., as the result of a clinical intervention).17 Rooted in the biopsychosocial model, the GPS assesses physical pain, affective effects of pain, specific clinical outcomes and the degree to which pain interferes with ADLs. Because the scale can provide one number encompassing each of these aspects, it allows clinicians to see the effects of interventions (e.g., a procedure might not initially reduce pain per se but increase mobility or reduce the need for medications—both clinically important outcomes that would not normally be measured in a pain assessment).

Although clinicians understand that pain and its effects are multidimensional, they also desire a single measurement to work with. For that reason, the simple NRS question, “What is your pain on a scale of 0 to 10?” is still the most-used scale, despite its shortcomings. It measures pain intensity but lacks psychological variables proven to be part of the patient’s pain see report page 12

SEPTEMBER 2012

AnesthesiologyNews.com I 11

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A. We have seen a definite shift from nerve stimulation toward dual guidance, now increasingly transitioning toward ultrasound-guided nerve blocks only. Ultrasound monitoring of regional anesthesia has become the preferred method for many nerve block applications. Today, even the finest anatomic structures, including peripheral nerves, can be identified in detail and anesthetized selectively using high-resolution ultrasound scanners.

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12 I AnesthesiologyNews.com

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P A IN M E D I C I NE REPORT

CONTINUED FROM PAGE 10

experience4 as well as clinical outcome measures and ADLs. Although we use several different approaches depending on a particular case, we tend to use the 20-item short form of the GPS most often. The scale was designed to provide answers to clinical questions, such as whether an intervention really makes a difference beyond a reduction in pain scores. It also seems to present the best balance

between comprehensiveness, simplicity and speed of measurement. We frequently use it as a bedside assessment of baseline functioning, and as a repeated outcome measure for assessing change over time in both acute and chronic pain states (although most of our work focuses on chronic pain).

The scale possesses great value in this circumstance, because it was designed to provide answers to clinical questions, such as whether an intervention really makes a difference beyond a reduction

in pain scores.

In assessing physical pain states, the GPS addresses the ceiling, floor and average pain over the past week, as well as current pain state. In assessing the psychological effect of pain on the patient, the GPS screens for fear, depression, tiredness, anxiety and stress. The GPS explores several specific clinical outcomes, including the effect of pain on the patient’s quality of sleep, comfort, medication consumption, independence and work (or daily task) interference.

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1 ASA Standards for Basic Anesthetic Monitoring, Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Del egates on October 21, 1986, and last amended on October 20, 2010 with an effective date of July 1, 2011) - Viewed 3-21-11 at ww.asahq.org/.../Standards%20 Guidelines%20Stmts/Basic%20Anesthetic%20Monitor ing%202011.ashx 2 Stoelting R and Overdyk F. Anesthesia Patient Safety Foundation, Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postoperative Respiratory Depression. Accessed August 25, 2011 at http://www.apsf.org/announcements. php?id=7.

3 Standards for Basic Anesthetic Monitoring. American Society of Anesthesiologists. Accessed 6/20/11 at http://www.asahq.org/For-Healthcare-Professionals/~/media/For%20Members/documents/Standards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitoring%202005.ashx

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Finally, the GPS assesses the patient’s perception of how the pain affects ability to complete several daily activities, including shopping at the grocery store, completing chores, enjoying the company of friends and family, exercising (including walking) and participating in hobbies.

In the interest of full disclosure, we must admit that several of the authors of this article were involved in creating the GPS, but it has been tested at Iowa State University and the results published in Pain Physician.17 This article presents the first reliability, construct validity and criterion validity tests from a sample of adults reporting chronic pain. The GPS demonstrated high criterion validity and high construct validity (including both convergent and discriminant validity). The criterion validity of the GPS was established by comparing it to two pain scales that have been previously validated for clinical work, the MPQ and the WHY. High correlations between similar subscales showed evidence of convergent validity for those scales, and lower correlations between dissimilar subscales showed evidence of discriminant validity. Construct validity also was demonstrated by correlating the GPS with the Perceived Stress Scale, as high pain should predict higher life stress.

We believe the GPS can be used as a standardized measure of treatment efficacy. It uniquely tracks clinical outcomes after a pain-relievingg treatment has been initiated. The GPS can be administered to the patient in the waiting room and scored by the support staff, thus resulting in a robust assessment of pain in one numeric score that the physician can employ to formulate treatment plans. For research, the GPS can be used to measure pain scores and to follow pain treatment efficacy. The GPS is available free for physicians’ use in their practices or research studies, at http://www.paindoctor.com/ global-pain-scale.

—Paul Lynch, MD, Tory McJunkin, MD, Douglas Gentile, PhD, and Ryan Tapscott, PhD Drs. Lynch and McJunkin own and operate Arizona Pain Specialists, a comprehensive pain management practice that provides minimally invasive, clinically proven treatments, with three locations in the greater Phoenix area. Drs. Lynch and McJunkin also provide consulting services to other pain doctors around the country through their partner company, Boost Medical. For more information, visit ArizonaPain.com and BoostMedical.com.

References 1. Turk D, Melzack R. Handbook of Pain Assessment.t New York, NY: Guilford Press; 2001.

SEPTEMBER 2012

AnesthesiologyNews.com I 13

PA IN M E D ICIN E ABUSE

introduction of the new formulation.

We are [also] interested in assessing OxyContin ($0.80-$0.81/mg ) and how changes in abuse of reformulated 31% lower than that of instant-release OxyContin compared with the origioxycodone products ($0.95/mg). The nal formulation historically vary by age researchers said the reduced price and demographic characteristics.” reflects a drop in demand for the prodEbby Varghese, MD, director of the uct; however, they acknowledge that interventional pain medicine clinic at further research is needed to determine the University of Missouri-Columbia, whether reduced demand “reflects a said reformulated OxyContin is “a decrease in abuse.” Purdue developed good thing” for the pain management the RADARS system in 2001, follow- community and for pain patients. ing reports of abuse associated with its “As demonstrated in these studies, as original formulation of OxyContin.

“While Purdue did reformulate OxyContin to make the tablet more difficult to manipulate for purposes of misuse or abuse, long-term studies are needed to make any conclusions about abuse, misuse and, certainly, safety of the product,” Dr. Coplan said. “Ongoing research is primarily longer followup, beyond 20 months after the CONTINUED FROM PAGE 9

well as in other articles written on the topic, there has been an increase in the use of the instant-release formulation of oxycodone and heroin after Purdue reformulated OxyContin,” said Dr. Varghese, who was not involved in the studies. “The new formulation of OxyContin addresses the issue of abuse and diversion to a degree in the patient population offered OxyContin, but does not address prescription opioid abuse and diversion entirely. Not all patients, given insurance issues and

prescriber preference, will be offered reformulated OxyContin, and other opioids still on the market are not tamper-resistant and are still being abused and diverted. It is [still] the physician’s responsibility to screen each patient for signs of behavior that may lead to diversion or abuse of opioids.”

—Brian P. Dunleavy Dr. Varghese reported receiving honoraria from Medtronic and being on the speaker’s bureau of Pfizer and Allergan.

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2. Gatchel R. Clinical Essentials of Pain Management.t Washington, D.C.: American Psychological Association; 2005.

3. Kanner R. Pain Management Secrets. 2nd ed. Philadelphia, PA: Hanley & Belfus; 2003.

4. Turk D, Gatchel R. Psychological Approaches to Pain Management.t 2nd ed. Washington, DC: American Psychological Association; 2002.

5. Melzack R. The McGill pain questionnaire: Major properties and scoring methods. Pain.1975;1(3):277-299.

6. Scott J, Huskisson, EC. Graphic representation of pain. Pain. 1976;2(2):175-184.

7. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: A comparison of six methods.

Pain. 1986; 27(1):117-126.

8. Tiplady B, Jackson SH, Maskrey VM, Swift CG. Validity and sensitivity of visual analogue scales in young and older healthy subjects. Age Ageing. 1998;27(1): 63-66.

9. Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain measurement: A ratio measure? Pain Pract. 2003;3(4):310-316.

10. Mader T, Blank F, Smithline H, Wolf J. How reliable are pain scores? A pilot study of 20 healthy volunteers. J Emerg Nurs. 2003;29(4):322-325.

11. Melzack R. The short-form McGill Pain Questionnaire.

Pain. 1987;30(2):191-197.

12. Kerns RD, Turk DC, Rudy TE. The West Haven–Yale Multidimensional Pain Inventory. Pain. 1985;23(4): 345-356.

13. Turk D, Dworkin R, Revicki D, et al. Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain. Pain. 2008; 137(2):276-285.

14. Dworkin R, Turk D, Farrar J, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1-2):9-19.

15. Casarett D, Karlawish J, Sankar P, Hirschman K, Asch DA. Designing pain research from the patient’s perspective: What trial end points are important to patients with chronic pain? Pain Med. 2001;2(4): 309-316.

16. Robinson M, Brown J, George S, et al. Multidimensional success criteria and expectations for treatment for chronic pain: the patient perspective. Pain Med. 2005;6(5):336-345.

17. Gentile DA, Woodhouse J, Lynch J, Maier JA, McJunkin T. Reliability and validity of the global pain scale with chronic pain sufferers. Pain Physician.

2011;14(1):61-70.

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Uniblocker shaft incorpor incorporates rpora a metallic, radio-opaq radio-opaque opaq mesh allowing forr smoother sm manipulation.

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

Peripheral NSAIDs Reduce Pain, Inflammation After Cesarean Delivery

A

dding a low-dose nonsteroidal anti-inflammatory (NSAID) to a local anesthetic delivered directly into a cesarean wound suppresses both pain and inflammation and reduces the need for analgesia after surgery, researchers have found.

Experts said the findings, presented at the 2012 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract B-P4), support the growing use of peripheral analgesics administered into surgical wounds for cesarean deliveries and other surgeries.

“This study suggests that peripheral administration of an NSAID like ketorolac may carry significant analgesic benefits for patients,” said Brendan Carvalho, MBBCh, associate professor in the Department of Anesthesia at Stanford University School of

Medicine, in Stanford, Calif., who led the work. “Continuous administration of small doses of analgesics within a surgical wound may be preferable to the higher systemic doses routinely used in post-cesarean delivery.”

The present study, which received an award for best paper at the conference, is the first to look at inflammatory markers of wounds as well as analgesic effects. It is part of a series of studies by the same group looking at the inflammatory response in surgical wounds and the effects of peripheral drug administration using this delivery system and bioassay technique.

The small, randomized double-blind controlled trial included 60 healthy women who underwent normal cesarean deliveries. They received standard spinal anesthesia with 12 mg of hyperbaric bupivacaine, 10 mcg of fentanyl and 200 mcg of morphine. A wound-instillation system was inserted subcutaneously immediately prior to closing the wound.

Patients were then randomized to receive one of three instillation strategies: bupivacaine 0.5% at 10 mg per hour, bupivacaine 0.5% with hydromorphone at 0.04 mg per hour or bupivacaine 0.5% with ketorolac at 0.6 mg per hour. The medication was infused for 48 hours after delivery.

Dr. Carvalho and his colleagues measured pain scores, use of analgesia and cytokines from wound extractions at four, 24 and 48 hours postsurgery.

Patients were offered an oral opioid analgesic as needed to manage postoperative pain (with a maximum allowable dose of 60 mg of oxycodone or 4 g of acetaminophen).

Researchers found that subcutaneous instillation of ketorolac with bupivacaine was associated with a greater decrease in pain (P=0.018) and analgesic use (P=0.02) compared with bupivacaine alone. Analgesic use, pain at rest and sitting and time to first analgesia were reduced by 15% to 35% in this group. Inflammatory markers, specifically interleukin (IL)-6 and IL-10, were significantly decreased when ketorolac was added to bupivacaine compared with bupivacaine alone. The anti-inflammatory and nociceptive effects of peripherally administered hydromorphone were less apparent.

This approach, if borne out, may make maternal side effects and the see peripheral page 16

AnesthesiologyNews.com I 15

SEPTEMBER 2012

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

Chronic β-blockade Does Not Preclude Epi Test Dose

U

sing an epinephrine test dose may help prevent intravascular injection in patients on chronic β-blocker therapy, Washington researchers have found. The study showed that, although β-blocker therapy may interfere with the hemodynamic response expected from epinephrine, injection of the hormone nevertheless alters the heart rate in individuals who receive it.

“Since the early 1980s, a number of studies have looked into what β-blockade does to the efficacy of the epinephrine test dose,” said Ryan Pong, MD, a member of the anesthesiology faculty at Virginia Mason Medical Center, in Seattle. “There is some suggestion from these studies that it may modify the heart rate response. It appears from our data that chronic β-blockade can alter the hemodynamic response to an epinephrine test dose,” Dr. Pongg said.

“However, we found that it is still possible, and an absolute change—either up or down—can be indicative of an intravascular injection.”

The previous research was conducted in healthy volunteers, not surgery patients, Dr. Pongg added. “We really couldn’t find any studies out there on chronic β-blockade and the efficacy of the test dose.”

With that in mind, Dr. Pongg and his colleagues enrolled 24 patients (11 women, 13 men) who had been taking β-blockers for an average of about six years. Each patient was randomized to receive an injection of either placebo or 15-mcgg epinephrine into a peripheral vein, after which the investigators observed the patients’ blood pressure and pulse rate for five minutes. The other solution then was injected, again followed by five minutes of observation.

Both the patient and the anesthesiologist were blinded to the injected solution.

The epinephrine test dose was found to raise heart rate by an average of 17.8 (±7.2) beats per minute (bpm) and systolic blood pressure by an average of 23 (±18.6) mm Hg (Table).

“The first thing we noticed is that it didn’t make a difference whether patients got the test dose first or second,” Dr. Pongg said. “We were feeling pretty good about our results until a patient came along whose heart rate dropped from 75 to 54 beats per minute after getting the epinephrine test dose. This threw a wrench into our system of determining what constitutes a positive test dose in these patients. So we then tried to use absolute heart beat change,

which would include those patients who have a decrease in the heart rate.”

Using this approach, the researchers found that a change in heart rate of at least 10 bpm resulted in a sensitivity of 0.8 and specificity of 1.0 for detecting intravascular injection.

Among the study’s limitations noted by the investigators were its exclusion criteria. “If you think about who’s

going to come to you on β-blockers, we excluded a lot of them because we didn’t want to do harm in our study,” Dr. Pong said. “So you have to decide for yourself how you can generalize these data to patients who come in with congestive heart failure or atrial fibrillation; we don’t know what to do with those patients. And remember that blood pressure is another tool to help you sort

out whether an intravascular injection has occurred or not.”

Ralf E. Gebhard, MD, professor of clinical anesthesiology at the University of Miami, in Florida, said that with only 24 patients, “you’re not really making a broad statement about population. I think it’s very important to point out that you really have to wait a see test page 16

NAROPIN® delivers a faster return of motor function than bupivacaine.1,2 A Block Well Done.

NAROPIN provides 8 to 10 hours faster return of motor function following total knee replacement 1 than bupivacaine (P<0.05).

P

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs.

To learn more about the clinical benefits of NAROPIN, visit www.naropin-us.com.

Important Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com.

Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions.

In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

Please see accompanying brief summary of Prescribing Information. www.naropin-us.com NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management.

References: 1. Beaulieu P, Babin D, Hemmerling T. The pharmacodynamics of ropivacaine and bupivacaine in combined sciatic and femoral nerve blocks for total knee arthroplasty. Anesth Analg. 2006;103:768-774. 2. Morrison LM, Emanuelsson BM, McClure JH, et al. Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine. Br J Anaesth. 1994;72:164-169.

Naropin® and logo are registered trademarks of APP Pharmaceuticals, LLC. APP ® and are trademarks of Fresenius Kabi USA, LLC. ©2012, Fresenius Kabi USA, LLC. All Rights Reserved. 0155-NAR-05-2/11

WHY COMPROMISE?

16 I AnesthesiologyNews.com

SEPTEMBER 2012

C LIN I C A L A N ES THES IO LO G Y Table. Hemodynamic Parameters After Placebo or Test-dose Injection

TEST

CONTINUED FROM PAGE 15

long time before you see the heart rate change,” Dr. Gebhard continued. “And we tend to not be so patient sometimes in our busy practices. That’s where I personally struggle with using a test dose with peripheral nerve blocks, because in order to do so you have to do incremental injections of local anesthetics—which most of us do—but then you have to wait after every injection for about a minute.”

Placebo

Test Dose

P Value

HR, bpm ↑

2.0±2.5

17.8±7.2

<0.01

HR, bpm ↓

4.0±3.0

4.8±5.1

0.58

HR absolute change

5.0±2.6

18.5±6.6

<0.01

SBP, mm Hg ↑

2.8±8.0

23.0±18.6

<0.01

MAP, mm Hg ↑

3.9±4.7

15.1±14.5

<0.01

DBP, mm Hg ↑

5.9±5.2

12.4±13.2

0.03

Time to peak HR, sec ↑

—Michael Vlessides

PERIPHERAL

56±17

DBP, diastolic blood pressure; p HR, heart rate; MAP, MAP, mean arterial pressure; p SBP, systolic y blood pressure p e

Naropin

®

(ropivacaine HCl) Injection BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.

CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics followingg arthroscopic p and other surgical g procedures p is an unapproved pp use,, and there have been post-marketing p g reports p of chondrolysis y in patients p receivingg such infusions. The majority j y of reported p cases of chondrolysis y have involved the shoulder jjoint;; cases of ggleno-humeral chondrolysis y have been described in ppediatric and adult ppatients followingg intra-articular infusions of local anesthetics with and without eppinephrine p for pperiods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods p are not associated with these findings. g The time of onset of symptoms, y p , g y Currently,y, there is no effective treatment such as jjoint ppain,, stiffness and loss of motion can be variable,, but mayy begin g as earlyy as the 2nd month after surgery. for chondrolysis; y ; ppatients who experienced p chondrolysis y have required q additional diagnostic g and therapeutic p pprocedures and some required q arthroplasty p y or shoulder replacement. p It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does nott ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivoo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving

bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions).

Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.)

ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin.

Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)

Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis

N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18

Naropin total N=1661 N 1661

(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)

N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13

Bupivacaine total N=1433 N 1433

(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)

Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)

Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia

N 77 49 42 18 17 14 13 13 11 10 8

Naropin total N=1661 N 1661

(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)

N 68 47 38 14 18 15 14 12 10 8 16

Dr. Pongg presented his group’s findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 419).

Bupivacaine total N=1433 N 1433

(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

CONTINUED FROM PAGE 14

systemic transfer of these medications to nursing babies less likely, Dr. Carvalho said. Still, he added, more research is needed to establish the safety profile of this technique and to better understand how it might affect wound healing or scarring.

“If efficacy and safety of direct administration of analgesics into surgical wounds is confirmed, peripheral administration of these medications may become routine, especially if we develop long-actingg preparations that don’t require a catheter to be placed into the wound for drug administration,” he said.

Patricia Lavand’homme, MD, PhD, of the Department of Anesthesiology at Louvain Medical School, in Brussels, Belgium, who has done work in this area, questioned whether some of the benefit of ketorolac might be lost given the high concentration of local bupivacaine used. Dr. Carvalho’s group previously had found the dose to produce pro-inflammatoryy effects using the same model.

“It is unknown what dose is sufficient to show a peripheral analgesic effect,” explained Dr. Lavand’homme, who was not involved with the latest study.

“Certainly, the results support a peripheral analgesic effect of NSAIDs, which could be very good adjuvants to local anesthetics, even better adjuvants than opioids.”

Peripheral analgesia is thought to have few side effects for the mother and the neonate and quickly frees the woman to care for her baby.

Dr. Lavand’homme said future studies should establish the effective dose of ketorolac for wound instillation, as the 15 mg per day used in the Stanford trial was well below the typical systemic dose of between 30 and 60 mg per day.

Dr. Lavand’homme and her team previously demonstrated the peripheral effects of diclofenac after cesarean delivery, but they used the regular systemic dose. Local administration of the medication was found to have a better analgesic effect than systemic diclofenac (Anesthesiolog y 2007;106:1220-1225).

—Amanda Crowe

APP Pharmaceuticals, LLC

0155-NAR-05-2/11

Rev. 11/08

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

Hot Enough for You? Patient-Controlled Warming for TKA

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erioperative hypothermia can be a problem for patients undergoing knee replacement surgery, but single-use, temperature-controlled gowns may help. The gowns both reduce the risk for hypothermia and appear to reduce the need for postoperative opioids, a new study suggests.

“Patient-controlled IV analgesia has been widely used with great efficacy,” said Bill Ong, MD, professor of anesthesia at the University of Manitoba, in Winnipeg, who led the study. “The reason we performed the study was to determine whether patient-controlled temperature warming would be more effective and more satisfactory for patients.”

Dr. Ongg and his colleagues studied 30 patients undergoing total knee arthroplasty (TKA) with bupivacaine spinal anesthesia and intrathecal morphine. Half were randomized to receive standard warm blankets while their counterparts received temperature-controlled gowns (Bair Paws, Arizant). The single-use Bair Paws gowns have portable warming units that blow warmed air. Hand-held units control the temperature of the air.

The researchers assessed opioid requirements in the first 48 hours after surgery; patients rated their satisfaction with the warming method using a scale ranging from 1 (very unsatisfied) to 5 (very satisfied).

Gown patients had a higher mean temperature on admission to the postanesthesia care unit than did patients who received blankets (36.5±0.3 C vs. 36.0±0.8 C; P<0.001), according to the researchers, who reported their findings at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1304123). One patient in the gown group was hypothermic (35.9 C) compared with three of those given blankets (34.5 C, 34.6 C and 34.7 C).

Blanket patients required significantly more opioids than their counterparts with gowns (53.6±37.9 vs. 31.9±11.7 mg; P=0.05) in the first 48 hours after surgery. Perhaps not surprisingly, gown patients reported significantly higher satisfaction scores for thermal comfort (5.0±0.9 vs. 3.0±0.8; P=0.004).

The superior temperature control offered by the patient-controlled gowns may have improved patients’ overall perioperative experience, including reduced stress, the researchers said. This may have contributed to reduced postoperative opioid requirements and greater satisfaction.

“Active patient-controlled warming should be assessed further,” Dr. Ong said. “Measures to provide better patient comfort and feelings of control may be another useful adjunct for pain relief.”

Robert E. Johnstone, MD, professor of anesthesiology at West Virginia University in Morgantown, said the trial was a good first step. “That forced-air

®

warming gowns perform better than standard blankets is not surprising,” said Dr. Johnstone, who was not involved in the work. “A more relevant comparison would be with other forced-airr devices in current use. That normothermic patients were more satisfied and needed less opioids than hypothermic patients also is not surprising, a welcome confirmation of current practices.

“Some patients will undoubtedly like selff controll of warming,” Dr. Johnstone added. “Many may be too sedated to use it, however, especially during surgery. As Dr. Ongg recommends, patient-controlled warming should be further assessed, and include use and value analyses.”

—Michael Vlessides

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Second Thoughts: Follow-up Study Finds No Link Between Anesthetic Depth and Cognitive Function After Surgery

I

n a follow-up to an earlier trial that found that depth of anesthesia influences postoperative cognitive dysfunction on the day after surgery, Swedish researchers have concluded that no such association persists one month later.

“The extent of surgical trauma and depth of anesthesia are two of several risk factors for postoperative cognitive dysfunction,” said Pether Jildenstål, CRNA, of University Hospital in Örebro. “The aim of this study was to determine the effect of depth of anesthesia

on postoperative cognitive dysfunction in patients undergoing major surgery.”

To that end, the investigators enrolled 32 patients (aged 40-94 years; American Society of Anesthesiologists [ASA] physical status I-III) scheduled for major head and neck surgery under

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general anesthesia.

All patients were anesthetized according to the institution’s standard departmental regimen of propofol, remifentanil (Ultiva, Mylan) or fentanyl before extubation, oxygen in air and desflurane. Cognitive function was evaluated using the Mini-Mental Test (MMT), Confusion Assessment Method and Cognitive Failure Questionnaire. Cognitive dysfunction was defined as a score on the MMT of less than 25.

“There are more sensitive tests of cognitive function, but they take a lot of time to administer,” Mr. Jildenstål said.

“We used the MMT in our previous study of more than 400 patients and it worked fine. So we think that it’s an accurate measure of cognitive abilities.

In addition, the literature supports the use of this method.”

The researchers found that auditory evoked potentials differed significantly between groups: 18 (range, 10-25) in the treatment group and 12 (range, 7-20) in controls (P<0.0001).

Patients in the treatment group also were found to require significantly less desflurane (end-tidal concentration, 4.5±0.4 vs. 5.1±0.7; P<0.001) and fentanyl (154±29.5 vs. 200±38 mcg; P<0.0006) than controls. But they observed no significant difference between groups in remifentanil requirements. Four patients in the treatment group (25%) received additional fluids and vasopressors compared with 13 controls (81%; P<0.0038).

On the first day after surgery, the researchers found signs of cognitive dysfunction in one patient (6%) in the treatment group and seven controls (43%; P<0.0373). Two patients experienced delirium, both in the control group. Yet when it came to the trial’s primary outcome—cognitive dysfunction one month after surgery—no difference was found between groups.

“It seems that depth of anesthesia is more important than extent of surgical trauma for postoperative cognitive dysfunction,” Mr. Jildenstål said. “However, we need more studies to confirm our findings.”

Andrea Kurz, MD, professor of anesthesiology and vice chair of the Department of Outcomes Research at Cleveland Clinic, in Ohio, noted see dysfunction page 21

AnesthesiologyNews.com I 19

SEPTEMBER 2012

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

For Shoulder Block, Site May Not Matter for Pt Satisfaction San Diego—Brachial plexus blockade is known to provide superior postoperative pain control after shoulder arthroscopy, but few data point to the best approach to the nerve network.

Perhaps it does not matter after all.

New evidence shows that patients perceive no difference in pain control or satisfaction with either a supraclavicular or interscalene block. Even so, the investigators, from the Hospital for Special Surgery, in New York City, noted that supraclavicular block might be preferable for its propensity to be less disruptive to hemidiaphragmatic function.

Paralysis of the diaphragm during surgery has been linked to increased postoperative morbidity.

“Shoulder surgery is well known to be one of the most painful surgeries, particularly in the ambulatory setting where patients may or may not have appropriate education about when to take pain medications,” said Stephen Haskins, MD, chief resident at NewYork-Presbyterian/Weill Cornell Medical Center in New York City, who helped conduct the study. “At the Hospital for Special Surgery, about 90% of these surgeries are done under brachial plexus block, so we decided to look more closely for any differences in postoperative pain control and patient satisfaction based on the specific approach we utilized.”

Dr. Haskins and his colleagues performed a prospective cohort trial on 100 patients undergoing ambulatory arthroscopic shoulder surgery under brachial plexus block. Patients completed an online or phone survey on postoperative day 2 or 3, during which they assessed postoperative pain, along with their level of satisfaction with the analgesia, the duration of the nerve block and the pain education they received before surgery.

The majority of the blocks—73%— were performed using the supraclavicu80

Interscalene block Supraclavicular block

70

Percentage

60

59

48 hours after surgery: 41% of patients who received a supraclavicular block and 26% of those who received an interscalene block experienced moderate to severe pain at rest—a statistically nonsignificant difference—whereas 84% and 97%, respectively, reported such discomfort with movement (Figure).

Average pain scores (using a 0-10 numeric rating scale) were similar for

the two blocks at rest and with movement (Table, page 21). Patient satisfaction with management of postoperative pain (using a 5-point Likert scale) also was similar.

Blocks lasted longer when bupivacaine was added to mepivacaine (mepivacaine-bupivacaine 12.9±6.2 hours vs. mepivacaine 9.6±5.3 hours; see shoulder page 21

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78

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lar approach, which is typical at the researchers’ institution, Dr. Haskins said. Most consisted of a combination of mepivacaine and bupivacaine, he added.

As Dr. Haskins reported at the 2012 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract P26), moderate to severe pain was common in the first

59

50 38

40 30

26

25 16

20 10 0

0

3

0-3 4-7 8-10 (P=0.01) (P=0.94) (P=N/A) Average Pain at Rest

19

4 4-7 0-3 (P=0.01) (P=0.94)

8-10 (P=N/A)

Average Pain With Movement

Pain Scores

Figure. Pain scores appeared similar for both approaches to brachial plexus blockade.

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Dex After Heart Surgery May Reduce Risk for Arrhythmias

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atients who receive dexmedetomidine after cardiac surgery are substantially less likely to develop atrial arrhythmias than those given propofol, researchers have found.

Arrhythmias after cardiac surgery contribute to a host of adverse events, so the study, by researchers from the Cleveland Clinic’s

Department of Outcomes Research, suggests that dexmedetomidine (Precedex, Hospira) might help improve outcomes in this growing patient population.

“Postoperative atrial arrhythmias are associated with a number of complications, including hemodynamic instability, cognitive impairment, thromboembolic events, congestive

heart failure, stroke and prolonged hospitalization,” said Abdulkadir Atim, MD, a research fellow at the Ohio institution, and a member of the study team. “Therefore, the prevention of atrial arrhythmias is an important goal to reduce morbidity and mortality.”

Like other α2 agonists, dexmedetomidine has anti-inflammatory effects

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that might help reduce postoperative atrial arrhythmias, Dr. Atim said.

For their study, Dr. Atim and his colleagues reviewed data from the Cleveland Clinic’s cardiac anesthesiology database on patients presenting at the institution between 2006 and 2010. The excluded patients younger than 18 years and the severely ill from the analysis.

The researchers compared postoperative administration of dexmedetomidine and propofol in relation to atrial arrhythmias occurring within three days of cardiac surgery. They also conducted a sensitivity analysis, considering 37 prespecified potential confounders for inclusion in a multivariable logistic model.

The researchers evaluated the electronic records of 17,776 cardiac patients, including 765 who received dexmedetomidine for postoperative sedation in the intensive care unit and 17,011 who received propofol.

The investigators found that the incidence of atrial arrhythmias was 16.3% in the patients who received dexmedetomidine and 16.2% in those given propofol. Yet after adjusting for 13 “imbalanced factors,” including alcohol abuse and preoperative cardiac arrhythmias, dexmedetomidine was associated with roughly a 25% lower risk (odds ratio [OR], 0.74; 95% confidence interval [CI], 0.60-0.91) for atrial arrhythmia relative to propofol (P=0.004). A stepwise sensitivity analysis yielded similar results (OR, 0.76; 95% CI, 0.62-0.94; P=0.01), according to the researchers.

“I think this is a nice example of how important the adjustment for potential confounding factors is,” said Andrea Kurz, MD, vice-chair of the Department of Outcomes Research and professor of anesthesiology at Cleveland Clinic. “Because obviously, patients who received and did not receive dexmedetomidine in the intensive care unit might have been different in regard to confounding factors.”

Harriet Hopf, MD, vice-chair and professor of anesthesiology at the University of Utah, in Salt Lake City, noted that some clinicians may be concerned about a potential link between large doses of dexmedetomidine and cardiac arrest. And she questioned whether the researchers observed more cases of cardiac arrest in the patients who received the drug than in those given propofol. see rhythm page 23

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CONTINUED FROM PAGE 19

P=0.02). However, patients reported no difference in pain scores at rest or with movement—and no differences in satisfaction—regardless of which local anesthetic combination they received.

The researchers found that patients were not clear on how long the blocks would last, although they did report being well informed about how to treat pain once the local anesthetic faded.

Dr. Haskins said the study provide some insight into which approach to choose in shoulder arthroscopy patients.

“Anytime you do an interscalene block you’re going to have hemidiaphragmatic paresis, while supraclavicular block has been shown to decrease that by as much as 50%,” he explained. “So if you know the patients are likely to have similar satisfaction and pain relief with a supraclavicular versus an interscalene block, then you can potentially use that as evidence that you should be doing the safer block for patients, particularly if they are at high risk for respiratory complications.”

Denise J. Wedel, MD, professor of anesthesiology at Mayo Clinic, in Rochester, Minn., was surprised at the study’s findings, but for other reasons: the increased use of ultrasoundguided supraclavicular blockade. “I never thought I’d live to see the day when supraclavicular block was considered a safer block for an outpatient than an interscalene block,” Dr. Wedel said.

“That’s a remarkable statement, one that you would not have heard 20 years ago.”

Despite the results, the investigators were still concerned about the relatively high pain scores reported by

DYSFUNCTION

CONTINUED FROM PAGE 18

that cognitive dysfunction after surgery is fairly uncommon in people under the age of 65 years, occurring in less than about 15% of patients. However, patients undergoing head and neck surgery may have a high incidence of postoperative delirium—which is a predictor of cognitive dysfunction, she said. “I also find it a little difficult to see how we can evaluate postoperative cognitive dysfunction on the first postoperative day,” Dr. Kurz added. “I think you have to be really careful because it’s very difficult to measure correctly, especially in the early postoperative period.”

Mr. Jildenstål reported the findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 784).

—Michael Vlessides

Table. Pain Scores and Patient Satisfaction After Shoulder Surgery Interscalene Supraclavicular Block (n=27) Block (n=72) P Value Average pain at rest

3.18±1.38

3.40±2.05

0.51

Average pain with movement

5.92±2.09

5.82±2.19

0.91

Satisfaction with duration of pain relief 4.38±0.76

4.15±0.75

0.82

Satisfaction with duration of numbness

4.23±0.92

4.06±0.75

0.59

Satisfaction with postoperative pain management

4.46±0.51

4.19±0.70

0.89

patients, Dr. Haskins said. “So in addition to multimodal analgesia, it may make sense to try to extend the duration of some of these blocks, or perhaps place patients on a longer-acting opioid so they have some basal pain control,” he concluded. “I find it surprising that the selff reported pain scores and patient satisfaction could be so high at the same time.”

—Michael Vlessides

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

Procedural Sedation More Complicated in Obese Children

O

bese children who undergo procedural sedation are at an increased risk for adverse events including respiratory problems, a recent study has found.

“If you are going to give procedural sedation to children, your risk for needing to provide airway repositioning, airway adjuncts and bag mask ventilation, and of running into airway

complications, is higher if the child is obese,” said Patricia Scherrer, MD, medical director of sedation services at Children’s Hospitals and Clinics of Minnesota.

Dr. Scherrer’s group presented its findings at the 2012 annual meeting

of the Society for Critical Care Medicine (abstract 831).

Peter Davis, MD, chief anesthesiologist at Children’s Hospital of Pittsburgh, said the study “goes along with the trend that being obese is detrimental to

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your health.” Researchers have shown that obesity complicates anesthesia and procedural sedation in adults, but this is the first time a study demonstrated that obesity adversely affects procedural sedation in a pediatric population. “It hasn’t been documented in children before, but it is not a surprising finding,” said Dr. Davis, a member of the Anesthesiology News editorial board.

Dr. Scherrer and colleagues queried the database of the Pediatric Sedation Research Consortium (PSRC), a conglomerate that has included between 28 and 35 institutions at any given time. Founded in 2001, the consortium prospectively enrolls and collects demographic and procedural information for all pediatric sedation procedures performed at centers in the PSRC. The database is housed at the Dartmouth Bioinformatics Service Center, in Lebanon, N.H. The investigators identified 28,792 patients in the PSRC whose body mass index (BMI) index could be calculated. They compared sedation-related outcomes, adverse events and required interventions for obese and nonobese patients. To be considered obese, patients had to fall in the 95th percentile or above in terms of BMI. Roughly three-fourths of the patients received propofol, either as a single agent or in combination with an analgesic. Other sedatives included chloral hydrate, dexmedetomidine (Precedex, Hospira), diazepam, etomidate, ketamine, methohexital (Brevital, JHP Pharmaceuticals), midazolam, pentobarbital and thiopental.

Adverse events overall were more prevalent in obese patients (6.1% vs.

4.1%; P<0.001), with small increases in airway obstruction (2.1% vs. 1.1%; P<0.005), oxygen desaturation (1.3% vs. 0.7%; P<0.005), laryngospasm (0.4% vs. 0.2%; P<0.005), prolonged sedation/recovery events (0.35% vs.

0.13%; P<0.05) and sedation failures (0.39% vs. 0.2%; P<0.05).

Although the relative increase for many of these complications was large, their absolute incidence was low. For example, the increase in laryngospasm doubled from 0.2% to 0.4%, but the complication occurred in only one of 250 of the children who were obese. r however, “in According to Dr. Scherrer, terms of the overall number of pediatric patients who have received procedural sedation in the United States around the country, it ends up being a

AnesthesiologyNews.com I 23

SEPTEMBER 2012

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

data on mortality from cardiac arrest, arrhythmias,” he said. “Dexmedetomi- candidates for dexmedetomidine?” but we don’t know if it’s from dexme- dine is a relatively new sedative agent, Here again, said Dr. Turan, the retAlparslan Turan, MD, associate pro- detomidine or other factors. But I can and our study supports the use of dex- rospective nature of the analysis likely fessor of anesthesiology in the Depart- tell you that there was no difference medetomidine in patients at high risk had an effect. “Patients who are diffiment of Outcomes Research, said such between the groups with respect to for atrial arrhythmias after cardiac cult to wean are more likely to be put a signal was “very difficult to pick up mortality.” surgery.” on dexmedetomidine than propofol,” Dr. Atim concluded that dexmeDr. Hopff also questioned the vast he said. “So I imagine there’s a selecin a retrospective analysis. We have detomidine may be preferable to pro- difference in propofol and dexme- tion bias here.” pofol for sedation in cardiac surgery detomidine use at the institution, and Dr. Atim presented the findings patients. “Our analysis of our surgical how that may have affected the results at the 2011 annual meeting of the substantial number of patients.” registry indicates that dexmedetomi- of the analysis. “Was it just that dex- American Society of Anesthesiologists In a multivariate logistic regression dine use after cardiac surgery is asso- medetomidine got introduced later, or (abstract 788). analysis, patients who were obese were ciated with lower incidence of atrial are patients being selected as potential —Michael Vlessides more likely to have minor complications (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.15-1.54) and moderate events (OR, 1.83; 95% CI, 1.51-2.21). No difference was identified for major adverse events.

Airway interventions were more common in obese than in non-obese patients, including repositioning (40.5% vs. 34.3%), jaw thrust (22.1% vs. 17%), suctioning (16.3% vs. 13.2%), placement of an airway (15.8% vs.

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GOPump® & GOBlock® Information on whether doctors used ideal, adjusted or actual body weight when dosing patients would have been helpful in interpreting the study data, he said. Dr. Scherrer said the database does not collect this type of information.

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24 I AnesthesiologyNews.com

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

CONTINUED FROM PAGE 1

Santosh Patel, MD, the researcher in the United Kingdom who conducted the studies, said he was inspired to investigate the issue after hearing about two cases of epidural drug errors—one involving a woman in labor and the other a routine surgery. “I was interested in what wrong drugs were given in place of local anesthetics, the clinical features and what were the shortand long-term consequences’’ of such incidents, said Dr. Patel, an anesthesiologist at Pennine Acute NHS Trust Hospital, in Oldham, England.

Dr. Patel presented his findings at the 2012 annual meeting of the International Anesthesia Research Society.

For both projects, Dr. Patel and colleagues searched Medline and Google Scholar for incidents involving epidural or intrathecal interventions.

Dr. Patel looked only at papers written in English.

Dr. Patel found 34 published cases of epidural or intrathecal drug errors involving both obstetric and nonobstetric cases (abstract S-197), and 13 cases for procedures performed during

Table. Drug Errors During Spinal and Epidural Anesthesia or Analgesia

pregnancy or the peripartum period (abstract S-329).

Ten of the cases involved obstetric patients. In nine cases, all of which were non-obstetric patients, neuromuscular blocking agents were delivered through an epidural. Intrathecal errors occurred in 10 cases.

Errors related to the epidural administration of rocuronium, succinylcholine and remifentanil required emergency airway management and intubation.

Epidural glutaraldehyde and intrathecal aminophylline caused paraplegia, the latter proving fatal. The epidural administration of potassium chloride caused reversible cardiomyopathy in a woman who had a caesarean delivery.

Three patients received intrathecal tranexamic acid; all of them experienced convulsions, refractory ventricular fibrillation and death within a few hours. In a few cases, systemic or epidural steroids or epidural saline were administered to limit damage to the spinal cord.

Many mishaps involved swapped and unlabeled or incorrectly labeled syringes, as well as confusion over catheters and IV lines. Ampule error

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Group

Drug Given (Number of Reports)

Muscle relaxants

Atracurium (2-IT, 1-ED), rocuronium (2), cisatracurium, vecuronium, pancuronium, succinylcholine

Electrolyte-based solutions

Magnesium sulfate (2), potassium chloride (2)

Analgesics

Paracetamol (3), remifentanyl, tramadol (IT), morphine (IT, large dose)

Vasopressor/antihypertensive

Ephedrine (2), metaraminol, labetalol

Anticoagulants

Tranexamic acid (3-IT), heparin

Antiemetics

Metoclopramide (IT), ondansetron

Miscellaneous

Neostigmine (IT), insulin, glutaraldehyde, tazobactam, aminophylline (IT)

ED,, epidural; epp du a ; IT,, intrathecal t at eca

proved fatal in four cases.

Dr. Patel said that the use of ampules of varying size, shape or surface texture might help address those errors.

“Sometimes with poor light and label design or if in a hurry, you could feel the difference through touch,” he said.

Focus on Obstetrics The second study looked only at obstetric cases and included data on labor and neonatal outcomes. The study was designed to determine whether errors lead to problems with the mother, her baby or both, Dr. Patell said.

The most serious cases occurred in elective settings, after the infants were delivered, he said.

Dr. Patel identified 13 cases via searches on Medline and Google Scholar. In two cases, the spinal failed and general anesthesia was needed. In another three cases, the epidural failed to produce anesthesia.

In three cases, epidural infusions of magnesium sulfate and paracetamol were given for a few hours. In one case, flaccid paraplegia and autonomic disturbances occurred, and in another case, severe cardiomyopathy required intra-aortic balloon pump and intermittent positive pressure ventilation after potassium chloride was injected into the epidural space.

In one case, a woman who inadvertently received a dose of tranexamic acid developed convulsions and refractory ventricular fibrillation and died. None of the other errors resulted in long-term residual neurologic or systemic consequences, Dr. Patell said.

As in the broader study, the causes of error involved ampule mix-ups, failure to check drugs, syringe swaps, confusion over infusion bags and catheters mistaken for IV lines. The study also cited lack of provider education, fatigue, poor lighting, and problems related to hospital supply and storage of medication as possible factors.

In addition to tactile ampules—with labels doctors could identify by touch— Dr. Patel suggested several prevention

measures including the use of colored labels for drugs and infusion bags, separate drug trays, prefilled syringes labeled with electronic bar codes, different connectors for epidural and intravenous injections, and policies or protocols for checking anesthetic and other drugs.

“These are preventable errors,” Dr. Patell said. “I hope this report might increase awareness.”

Kishor Gandhi, MD, MPH, director of regional anesthesia at Jefferson Medical College, in Philadelphia, said he was “surprised by the prevalence” of the errors.

“I have heard of situations where the wrong drug is injected into the epidural catheter, often with fentanyl or midazolam, but having an infusion started through the epidural catheter with potassium chloride is shocking,” Dr. Gandhi said. “These events occur because clinicians don’t take the time to check the syringe or think about what they are doing. Following safe protocols—labeling syringes and checking them before the drugs are injected or infusions are started—will prevent such events.”

Richard Smiley, MD, chair of the research committee of the Society for Obstetric Anesthesiology and Perinatology, said that evaluating a metaanalysis can be difficult because there is not enough detail in an abstract about y chief of the search methods. Dr. Smiley, obstetric anesthesia at Columbia University Medical Center, in New York City, also noted that information and cases regarding epidural and spinal drug errors may not be published regularly, and other sources including reports to the FDA and even news reports, may contain more occurrences of errors than published accounts.

However, Dr. Smileyy noted, anesthesiologists are interested in special connectors for spinal and epidural injection as a way to find a “hardware fix” for drug errors in this area, although such a system has not been developed yet.

—Tinker Ready

AnesthesiologyNews.com I 25

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

Clarity in Hindsight: Review Shows Prowess of GlideScope

A

long-term review by Canadian researchers has found that the GlideScope video laryngoscope delivers successful intubation in well over 90% of patients, and in 100% of cases when the instrument is used as a rescue device.

“There’s definitely a learning curve to all the video laryngoscopes out there, not so much in being able to visualize the cords, but in terms of advancing the endotracheal tube,” said study leader Andrew D. Milne, MD, assistant professor of anesthesiology at Dalhousie University in Halifax, Nova Scotia. “But for me, the GlideScope [Verathon Medical] is one of my go-to devices that I routinely use as part of my difficult airway regimen.”

Dr. Milne said his hospital began using the GlideScope shortly after its introduction about 10 years ago. “We were also one of the first centers in Canada to have a full anesthesia information management system [AIMS], so we saw an opportunity to look back and quantify our experience with the device.”

The Dalhousie group searched the institution’s AIMS between 2003 and 2009 for all cases in which the GlideScope was used. The researchers y reviewed and extracted a host of airwayrelated details for each case. They also looked at various other factors, like whether the case involved rapidsequence induction, if the patient was positioned appropriately and if another device was needed to help facilitate the intubation, Dr. Milne said.

The study period covered 76,454 general anesthetics, in which clinicians used a GlideScope in 1,380 adults: 1,005 as a primary device (73%), 110 as a rescue device (8%) and 265 for elective or teaching purposes (19%).

The overall rate of successful intubation with the GlideScope was found to y sixx intubations (4%) were be 94%. Fiftydocumented as “difficult,” whereas 88 (6%) failed. Direct laryngoscopy was the most common rescue technique in the failed cases (52%), followed by bronchoscopy (19%), use of a light wand (16%) and use of a supraglottic

airway device (9%).

Patients who had a failed GlideScope intubation had a median Mallampati score of 3; 20% had decreased mouth opening, 25% had decreased thyromental distance and 31% had decreased neck movement. Practitioners had a good view of the cords (Cormackk Lehane grade 1 or 2) in 26% of failed GlideScope intubations but were nonetheless unable to advance the endotracheal tube through the glottis.

Further analysis of the records found that 120 GlideScope cases were rapidsequence inductions, and patients were ramped in the sniffing position in 54 cases. A bougie was used with the GlideScope in 125 cases.

The researchers also looked at 110 cases in which clinicians used a GlideScope as a rescue device. Of those, 94 were direct laryngoscopies that had failed. “Interestingly, the GlideScope was 100% successful in these cases,” Dr. Milne said.

The data should help anesthesiologists sift through the various video

laryngoscope options currently available, many of which have not been subject to extensive testing or study, Dr. Milne noted. “Many of the new airway devices hit the market without much scrutiny or substantial evidence as to their validity and utility, particularly in the face of difficult airways and emergency situations. So I think we need more in-depth studies on these types of devices.”

D. John Doyle, MD, PhD, professor of anesthesiology at the Cleveland Clinic, Ohio, said the study should help solidify the place of the GlideScope in the anesthesiologist’s airway armamentarium. “The GlideScope is the best-known and most well-studied video laryngoscope,” said Dr. Doyle, a member of the editorial board of Anesthesiology News. “Ten years of clinical experience have shown that it deserves a special place in our airway toolbox, now taking an honorable place beside the fiber-optic bronchoscope as a major innovation in clinical airway management.”

—Michael Vlessides

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26 I AnesthesiologyNews.com

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

CONTINUED FROM PAGE 1

overwhelming majority of patients with PTSD that he has treated.

Dr. Lipovv said the genesis of the therapy came in 2004, when he treated a woman with severe hot flashes who also had complex regional pain syndrome (CRPS).

“My brother, Sergei is an internist, and he hypothesized that since CRPS involves a hot extremity and hot flashes are diffuse, the same treatment—stellate ganglion block—should work for both,” Dr. Lipov said. “And it took away her hot flashes.”

After a similar experience ((Ann Clin Psychiatry 2008;20:227-228), Dr. Lipov and his colleagues decided to further investigate the effects of stellate ganglion blocks on various clusters of PTSD symptoms. They presented their findings as case series at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1310550).

The series comprised eight patients with PTSD, all of whom received one or more stellate ganglion blocks using 0.5% bupivacaine administered with fluoroscopic needle guidance at the C6 cervical vertebrae.

“We have to date treated 65 patients from 22 states,” Dr. Lipovv said. “Other practitioners have treated another 45 in four military institutions. So to the best of my knowledge, at least 100 people have been treated for PTSD with stellate ganglion blocks.”

Approximately 4% of men in the United States, and nearly 10% of women, will experience PTSD in their lifetimes, according to figures from the National Comorbidity Survey Replication. Rates of post-traumaa distress are substantially higher among military veterans; a 2008 survey by the Rand Corporation, for example, found that 13.8% of returning veterans from the most recent wars in Iraq and Afghanistan reported PTSD. In the case series, seven patients were men; five were military veterans. The majority had been prescribed multiple psychotropic medications, with little effect. Most had suffered refractory PTSD for many years.

The mean follow-up time after treatment with stellate ganglion block was 17 days (range: one to 59 days).

Patients who received one block demonstrated statistically significant improvement in symptoms of PTSD related to anxiety. On average, these individuals experienced a 41% decrease in the severity of the disorder (range, 6%-70%). Patients who received two blocks reported greater levels of relief

1. Precipitating event, estrogen decrease, nerve trauma, PTSD triggering event 2. NGF increase 3. Retrograde transport of the NGF

Figure. The possible biologic mechanism for how sympathetic blockade may produce long-lasting systemic effects.

NGF, nerve growth factor; PTSD, post-traumatic stress disorder

than those who received one block. No adverse events were observed.

At the upcoming annual meeting of the American Society of Anesthesiologists, Dr. Lipov will report on the case of a 42-year-old Navy veteran with PTSD who experienced a neartotal turnaround with the block treatment. The sailor had lost his job and was drinking 10 beers a day, Dr. Lipov said, and was experiencing severe memory lapses as a result of his condition.

“We found that after the first block, his memory improved 30%. After the second, it improved 60%. He is now fully employed and off alcohol a year [after] treatment.”

Yet as promising as the therapy may seem, Dr. Lipovv said he does not know precisely how it works. “People think this is a crazy approach to PTSD because it makes no sense for a sympathetic blockade to have a lasting psychiatric effect,” he said. “It sounds absurd.”

However, the benefits of the block for treating PTSD may have a sound biological basis. “When somebody experiences trauma, nerve growth factor (NGF) increases,” he said (Figure 1).

“NGF is carried from the brain to the stellate ganglion, where it produces something called sympathetic sprouting, which in turn produces norepinephrine (Figure 2). And norepinephrine levels have been shown to be chronically increased in PTSD patients.”

Indeed, Dr. Lipovv predicted the effect of the block on PTSD in a 2009 article ((Med Hypotheses 2009;72:657-661).

When a local anesthetic is applied to the stellate ganglion, production of NGF stops, putting an end in turn to the production of norepinephrine (Figure 3).

“Then you’re back to normal,” he said.

Dr. Lipov cautioned against adding steroids to the injectate, as no evidence suggests that the stellate ganglion is inflamed, and steroids increase the patient’s risk for stroke.

With little clinical experience, it is

1. NGF increase in the stellate ganglion 2. Sprouting of the sympathetic fibers distally 3. Increase in the brain norepinephrine

impossible to make assumptions about the widespread efficacy and safety of the approach. Dr. Lipov admitted that 10% to 20% of patients likely will not respond to the block at all, and there are concerns over potential risks with the procedure, including seizure and pneumothorax. A 1992 questionnaire study by Wulf and Maier ( (Anaesthesist t 1992;41:146-151) found 20 adverse events in approximately 45,000 patients receiving stellate ganglion blocks. The incidence of severe complications was found to be 1.7 per 1,000 blocks, most of which involved temporary seizures and other events linked to the central nervous system.

The researchers recorded no permanent damage or fatalities.

‘Major Damage’ Possible Without Expertise “You can do major damage if you don’t know what you are doing because you are right next to the spinal cord,” Dr. Lipovv said. “But the most common side effect is usually a seizure.”

Approaching the stellate ganglion through the C6 rather than the C7 vertebra may help reduce adverse events, he added, because the site is somewhat farther from the lungs and major arteries.

Despite how staunchly Dr. Lipov may believe in the stellate ganglion block as treatment for PTSD, he was cautious about recommending that other anesthesiologists adopt the approach—for now. “If they’re doing it, they should know what they are doing,” he said. “And since anesthesiologists are not well versed in treating psychiatric patients, this kind of treatment should be done in conjunction with a psychologist or psychiatrist because patients still need counseling afterward.”

Nevertheless, the procedure could have a dramatic effect on the national health care landscape. The 2008 Rand study estimated the economic cost— from treatment to lost productivity— of PTSD at between $2 billion and $3 billion per year. “Also keep in mind that current treatments are not particularly effective, and you can see why this is such an important approach,”

1. Stellate ganglion block 2. Reduction of NGF decrease in sprouting, reduction of brain norepinephrine and resolution of symptoms

Dr. Lipovv said. Randomized controlled trials are clearly needed to help shed more light on safety and efficacy.

Dr. Lipovv said the cost to administer the block ranges between $500 and $2,000, depending on the region, type of imaging used and other factors.

Richard W. Rosenquist, MD, chair of pain management at the Cleveland Clinic, in Ohio, said Dr. Lipov’s approach holds promise. “The current data are sufficient to generate interest in moving this forward, but it truly needs to be done in a large, randomized controlled trial with very well-defined outcome criteria if it is going to gain additional credibility,” Dr. Rosenquist said. “It may be a viable treatment option, but it has to be proven to be effective instead of just doing it and hoping that it is effective.

“I think that Dr. Lipovv has done a nice job of outlining both the enormous financial cost of treating these patients with current—and marginally successful—approaches, as well as the potential clinical implications if stellate ganglion block proves successful in PTSD patients,” Dr. Rosenquist continued.

“Yet the dollar amount pales in respect to the personal cost borne by the returning soldiers suffering from this disorder.

I truly hope that a group of interested researchers assembles a strong grant to study this approach to PTSD.” Dr. Lipovv says he first applied for a grant from the Department of Defense in 2007 but was turned down. Rejections in 2009 and 2010 followed. “It was rejected for two primary reasons,” he said. “First, they said I didn’t know why the block worked, even though I had published on it. They also said there are many effective treatments available for PTSD. You can imagine how well I took that answer.”

Dr. Lipov has since turned to other potential funding sources for his research. The state of Illinois has agreed to fund his work, and Dr. Lipov has applied to the National Institute of Mental Health to study PTSD in women who have been victims of sexual abuse.

—Michael Vlessides

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AnesthesiologyNews.com I 29

SEPTEMBER 2012

PR N

For TKA, Shorter Stays Best for Patient, Bottom Line

F

ast-trackingg knee replacement patients leads to overall better outcomes and dramatically reduces costs, new research has found.

As total knee replacement surgeries soar, largely due to the effects of an obesity epidemic and an aging population, interest in finding ways to lower costs and improve patient outcomes is growing. A study comparing the differences in costs, complications and mortality rates among Medicare patients who had differing lengths of stay in the hospital after surgery was presented at the 2012 annual meeting of the American Academy of Orthopaedic Surgeons.

The retrospective study, which looked at more than 100,000 patients, revealed sizable cost reductions in the outpatient and shorter-stayy groups— defined as outpatient to two days— compared with patients who stayed the standard three to four nights, or longer, in the hospital. At 90 days after surgery, patients in the outpatient group reported less pain and stiffness than those who received standard care, but in some cases had a higher risk for mortality, readmission and dislocation, the researchers said.

“There’s a trend in leading hospitals to reduce the length of stay after knee replacement surgery,” said lead researcher Scott Lovald, PhD, MBA, senior associate with Exponent, an

engineering and scientific consulting firm based in Menlo Park, Calif. Exponent often works with medical implant manufacturers, Dr. Lovald said; this particular study was partly financed with a grant from Stryker Orthopedics, a manufacturer of marketed total knee arthroplasty (TKA) systems.

“Clinicians are using more localized anesthesia, and pushing patients to get on their feet and out of the hospital earlier,” Dr. Lovald said. “We wanted to see if changing the length of stay could affect the risk for complications.”

Dr. Lovald and his colleagues reviewed outcomes for the patient groups including annual payments, mortality, readmission, revision and common complications. After adjusting for various factors, the results were compared at 90 days and one and two years after surgery. Dr. Lovald said the study did not address the type or amount of anesthesia used in the surgeries because those data were unavailable.

The outpatient group saved $7,000 per surgery, in costs attributed to the treatment of osteoarthritis two years after the procedure. Compared with the traditional stay (three to four nights) group, the outpatient group saved $3,300 per surgery, whereas the two-dayy group saved $1,700. The last group, five or more days, cost an

JC Urges Safer Use of Opioids in Hospitals

T

he Joint Commission is urging hospitals to take steps to avoid adverse events associated with use of opioids. The focus is on the safe use of opioids in the inpatient setting, although the alert acknowledges that overprescribing and drug abuse also are problematic. The most serious adverse event associated with opioid therapy is respiratory depression, according to the alert; other common effects include dizziness, nausea, vomiting, constipation and sedation (Sentinel Event Alert, t Aug. 8 [Issue 49]).

“We know that opioids are among the top three drug groups in which medication errors occur, and we also know that opioids are among the leading drug groups leading to adverse events,” Ana Pujols McKee, MD, executive vice president and chief medical officer of the Joint Commission, said in an interview. A sentinel event is an adverse event that results in death or permanent loss of function, she said.

The alert provides recommendations on assessment, pain management, hospital policies and procedures, and education and training, as well as tools to screen for risk factors. “One step that would make a big difference is comprehensive assessment before prescribing, in order to gain full knowledge of the patient’s exposure, tolerance and history of previous opioid use. Also, a careful history of medications that may reduce risk for drug interactions.”

The alert calls for routine skin assessments to check if a patient already is wearing a transdermal opioid, involvement by a pharmacist or pain management expert when converting from one opioid to another and other steps to reduce the risk for opioid-related complications.

additional $1,000 per surgery above the standard-stayy group.

“It seems we get much of the cost benefit with patients who stayed only a day, without the higher early mortality rates of the outpatient group,” Dr. Lovald said. “So, judging from this data set, we would probably point to the one-day stay as providing the optimal outcome.”

The five day-plus group experienced the highest costs and hazard risks for mortality, revision and complications.

Dr. Lovald said that although the study controlled for many factors—including baseline health of patients—this group comprised patients who were older and probably less healthy before the procedure than the other patient groups.

Asokumar Buvanendran, MD, professor of anesthesiology at Rush University Medical Center in Chicago, said the study illustrates what he has learned from experience: Fast-tracking patients is definitely beneficial, resulting in lower costs and better overall outcomes.

“We have been discharging healthy patients the same day after TKA surgery for a decade,” Dr. Buvanendran said. “What we need now is a large, randomized, prospective study because the future is continuing to move toward minimally invasive procedures and early discharge.”

Dr. Lovald agreed, and said his team’s study is interesting in part because it differs from the research conducted at advanced institutions where they have already “worked out the bugs.” He incorporated all institutions in the Medicare database in his study, including those just beginning shorter-stay protocols. “The slightly higher revision and mortality rates at 90 days that we observed in some of the shorter-stayy groups may just reflect the awkward growing pains of new programs,” Dr. Lovald said. “Our study supports the recommendation of previous studies that shorter-stayy protocols be implemented gradually.”

—Dana Hawkins-Simons

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30 I AnesthesiologyNews.com

SEPTEMBER 2012

PRN BLACK HOLE

CONTINUED FROM PAGE 1

from the previous system, which employed per-case drug trays, said Jenna Smith, CPhT, an OR pharmacy technician who helped spearhead the technology upgrade. “Too often, the trays didn’t contain a drug that was needed during the case, and so the case might be interrupted while a nurse or the anesthesiologist left the OR to get the medications from a dispensing unit down the hall,” Ms. Smith said. “That was a time-wasterr and source of frustration for the entire OR team.”

The drug trays posed another problem: frequent mismatches between what the paper-based anesthesia record would say was used during the case and what was left in the tray. “Jenna would have to piece together why the mismatches were occurring,” Mr. Speth said. “If it was a narcotics discrepancy, she would have to chase down the anesthesiologist and say, ‘you took out a narcotic but it wasn’t logged into the anesthesia record.’ He’d usually acknowledge it was an oversight—he forgot to record it, rather than it being [due to drug] diversion—so it wasn’t adversarial. But it was a drain on Jenna’s time because not only did she have to resolve the discrepancy, she then had to manually charge those items so that we got reimbursed for the medications.”

Once the ADCs were in place, several improvements ensued: The number of controlled substance discrepancies fell from 10 per week pre-implementation to one per week, and the time required to resolve those discrepancies was cut from five to two hours per week, Mr. Speth reported.

Because the carts generate charges for reimbursement when drugs are dispensed, he added, the one to two hours per day devoted to charge reconciliation was eliminated. Restocking time was reduced from three to four hours per day to 1.5 hours per day.

Mr. Speth added that the ADCs also improved medication safety, although those outcomes were Advertisement

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harder to document. For example, during the medication dispensing process, the cart’s computer screen lists the selected drug, “which is probably safer than selecting drugs from an open tray,” he said. The monitor also displays the concentration and amount of each drug stored in the cart, further aiding accurate dispensing and administration. The system also prints a color-coded label for each drug dispensed, which then can be affixed to the syringe after drawing up the dose—a feature “that really helps prevent medication mixx ups,” Mr. Speth said.

But simply citing outcomes data, hard or soft, tells only part of the story, he stressed. “You really need to see this from the perspective of the anesthesiologists.

When they realized the ADC would give them immediate access to five or 10 or even 20 vials of each drug in the OR—at the patient’s bedside—it was viewed as a major improvement over the per-case trays.”

Anesthesiologist a Fan Layne Tait, MD, a staff anesthesiologist at IUHB f described “crash-test dummies” and one of the selfwho helped roll out the ADC system, agreed that ready access to virtually all of the medications one could need during a procedure was by far the system’s major benefit. “It’s all there right at your fingertips,” Dr. Tait said. “There’s hardly anything you need to get from the pharmacy, other than an occasional antibiotic.”

He also underscored the safety gains that come when nurses no longer have to leave the OR to retrieve medications not included in per-case drug trays. “If nurses are in the OR, I need them to stay in the OR—they’re important members of the surgical team. I certainly don’t want them scrambling around to find meds during a critical situation.”

As for the system’s potential for reducing drug diversion, Dr. Tait and Mr. Speth both pointed out that it should make it harder for users to divert narcotics because it takes nurses out of the dispensing loop and produces a record of dispensed drugs that can be audited against the anesthesia record. “It certainly isn’t foolproof, however,” Mr. Speth noted.

Asked if there are any flaws to the ADC technology, Dr. Tait cited the cabinet’s keypad response.

“Sometimes you have to hit it two or three times before it responds to a command,” he said. “In this era of instant response from smart phones and tablets, the delay is noticeable.”

Preeti Churbock, portfolio manager at McKesson’s Automation Solutions division, said the latest version of the software in the company’s Anesthesia-Rx carts used at IUHB minimizes the need for a keypad.

“Users wanted a quick way to remove the medication with a simple barcode scan, so we developed this functionality,” Ms. Churbockk said.

although I understand that wasn’t an issue at IUHB. Still, anything you can do to minimize the risk for diversion or eliminate conditions where it can occur is an impressive accomplishment.”

Mr. Chernin added that he discussed implementing OR ADCs with his own anesthesiologists but met some resistance. “The most common pushback I got was a fear that the drawers or the carts would fail, and that as a result, the anesthesiologists would not be able to access the needed agents, either during the normal course of the case, or worse, during a medical emergency.”

Mr. Speth said the ADCs at IUHB “have been reliable, considering their heavy use and abuse.” However, he conceded that some breakdowns have occurred. “My IT team tells me that we have had about three PC failures and one drawer failure in a little more than 18 months,” he said. “PC failure is normal and can be replaced in a couple hours by our people. The drawer failure was due to user abuse and took about the same time to fix. But at no time were drugs inaccessible to OR physicians; we have a multilevel backup plan in place.”

That plan includes cart keys that are stored in a dispensing cabinet in the hallway, which can be accessed if the bedside cart in the OR locks up—an option “that we have not yet needed,” Mr. Speth stressed; using another cart from an idle room; getting the needed medication from a per-case tray left over from the hospital’s previous drug dispensing system; and “if all else fails,” obtaining medications from the pharmacy.

A Tip for Vendor Selection Mr. Speth stressed that vendor selection is key when evaluating ADC systems. He cautioned, however, against focusing solely on the bits and bytes of the rollout process. “You have to start with the human element and get all of the stakeholders—particularly anesthesiologists—on board. Try to justify the program based on how it will benefit users in the OR. For my anesthesiologists, the most important benefit was rapid access to medications at the patient’s bedside. Once they realized they would have that, they really bought into the system.”

New technology can be an expensive proposition. If administrators push back due to cost, Mr. Speth said, make a case for ADCs based on return on investment (ROI). Although total charge capture did not increase at IUHB, the process was quicker, saving staff time.

For many hospitals, charges often are missed, he noted. In such cases, “you can [point out] that the increased reimbursement you’re going to achieve with this system will give you a very rapid ROI—this is truly money well spent.”

And if hospital management still won’t budge, it may be time to cite Joint Commission requirements for storing medications in a secure manner, Mr. Speth said. “No unauthorized staff can have access to medi‘Horrendous Knot’ Untangled Eric Chernin, RPh, a pharmaceutical care special- cations, and controlled substances must be doubleist in the OR pharmacy at Sarasota Memorial Hos- locked,” he explained. “The Anesthesia-Rx carts pital, in Florida, said the IUHB approach “is great, accomplish both; cart access is password-controlled given the fact that they don’t have an OR pharmacy and controlled substances are stored in individually to monitor anesthesia drug use.” Mr. Chernin said locked and lidded pockets that allow access only to the he was particularly impressed by the reduced time item selected on the screen. So this is at least one item required to resolve narcotic discrepancies, which you don’t have to worry about during a field survey.” “can be a horrendous knot to untangle. Nobody wants them, and they may signal narcotics diversion, —David Bronstein

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