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Perioperative Red Tape: Streamlining Workflow
Success of Spinal Lower for turients
Christine Doyle, MD
A
sk 100 physicians—whether suurgeons, anesthesiologists or other MDs—to name their favorite part of practicing medicine, and not one would cite rred tape or paperwork. These requirements pllay an important role, however, so often theyy’re considered a necessary evil. In recent years, regulatory and quallity measures have grown exponentially, increasing in both number andd complexity. HIPAA, Surgical Quaality Improvement Project (or SCIP), an nd
New Orleans—A review of o more than 5,000 patient records has concluded that women undergoing preterm cesarean delivery have a signiificantly higher risk for failed spinal anesthesia than womeen undergoing the procedure at full term. These findingss, reported by a Duke University research team at the 2014 annual meeting of the American Society of Aneesthesiologists, suggest that an increased spinal dose—oor combined spinal–epidural technique—may be neceessary to reliably ensure adequate anesthesia in this poopulation. Although studies have examined the relative spread of spinal block for surgicaal anesthesia in pregnant and
see red tape e page 26
see preterm spinal page 5
MOCA Push-Back
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Who controls certification? In 2000, the American Board of Anesthesiology (ABA) Robert E. Johnstone, MD changed its process, making new our decades ago, board certification was a mark certificates temporary, good for of excellence, a goal for achievers and not a 10 years only, and developed practice requirement. Certification designated requirements and fees to renew an anesthesiologist with consultant-level knowl- them. Other organizations, pri- Robert E. Johnstone, MD edge and extraordinary capabilities. But times have marily the American Society of Anesthesiologists, develchanged. Many institutions and groups now require oped products and programs that anesthesiologists could certification for clinician credentialing. No certifica- buy to meet these requirements. The laudable goals tion increasingly means practicing at small hospitals included lifelong professional development for clinicians, in temporary positions. see MOCA page 27
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ffor iPad 2014 The Top 10 Articles of 2014 on AnesthesiologyNews.com see page 4
CLINICAL ANESTHESIOLOGY
Perioperative risk factors mapped for noncardiac surgery patients >80 years
see pages 4 and 17
REPORT Enhanced Recovery Pathways for Major Abdominal Surgery see insert at page 16
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CLINICAL ANESTHESIOLOGY
NAP5 finds accidental awareness cases most often involve a neuromuscular block
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PAIN MEDICINE
Study sheds light on link between primary and referred pain
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PRN
The history of the development of blood transfusion
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COMMENTARY
Electronic devices act as vectors of infection in today’s wired world
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April 17-19, 2015
The Cosmopolitan of Las Vegas Topics Featured at the 2015 Advanced Institute for Anesthesia Practice Management As a busy professional you realize it’s imperative to keep informed on the latest topics of interest to Anesthesiologists, Practice Administrators, CRNAs and others in the anesthesia marketplace.
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The Advanced Institute for Anesthesia Practice Management, to be held April 17-19, 2015 at The Cosmopolitan of Las Vegas, offers a chance to experience the following topics, led by industry-renown experts. The Value of Leadership During Change Is Your Anesthesia Group a Business or Club? Coding and Billing for Postoperative Pain Doesn’t Have to Hurt The Rapidly Changing Anesthesia Landscape Getting Anesthesia Providers On Board With Compliance Impact of the 2015 CPT/ICD-10 Protecting Your Patient Data Staying On the Right Side of Compliance The Anesthesiologist’s Role in the Perioperative Surgical Home 2015 PQRS for Pain Management The AIAPM conference also includes numerous talks on anesthesia and pain billing and coding, charge capture and compliance. Please join us for an informative meeting and exceptional educational experience.
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CLINICAL ANESTHESIOLOGY PRETERM SPINAL
CONTINUED FROM PAGE 1
nonpregnant women, only limited research has been conducted on spinal dosing for preterm and term parturients. “The purpose of the study was to investigate the hypothesis that preterm gestation may be associated with an increased incidence in failures of spinal anesthetics compared to those patients who were at term gestation,” said Lisa M. Einhorn, MD, a resident at Duke University Medical Center, in Durham, N.C. To help answer that question, Dr. Einhorn and her colleagues searched their institution’s database for women who underwent cesarean delivery under spinal or combined spinal– epidural anesthesia between 2003 and 2012. Patients were included if their height was 152 to 183 cm, and they received standard doses of local anesthetic (0.75% hyperbaric bupivacaine ≥10.5 mg with fentanyl 15 mcg and morphine 0.1-0.2 mg). “Our primary outcome was inadequate surgical anesthesia or failure after an initial spinal dose,” Dr. Einhorn said (abstract A1059). Failure was defined in several ways: the need to repeat the Table 1. Odds of Failure Using Adjusted Multivariable Linear Regression Model
Covariable
Adjusted Odds Ratio (95% confidence interval)
P Value
GA (wk)
0.91 (0.88-0.94)
<0.0001
Age (y)
1.01 (0.98-1.03)
0.69
Height (cm)
1.01 (0.99-1.04)
0.32
Weight (kg)
1.00 (0.99-1.01)
0.84
Bupivacaine (mg)
0.95 (0.74-1.23)
0.72
Race White
1.00 (reference)
Black
1.21 (0.82-1.77)
0.33
Hispanic
1.14 (0.67-1.92)
0.63
Asian
0.68 (0.24-1.91)
0.46
Other
0.001 (<0.001 to >999)
0.99
GA, gestational g age g
spinal technique to obtain adequate block height; conversion to general anesthesia secondary to pain; supplementation with IV analgesics; the use of nitrous oxide; or augmentation of the initial block with epidural lidocaine within 30 minutes if a combined spinal–epidural technique was used. A total of 5,041 women were included in the analysis; 3,404 pregnancies were term and 1,637 were
preterm. The groups were similar in demographics and hyperbaric bupivacaine dose; the most common bupivacaine dose was 12 mg, which 62% of patients received. The investigators found that of 150 failed spinal anesthetics (3.2%), significantly more cases occurred in preterm women (4.5%) than term (2.2%; P<0.0001). “Those that are earliest preterm—less than 30 weeks—had the
highest level of failure [6.8% vs. 3.6% for those with <37 weeks gestation],” Dr. Einhorn said. A multivariable regression model revealed that gestational age was a significant predictor of anesthetic failure (adjusted odds ratio, 0.91; P<0.0001). No other factor—age, race, height, weight, bupivacaine dose—was statistically significant (Tables 1 and 2). see preterm spinal page 6
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CLINICAL ANESTHESIOLOGY PRETERM SPINAL
Table 2. Odds of Failure Using Adjusted Multivariable Logistic Regression Modela
CONTINUED FROM PAGE 5
“Our thoughts behind this are that pregnant patients are known to need higher doses of local anesthetic to create the same block heights,” Dr. Einhorn said. “So it’s possible that these early preterm patients may not fully undergo the anatomic and physiologic changes that lead to increased spinal spread in pregnancy. Therefore, an increased spinal dose may be necessary to fully anesthetize these patients
for surgical anesthesia for cesarean delivery,” she added. “We would recommend a combined spinal–epidural technique, which would allow for the augmentation of the initial spinal in these patients, if needed.” Richard M. Smiley, MD, PhD, Virginia Apgar Professor of Anesthesiology and chief of obstetric anesthesia at Columbia University Medical Center, New York City, noted that these
data are consistent with previous research. “It’s very similar to what you see if you look at postpartum bilateral tubal ligation, because once again, the anatomy has changed. But my clinical conclusion would not be to do a combined spinal–epidural,” Dr. Smileyy said. “My preference would be to just give everyone 15 mg. It’s simpler and safe enough.” An ancillary study by the same
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GA (wk)
Adjusted Odds Ratio (95% confidence interval)
P Value
≥37
1.00 (reference)
>30 and <37
1.59 (1.08-2.35)
0.02
≤30
3.07 (2.00-4.73)
<0.0001
GA, gestational age a
Same predictors tested in the linear regression model were also found not to be statisticallyy significant g in th this his model.
JANUARY 2015
AnesthesiologyNews.com I 7
CLINICAL ANESTHESIOLOGY research team (abstract A1061) examined the incidence of high blocks and failed blocks in patients who received spinal block for cesarean delivery after an inadequate labor epidural. Using the same study cohort, the investigators divided the patients into two groups by whether they received or did not receive a top-up dose (epidural lidocaine â&#x2030;Ľ100 mg) before spinal administration. There were 29 failed spinals (11%) and nine high spinals (3%). Interestingly, the incidence of failed spinals was
significantly greater in patients who received an epidural top-up (24% vs. 4%; P<0.001). This, the researchers hypothesized, may be partly due to the presence of a large volume of local anesthetic in the epidural space, which may be mistaken for cerebrospinal fluid. Multivariate regression analysis revealed that the topup dose was a significant predictor of block failure (P=0.0005).
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CLINICAL ANESTHESIOLOGY
Continuous Femoral Nerve Block Best for TKA Analgesia
A
meta-analysis confirms that a continuous femoral nerve block (FNB) produces longer-lasting pain relief than a single-injection block after total knee arthroplasty (TKA). The findings were presented at the 2014 World Congress on Pain, in Buenos Aires, Argentina (poster PH004). These results were also published earlier this year as part of a Cochrane
Review analyzing the effectiveness of FNBs in reducing acute pain after TKA (Cochrane Database Syst Rev 2014;5:CD009941). The authors determined that patients had statistically significantly lower levels of pain at rest and pain on movement 24 and 48 hours after analgesia for continuous compared with single-injection block.
The comparison made by the team involved four randomized controlled trials, in which a total of 272 patients undergoing TKA were enrolled (Reg Anesth 1996;21:292-297; Anesth Analgg 2006;102:1234-1239; Korean J Anesthesioll 2010;58:468-476; and J Arthroplasty 2013;28:608-613). The researchers found that each of the four studies had somewhat different
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methodologies, including patient selection, and some risk for bias. The researchers converted the pain outcomes to a scale from zero to 10. The summary statistic used for the analysis was mean differences (MD), whereas the Cochrane review used the standardized mean differences (SMD). “MD is a more intuitively understandable summary statistic for clinicians,” noted Ee-Yuee Chan, PhD, the lead author of the poster and the Cochrane review, as well as the 2013 paper that was one of the four included in the meta-analysis. Dr. Chan participated in the review while she was completing her PhD degree at the Faculty of Health Sciences, University of Sydney, Australia, and is now senior nurse researcher, Tan Tock Seng Hospital, in Singapore. The analysis showed high heterogeneity between studies with respect to measurement of pain at rest at 24 hours (I2 = 77%), but nonetheless the mean difference in pain at rest at 24 hours between continuous and singleshot FNB was statistically significant at –1.00 (95% confidence interval [CI], –1.90 to –0.10). This represents a mean 1-point greater reduction in pain for continuous versus singleinjection FNBs. The heterogeneity between the four studies with respect to measurement of pain on movement at 24 hours was low (I2 = 19%) and the mean difference was again significant, with a value of –0.89 (95% CI, –1.43 to –0.36). This represents a mean 0.89-point greater reduction in pain. see nerve block page 13
JANUARY 2015
AnesthesiologyNews.com I 9
CLINICAL ANESTHESIOLOGY
Noncardiac Perioperative Risk Factors in Elderly Mapped New Orleans—Patients older than 80 years have been found to do well after noncardiac surgery, with surprisingly few complications, according to a study from Japan. However, there are several factors that predict postoperative adverse events, including preoperative hypoalbuminemia, intraoperative blood transfusion, longer operative time and male gender. “The average life span has been rapidly increasing around the world,” commented Yoshinori Muto, MD, a senior resident at the University of Tokyo Hospital, in Japan. “Meanwhile, the volume of surgery for the elderly has also increased. As such, the aim of this study was to investigate the perioperative risk factors that predict 30-dayy postoperative complications in elderly patients who undergo noncardiac surgery.”
The 334 patients had a mean age of 82.9 years; slightly more than half (51.2%) were men. Abdominal surgery was performed in 121 patients (36.2%). “The most common comorbidity we found was moderate or severe renal disease, followed by tumor without metastasis,” Dr. Muto said in an interview with Anesthesiology News. The mean CCI score was 3.6, he added.
As Dr. Muto reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A1240), 30-day postoperative complications occurred in 91 patients (27.2%), including one death. Multiple logistic regression analysis revealed that four factors were associated with the development of postoperative complications: preoperative
serum albumin concentration <3.5 g/mL (odds ratio [OR], 2.65; 95% confidence interval [CI], 1.53-4.61; P<0.001); intraoperative blood transfusion (OR, 4.45; 95% CI, 1.96-10.10; P<0.001); operative time ≥120 minutes (OR, 3.11; 95% CI, 1.68-5.74; P<0.001) and male gender (OR, 1.97; 95% CI, 1.15-3.37; P=0.014). see elderly page 13
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Dr. Muto and his colleagues identified 334 patients at least 80 years of age, who underwent noncardiac surgery under general anesthesia at his institution between January and December 2013. Several preoperative and intraoperative variables were recorded, including demographic data, anesthetic management, type of surgery, and preoperative comorbidities using the Charlson Comorbidity Index (CCI) score. The primary composite outcome was 30-dayy postoperative complications, including death, cardiac adverse events (heart failure, ischemic heart disease or atrial fibrillation), pneumonia and other infections, cerebrovascular disease and deep venous thrombosis/pulmonary embolism.
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CLINICAL ANESTHESIOLOGY
Elderly Patients Often Receive Too Much Anesthesia for Endoscopy New Orleans—Elderly patients undergoing ambulatory gastrointestinal procedures often receive inappropriately high doses of anesthesia at induction, researchers have found. The study, a review of the anesthetic management of patients undergoing
upper endoscopy and colonoscopy at Yale School of Medicine, in New Haven, Conn., found that even with age-adjustedd dosing, significant drops in mean arterial pressure occur. “The elderly population may be more susceptible to adverse events from
anesthesia, such as hypotension, given the cardiovascular, pharmacokinetic and pharmacodynamics changes associated with aging,” said Vicki Bing, BS, a medical student at Yale who helped conduct the study. “So it is recommended that anesthetic dose be adjusted for age. It’s
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been unclear, however, whether current practices adequately correct dosing for increasing age.” Ms. Bing’s group reported their finding at the 2014 annual meeting of the American Society of Anesthesiologists (ASA; abstract 3164). Ms. Bingg and her colleagues sought to determine whether induction anesthetics are dose-adjusted for age and, if they are, if this results in increased hypotension. They examined the anesthesia records of 799 adults who underwent nonemergent, ambulatory gastrointestinal procedures at Yale over a sixx week period in 2013. They recorded induction doses of propofol and fentanyl, and looked for changes in mean arterial pressure (MAP) within 10 minutes of induction. Anesthetic doses and changes in MAP were compared across age groups (the oldest group aged ≥80 years) and across ASA classes 1 to 4, which indicate severity of illness. No Adjustment in Fentanyl Dosing for Age The researchers found there was no difference in fentanyl dosing between age groups, indicating that this anesthetic’s dose is not being reduced appropriately for elderly patients. Interestingly, mean fentanyl dose increased with increasing ASA class (P=0.03). Propofol dosage, in contrast, was significantly different across age groups (P<0.01), with older patients (≥65 years) receiving less drug than younger (<65) patients. An exception was patients in ASA classes 1 and 2, in which propofol dosage did not differ between young and old patients. Notably, despite the fact that older patients received lower propofol doses, patients aged 65 and older experienced significantly greater drops in MAP (Table). “Our take-home point is that propofol dosing is not appropriately adjusted for age and for ASA classes 1 and 2, and with propofol dose adjustments, MAP changes are still significant in older patients,” Ms. Bingg said.
JANUARY 2015
AnesthesiologyNews.com I 11
CLINICAL ANESTHESIOLOGY Table. Mean Anesthetic Doses and MAP Changes by Age Patient Group
Fentanyl, mcg/kg
Propofol, mg/kg
Change in MAP, mm Hg
All: Young vs. old
0.10 vs. 0.09
2.02 vs. 1.71
–8.39 vs. –13.73
ASA class 1 and 2: Young vs. old
0.08 vs. 0.06
2.08 vs. 2.00
–7.54 vs. –12.97
ASA class 3 and 4: Young vs. old
0.12 vs. 0.10
1.96 vs. 1.55
–9.35 vs. –14.15
will have some patients slipping too low and some being awake.” Dr. Goudra added that he would like to see brain function monitoring be part of training clinicians to measure the depth of sedation. “It’s very difficult to learn dosing. It’s very provider-dependent,” he said. —Caroline Helwick
MAP,, mean ea aarterial te a ppressure essu e
Contact the editor of Anesthesiology News
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Shamsuddin Akhtar, MD, associate “You need a very observant clinician,” Ms. Bing, and Drs. Akhtar and Goudra reported no professor of anesthesia at Yale School he added. “No matter what you do, you relevant financial conflicts of interest. of Medicine and senior author of the study, said the findings show that anesthesia providers are more likely to adjust dosing by ASA class than by age. “Sicker patients get a little less anesthetic,” Dr. Akhtarr said. The researchers’ next step, he said, LMA is to delve into the pharmacodynam® ics data for the oldest age group, which is an area not well understood. He Laryngo-Tracheal Mucosal believes they will find that MAP reductions are even greater in that subset. Atomization Device As for recommendations, Dr. Akhtar said, “We think there are opportunities to decrease the dose, and [clinicians] should not only be looking at ASA class but also age. There’s more room for reducing the dose in the elderly, especially patients above age 80.” “We know the elderly lack the cardiac, respiratory and renal reserves that younger patients have,” he explained. “Significant drops in MAP can result in end-organ damage, but they also trigger therapeutic interventions with vasopressors, fluids and so forth that can have negative consequences in patients with minimal reserves. Prevention of these scenarios is better than cure.” Seeking a solution to replace the Hospira® LTA™ 360 Kit? Basavana Goudra, MD, assistant professor of anesthesiology and critical care Consider using the LMA® MADgic® Device for your anesthesia needs. medicine at the Hospital of the University of Pennsylvania, in Philadelphia, A versatile choice to administer medica ation n across the e entire up ppe per ai airw r ay rw y and d bey eyon o d on said, “Almost 80% of my work is for gas® ® the vocal cords, the LMA MADgic De evice fr f om Telefl flex is ideal fo for alll of o you ourr di d ffi fficu ficu ult and n trointestinal procedures, so I do these sedations frequently. I have found that awake intubations, bronchoscopies, tra ranseso opha h geal ecchoccardiog gra rams ms and end n os osco c pi co p es es. optimal dosing goes far beyond just age and ASA classification. It’s more an art ation and d ex exac a t With the LMA® MADgic® Device you can selecct the type of medica than a science,” Dr. Goudraa said in an dosing desired. And with its malleab ble stylet, you can atttain n precisse deliive ery tha h t’s interview. specific to your patient’s anatomy. Anesthetic pharmacokinetics and pharmacodynamics are extremely variy to help you to deliver The LMA® MADgic® Device is ready able among patients, he pointed out. LMA “With older patients, we typically start targeted, thorough topical anesthe etic for your difffi ficcult intub batio on MADgic with low doses, but having said that, I Laryngo-Tracheal Mucosal and extubation cases. For more in nformation contact ct your once sedated a 104-year-old patient Atomization Device Teleflex representative or visit LM MAMADgic.com. for colonoscopy,” Dr. Akhtar said. “I ended up dosing her almost as much as a 50-year-old. If I administer propofol LMAMADgic.COM *For use with drugs approved for oropharyngeal delivery. to maintain a plasma concentration of 2 Hospira and LTA are trademarks or registered trademarks off Hospira, Inc. mcg per cc in 100 patients, the response Teleflex, LMA, MAD and MADgic are trademarks or registerred trademarks of Teleflex In ncorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-0007 742 could range from awake to deep general anesthesia, depending on the brain response of the given patient. ®
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Study Clears Gum Chewing Before Endoscopy New Orleans—Patients who are fasting before upper endoscopy can safely chew gum up until the time of the procedure, researchers have found. Guidelines on preoperative fasting from the American Society of Anesthesiologists do not explicitly address gum chewing. However, many anesthesia departments prohibit sedation in such patients because gum chewing is
considered the ingestion of a clear liquid. As a result, many patients end up having procedures delayed or cancelled when they report having chewed gum— unnecessarily, the new data suggest. “The effect of chewing gum on fasting has been a subject of debate. We found that although chewing gum does increase the production of saliva and thus the residual gastric volume,
it does not increase pH,” said Basavana Goudra, MD, assistant professor of anesthesiology and critical care medicine at the Hospital of the University of Pennsylvania, in Philadelphia, who led the study. “We think that gum chewing before a procedure may help to allay anxiety in patients and increase their comfort and satisfaction. Patients should not who have chewed gum inadvertently face delays or cancellations.” The findings were presented at the 2014 annual meeting of the American Society of Anesthesiologists (ASA) by Augustus Carlin, a clinical research assistant to Dr. Goudra and a student at Drexel University, in Philadelphia. The study appeared in the journal Digestive Diseases and Sciences (Nov. 2). The prospective randomized controlled study evaluated the effect of gum chewing on volume and pH of gastric contents in 67 patients scheduled to receive IV conscious sedation for upper endoscopy. The night before the procedure, patients were randomly assigned to chew gum until the start of sedation—using fentanyl, midazolam ® and occasionally diphenhydramine— 5 Day Days ys or to not chew gum, with no limit on the number of pieces or how long they could chew. 4 Day Days “The aim was to reflect real-life gumchewingg habits,” Mr. Carlin said. EXPAREL has been promoted as providing pain control that lasts for up to 72 After insertion of the endoscope, hours without the need for catheters and pumps.1 Sound too good to be true? It is. stomach contents were suctioned com3 Da Days pletely under direct vision and the volIn fact, based on further analysis of the data,4 after 12 hours there was minimal ume and pH of stomach contents were to no difference between EXPAREL and placebo (normal saline) treatments on measured. 2D Da ays ys mean pain intensity as demonstrated in their two pivotal studies.2-3 “We found a significant difference in gastric volume,” Mr. Carlin reported. “However, the increase in residual volume was smaller than what 1D Da ay we expected and therefore it failed to 12 1 2 Hour ours ou o u urs urrs rs EXPAREL’s studies only demonstrate 12 hours of pain relief.2-4 achieve clinical significance that would alter practice.” The median volume suctioned from the gum chewers was 13 mL, compared with 6 mL for non–gum chewers. SimShed light on the facts about using EXPAREL® and download studies ilarly, gastric fluid also was greater for at factvsfiction.info, or call 1-800-448-3569 for more information. gum chewers—0.35 versus 0.11 mL/ kg for patients who did not chew gum. ON-Q*: Effective post-op pain management. “The 0.35 mL/kg is still under 0.4 mL/ kg, which is where the risk for aspiraFor over 3.5 million patients and counting. tion comes into effect,” he noted. 4 Controllable. Long-lasting. Proven. The mean pH value was 2.84 for gum chewers and 3.79 for non–gum chewers, a difference that did not reach statistical significance (P=0.141). you more co costs “There was little to no change, and ut Every day without therefore no increased risk [for aspiraFORMERLY I-FLOW, LLC AND KIMBERLY-CLARK tion],” Mr. Carlin said. Anthony Absalom, MD, profesThere are inherent risks in all medical devices. Please refer to the product labeling for Indications, Cautions, Warnings, and Contraindications. Failure to follow the product labeling could directly impact patient safety. Physician is responsible for prescribing and administering medications per sor of anesthesia at University Medical instructions provided by the drug manufacturer. Refer to www.halyardhealth.com for product safety Technical Bulletins. Center Groningen, in the Netherlands,
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EXPAREL. Advertisement. Outpatient Surgery1 Nov. 2013:57-58. Print. 2 Golf M, Daniels SE, Onel E. A Phase III, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. Sep 2011;28(9):776-788. 3 Gorfine SR, Onel E, Patou G, et al. Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled trial. Dis Colon Rectum. Dec. 2011;54(12):1552-1559. 4 Data on File.
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CLINICAL ANESTHESIOLOGY NERVE BLOCK
ELDERLY
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Significant differences were also seen at 48 hours, with mean differences of –1.41 (95% CI, –2.63 to –0.20) and –1.12 (95% CI, –2.04 to –0.21) for pain at rest and pain on movement, respectively. Continuous FNB also was associated with less opioid use than single-shot FNB at 24 and 48 hours. Stavros Memtsoudis, MD, PhD, clinical professor of anesthesiology and public health, Weill Cornell Medical College, in New York City, who was not involved in the study, was contacted by Anesthesiology News for comment. Dr. Memtsoudis said the findings are not surprising because single injections tend to wear off in 24 to 48 hours. He also said it remains to be seen whether recently available long-actingg local anesthetic formulations will be approved for perineural use to prolong the action of single-shot blocks. “But one also has to consider the potential downsides of prolonged catheter-driven peripheral nerve block [PNB]. Some have suggested it may increase fall risk,” Dr. Memtsoudis said. “Thus, the use of catheter assistance [which is required for continuous analgesia with PNBs] has to be judged in terms of risks and benefits, like everything we do in medicine.” —Rosemary Frei, MSc Drs. Chan and Memtsoudis did not report any relevant conflicts of interest.
said concerns about gum chewing are based on fears that the regurgitation of gastric contents into an unprotected airway will damage the lungs, and the degree of potential damage is related to the volume, nature and pH of the contents. Lower pH equates to more acid and potentially more damage, he said. “Although the study found that gum chewing causes a slight increase in gastric volume, this was clinically insignificant and insufficient for causing lung injury if aspirated into the lungs. The pH also did not change,” Dr. Absalom noted. “All said, the study showed no evidence that gum chewing during fasting is bad; and on this basis, I personally would not delay anesthesia because a patient chewed gum while fasting.” —Caroline Helwick
“We found it surprising that hypoalbuminemia was a predicting factor for postoperative complications, whereas age and Charlson Comorbidity score were not, because there are so many reports that preoperative performance status is a predicting factor,” Dr. Muto said. “This may mean that nutritional condition was more important in the
acute postoperative phase in elderly patients than age or preoperative comorbidities. “Secondly, transfusion during surgery and longer operation time were identified as predicting factors,” he added. “This indicates that operative stress that requires intraoperative transfusion is more important than preoperative anemia. These results may help predict postoperative outcomes, but further research is also required to evaluate other factors.”
Gwendolyn L. Boyd, MD, professor and medical director of anesthesiology at the University of Alabama at Birmingham, lauded the researchers for their efforts. Indeed, she noted the importance of the study for a variety of health care specialists. “This topic is an important one for anesthesiologists, surgeons and health care policy makers to know about,” she told Anesthesiology News. —Michael Vlessides
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NAP5 Identifies Susceptibilities in Accidental Awareness Cases
I
n nearly all cases in which patients suffered accidental awareness during general anesthesia, a neuromuscular block (NMB) was also given, despite NMBs being routinely used less than half the time when anesthesia is administered. So concluded the largest and most comprehensive study of accidental awareness to date. Of the patients who reported accidental awareness, 93% involved an NMB, according to the report, which was commissioned and funded by the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland. The study was published in the British Journal of Anaesthesia (2014;113:549-559). That is almost double the rate of NMB use in the 2.8 million cases of general anesthesia examined by the study, with an NMB administered 46% of the time in hospitals in the United Kingdom and the Republic of Ireland, according to the 5th National Audit Project on Accidental Awareness (NAP5). The likelihood of accidental awareness during general anesthesia (AAGA) also rose dramatically during cesarean deliveries and in patients undergoing cardiac or thoracic surgery compared with other procedures. The majority of cases occurred during induction and emergence from anesthesia, not in the middle of surgery, as previous studies have suggested. The study, the most exhaustive examination of AAGA to date, also raises questions about how accidental awareness is currently identified and studied, finding a much lower number than previously estimated—one in 19,000 cases compared with one in 600 cases in surveys that have used the so-called Brice methodology. The number of cases examined was much larger than previous prospective studies, most of which examined a score of cases or less. “We have been able to bore down into the themes that emerge from these cases,” said Professor Tim M. Cook, consultant in anesthesia and intensive care medicine, Royal United Hospital NHS Trust, Bath, one of the authors of the report. The study looked at 300 cases in which patients reported AAGA between June 1, 2012 and May 31, 2013. The NAP5 researchers narrowed that number to 141 certain/probable or possible cases. Nearly two-thirds, or 65% of the cases, involved women, whereas obese patients were three times more likely to experience accidental awareness. Young and middle-aged adults were statistically overrepresented, whereas the elderly and children were underrepresented. Two-thirds of the cases examined by the study involved accidental awareness during either the induction of anesthesia (47%) or emergence from it (18%), with 34% occurring during the maintenance phase. This was a major break from past reports and studies, which have suggested that most cases of accidental awareness took place during the maintenance phase. One subgroup of patients, women undergoing cesarean deliveries, seemed particularly prone to accidental awareness, with an incidence of one in 670. Cardiothoracic anesthesia patients also had a high rate of reports, at one in 8,600.
The study points to several potential risk factors for AAGA, with cases of general anesthesia given during cesarean deliveries combining with a number of them. One of the most striking findings, however, was the tie between the use of NMB and reports of AAGA. Patients receiving an NMB were 16 times more likely to suffer AAGA than those who also reported awareness but did not receive an NMB, the report stated. For patients who received an NMB, the incidence of reports of accidental awareness rose to one in 8,200 (range, one in 7,030-9,700). That’s compared with one in 135,900 (range, one in 78,600-299,000) for patients who reported AAGA but did not receive an NMB. The cases of AAGA involving an NMB also were more likely to be particularly traumatic, with patients awake but unable to move, creating confusion and a feeling of paralysis, said Professor Jaideep Pandit, consultant anesthetist at the Oxford University Hospitals, in the United Kingdom, who is one of the authors of the report. Of these patients, 52% experienced distress and 42% went on to suffer longer-term psychological effects. Of particular interest was a subgroup of 17 cases involving “brief awake paralysis” caused by drug errors, such as the inadvertent administration of NMB before or without intended anesthesia. Although these were considered separately from other AAGA cases, they were associated with the highest rates of distress and of psychological sequelae—emphasizing the importance of paralysis as a driver of distress and patient harm, Professor Pandit said. Overall, the study also found that reassurance and explanation offered to patients with suspected AAGA “seemed beneficial.” The researchers have outlined a recommended response by hospital officials when faced with a patient who reports having experienced accidental awareness. “Much of the trauma came from the sensation of paralysis,” Professor Pandit said. “It was the primary cause of the long-term trauma. Some of them actually thought they were dead.”
Accidental awareness, however, was much more likely to occur if neuromuscular blockade was not monitored with a nerve stimulator after the NMB. The researchers have produced a checklist that they recommend be incorporated into the World Health Organization’s Safer Surgery Checklist. Among the recommendations made in the report is the use of a nerve stimulator whenever NMB is used. “The most important practical message for anesthesiologists is related to the use of NMB—think twice before you use NMB,” Professor Pandit said. A quartet of induction agents also was discovered to be more commonly used in general anesthesia cases that resulted in accidental awareness. Thiopental led the list, popping up in 23% of AAGA reports, although it was used in only 3% of anesthetic inductions reviewed in the study. Etomidate, midazolam and ketamine also were overrepresented, although the relative scarcity of cases involving these three agents means the “data should be interpreted with caution,” the study noted. Total IV anesthesia (in all its versions) was used in 18% of accidental awareness cases, but just 8% of general anesthetics. Electroencephalogram-based depth of anesthesia monitoring was reported in 4.3% of all reports of AAGA but in only 2.8% of all anesthetics administered. Other risk factors were related to human errors. Accidental awareness was more likely to occur in cases involving after-hours operations, emergency surgery and junior staff. In fact, half of the reports of accidental awareness involved emergency or urgent care situations, which, in turn, often involved rapid sequence induction, “usually with thiopental.” The combination of rapid induction and thiopental appears to be “an important risk factor,” the study found. “Let’s have a professional debate about rapid sequence induction and which drugs should be used and why,” Professor Pandit said. “When searching the literature, we are unable to find modern-day, y cogent explanations about why the different drugs were used.” —Scott Van Voorhis
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CLINICAL ANESTHESIOLOGY
Mucosal Damage Possible From Hot Laryngoscope Bulbs New Orleans—When it comes to complications from tracheal intubation, mucosal burns are not often at the forefront of anesthesiologists’ concerns, but perhaps they should be. Research has concluded that the bulbs in older laryngoscopes can quickly and easily generate temperatures that can cause mucosal damage, a problem obviated by the use of LED bulbs. According to Michael H. Harris, MD, stable and bright light sources are critical for visualizing the larynx, thereby facilitating patient intubation. Although laryngoscopes often are analyzed according to their light production, heat production is rarely considered in their analysis. “When you think of laryngoscopes, you think of ease of use and visualizing structures,” said Dr. Harris, a postdoctoral research fellow at Wake Forest University School of Medicine, in Winston-Salem, N.C. “You don’t think of all the other inherent risks.” Nevertheless, airway burns associated with laryngoscope use have been reported in both adults and children, prompting the researchers to assess four different types of laryngoscopes for their heat-producing characteristics. To that end, the researchers measured bulb temperatures using a thermistor placed 1 mm from the light source on each laryngoscope blade. Temperature was measured over 10 minutes recorded at one-minute intervals for the following devices: five disposable MAC #3 laryngoscopes; a Welch Allyn MAC #3 LED Fiber Optic (Green Top) laryngoscope; a Welch Allyn MAC #3 standard laryngoscope; and a halogen “demo” light source blade. Standard battery sources were used, and each battery was tested using a voltmeter to ensure accurate baseline voltage. “After three minutes, the halogen ‘demo’ bulb was nearly at 44 C,” Dr. Harris reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A2168). “At four minutes, it was almost at 50 C. An important point is that human tissue necrosis begins at 43 C and gets faster with higher temperatures [Int J Hyperthermia 2003;19:267-294].” The highest recorded temperature was 50 C in the halogen demo bulb at 10 minutes. Although no recordings were made beyond 10 minutes, the demo bulb never reached a plateau. By comparison, the standard laryngoscope reached a plateau temperature of 39 C
at four minutes and then held this temperature. The LED fiber-optic laryngoscope held constant at 23 C. Dr. Harris told Anesthesiology News that some practitioners have tried replacing traditional incandescent bulbs with xenon bulbs in an attempt to further improve visualization. “Those bulbs actually get hotter,” he said, “and can reach 70 C to 80 C.
“There have been a few case studies that looked at endoscopes that use the xenon bulbs,” he continued. “One paper used a 33% power setting in endoscopes, noting a bulb temperature of 45 C fairly quickly. By the time they hit 100% power setting [maximum brightness], it was almost 100 C. So there’s a real risk in using the xenon bulbs.”
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Although a mucosal burn may not pose a significant risk in a healthy adult patient, it is quite a different story in immunocompromised adults and children, Dr. Harris said. “We want people to be aware of the risks when they replace the bulbs with nonstandardized bulbs, as [these bulbs] pose safety risks.” see burns page 17
A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1-4
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Edwards.com/ESR1 References: 1. Grocott et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013 2. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46 3. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154 4. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012 Edwards, Edwards Lifesciences, the stylized E logo and Enhanced Surgical Recovery are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710
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Ultrasound Accurately Predicts Difficult Intubations Montreal—The use of ultrasound to measure airway dimensions in order to predict difficult intubations has been proven reliable, potentially opening the door for its use in such situations. “The difficulty of airway management is one of the prime risks for mortality and morbidity in patients undergoing anesthesia,” said Faraj W. Abdallah, MD, assistant professor of anesthesia at
the University of Toronto, in Ontario, Canada. “We routinely resort to visual cues—like visual measurement of the ratio of tongue-to-oral cavity volume— to predict difficult airway. However, the sensitivity and specificity of this measurement does not exceed 65%. “Ultrasound is fairly noninvasive and permits us to visualize the oral cavity,” he said. “However, its applicability in
identifying the difficult airway has not been exploited because of a lack of evidence supporting its validity and reliability in this specific area.” With that in mind, the researchers enrolled 42 adults into the trial, each of whom was undergoing high-resolution computed tomography (CT) scan of the head and neck for management of lymphoma, breast, bladder or cervical
cancers. As part of the CT scan, the tongue-tooral cavity volume and tongue thickness-to-oral Faraj W. Abdallah, MD cavity height ratios were calculated. Two sonographers separately measured these same ratios using ultrasound, both before and after the CT scans. All patients had CT scans performed while in the supine position with their mouths open. They held 5 mL of water in their mouths (Figure). “The open mouth simulated the actual clinical scenario, while the water served to fix the tongue in one position because it wiggles a fair bit in awake patients,” said Dr. Abdallah, who discussed the study at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-21). “In addition, the water kicked out the air and got rid of the attenuation caused by the air, and allowed us to see the palate. Without it, you cannot see the palate to measure the height of the oral cavity.” Data from 41 patients were analyzed. The investigators found that Cohen’s κ coefficient for comparing CTT measured values of the ratio of tongue thickness relative to oral cavity height, as well as the ratio of tongue volume to oral cavity volume, was 0.94, suggesting that the first ratio is a highly accurate approximation of the second. It was also found that the κ coefficient for the comparison of ultrasound-measured ratio of tongue thickness to oral cavity height— and the same ratio measured by CT scan—was 0.87, suggesting that ultrasound is a very accurate approximation of CT scan. “We also found high inter- and intraoperator reliability [0.84 and 0.81, respectively], which means that different sonographers can replicate the same values and the same sonographer repeating the same test has the same measurement,” Dr. Abdallah explained. “We concluded that ultrasound is a valid and reliable tool for measuring dimensions of the tongue and oral cavity, which are relevant to identifying the difficult airway,” he added. “This opens the way to further studies examining the utility of ultrasound in identifying difficult airway.” Despite these findings, Dr. Abdallah recognized that the study is just a first step in what may be a lengthy research chain. “Finding a high tongue volume may well be a sign of a potential
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Given these results, the switch to LED-based laryngoscopes was a no-brainer for Dr. Harris, not only because of the decreased risk for injury, but also because they have the potential for clearer visualization. “Our recommendation would be to phase out the old laryngoscopes for newer LED-based scopes,” he said. “And if you’re using reusable laryngoscopes, do
not replace the bulbs with anything other than the factory-standard bulbs.” D. John Doyle, MD, chief of general anesthesiology at Cleveland Clinic Abu Dhabi in Abu Dhabi, United Arab Emirates, expected that the news regarding laryngoscope bulb heat would be surprising to many clinicians. “This gives us all the more reason to use LED bulb designs, which generate less heat, consume less energy per unit of light and last longer. It’s a no-brainer to me too: We should be changing
over to LED laryngoscopes as the old incandescent models are retired from practice. “By the way,” Dr. Doyle added, “not all laryngoscope designs place the bulb near the oral mucosa, such as the ‘green line’ models, where the bulb is in the handle, not the blade. These models would not be expected to offer a burn hazard.” —Michael Vlessides The authors had no relevant financial relationships to disclose.
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Figure. Patients had CT scans performed while supine and with open mouths, which held 5 mL of water. difficult intubation,” he said. “But we are not drawing conclusions about difficult intubation yet; we are simply validating the use of ultrasound. This study served as a precursor for other studies on the utility of ultrasound in predicting difficult airway.” D. John Doyle, MD, PhD, professor of anesthesiology at the Lerner College of Medicine of Case Western Reserve University, in Cleveland, told Anesthesiology News that the study not only advances the field of airway management, but also validates the use of ultrasound in measuring the dimensions of the tongue and oral cavity. “However, I wonder if—like the Mallampati classification—the obtained measurements might ultimately be found to lack sufficient sensitivity and specificity to be useful on their own,” said Dr. Doyle, who is also a staff anesthesiologist at the Cleveland Clinic Foundation in Ohio. “Another issue is whether the need for access to an ultrasound machine and its required training will present an obstacle to the technique, even if these measurements turn out to be valuable,” Dr. Doyle added. “Finally, one emerging school of thought holds that since difficult airway prediction remains fair at best, airway training efforts should instead emphasize means to handle unexpected difficult airways, such as the use of video laryngoscopy.” The abstract was honored as the meeting’s best in the Airway Management category. —Michael Vlessides
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Regional Anesthesia Found Safe for Low-Platelet Parturients Montreal—A review of the records of more than 20,000 women in labor has found that even those with platelet counts as low as 50×109/L can safely receive regional anesthesia (RA), under the right circumstances. Although RA is now the standard of care in laboring women, turning to epidurals and spinals in high-riskk parturients—especially those with low platelet counts— can be discomfiting. “On our labor floor, often we have patients with platelet counts less than 100,000,” said Jeffrey Bernstein, MD, assistant professor of anesthesiology as well as assistant professor of obstetrics, gynecology, and women’s health at Yeshiva University’s Albert Einstein College of Medicine, in New York City. “Because we have many high-risk OB [obstetrical] patients at our tertiary care center [Montefiore Medical Center], I wanted to see what our actual incidence of thrombocytopenia was, and what we’ve done in the past with respect to placing epidurals in these women.” Dr. Bernstein and his colleagues used a hospital database management program to identify 20,244 women who delivered at the hospital between September 2009 and 2013. A detailed chart review was then performed for 256 women (1.3%) who had platelet counts of 100×109/L or lower at preanesthetic assessment. Metrics included the etiology of thrombocytopenia, type of anesthetic technique, mode of delivery, major neurologic and anesthetic complications, and body mass index (BMI). The study was presented at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-184). The review found that 151 of the 256 women (59%) received RA. A total of 175 patients had platelet counts between 80×109/L and 100×109/L (mean BMI, 31.37±5.65 kg/m2); of these, 131 (75%) received RA: 89 epidural, 37 spinal and five combined spinal–epidural. “Between 80,000 and 100,000 platelets, physicians felt pretty comfortable about placing a neuraxial anesthetic,” Dr. Bernstein noted. In 76 patients (mean BMI, 31.41±4.94), platelet counts were 50×109/L to 79×109/L; 19 of these women (25%) received RA: 10 epidural and nine spinal. “In the patient group with platelets between 50,000 and 79,000, most had either stable or static situations, meaning idiopathic
thrombocytopenic purpura [ITP] or gestational thrombocytopenia where the platelets are not being consumed,” he added. “These patients are the big question for me,” Dr. Bernstein commented. “I mean, I can run across the highway 19 times and not get hit by a car. Does that mean it’s safe? Personally, I feel pretty comfortable with a count over
60,000 in patients with ITP or gestational thrombocytopenia that show no sign of abnormal bruising or bleeding, when I suspect that the platelet function is normal. If you have that with preeclampsia, the platelets can be abnormally functioning, but there may be an ongoing dynamic process where platelets might be consumed actively. The platelet count of 115,000 at 7
o’clock in the morning could drop to 80,000 by 2 o’clock in the afternoon.” Finally, 13 patients had platelet counts less than 50×109/L, one of whom (mean BMI, 35.82±10.20) had an epidural. No neurologic complications occurred in any patient. “It’s important to remember that the risk of hematoma exists when the catheters are being removed as well,” he
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Visit www.aboutULTIVA.com to see how Remi could work for you. *Remifentanil is commonly referred to as Remi by anesthesia providers. † Continuous infusions of Remi should be administered only by an infusion device and continuous monitoring is necessary. Interruption of infusion will result in rapid offset of effect. ‡ Within 5 to 10 minutes after discontinuation of Remi, no residual analgesic activity will be present. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Other analgesics should be administered prior to discontinuation of Remi where postoperative pain is anticipated. INDICATIONS ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting • As an analgesic component of monitored anesthesia care in adult patients
ULTIVA is a registered trademark of Glaxo Group Limited. The Mylan logo is a registered trademark of Mylan Inc.
©2014 Mylan Institutional
IMPORTANT RISK INFORMATION Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated. Vital signs and oxygenation must be continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension,
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CLINICAL ANESTHESIOLOGY said. “Taking the epidural her count bumped back up again, then we took it out, out is just as risky as put36 hours after she arrived at ting it in, so you want the same platelet count that the ward.” Bupesh Kaul, MD, clinyou were comfortable with when placing the catheter. ical associate professor I recently put a catheter in of anesthesiology at the a patient who had a count Jeffrey Bernstein, MD University of Pittsburgh, of 89,000. After she delivhelped trace the history of ered, it was 69,000, so I left the cath- neuraxial anesthesia use in laboring eter in. We took another count and women. “In the early 1990s, the peoit was 64,000; we still left it in. Once ple were very uncomfortable putting
in epidurals in patients with a platelet count below 100,000,” he told Anesthesiology News. “Sometime thereafter, we realized that the absolute platelet count number didn’t mean much. “Since then, the effort really has been to better predict the risk of bleeding in the epidural space,” he continued. “Since the early 2000s, the thromboelastogram has been used more and more, and seems to predict platelet function better than absolute platelet
Remi* is a potent μ-opioid agonist with rapid analgesic onset and peak effect, and short duration of action.†1
Rapid response†1
Early post-op neurological assessment‡3,4
Rapid recovery‡1
No accumulation1
Established hemodynamic profile1,2 Remi produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity. Please see Indications and Important Risk Information below, and accompanying brief summary of Prescribing Information on adjacent page for all precautions, warnings, contraindications, and adverse events. hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.
October 2014
Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. ULTIVA SHOULD BE USED IN A CAREFULLY MONITORED SETTING BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. References: 1. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011. 2. Twersky RS, et al. J Clin Anesth. 2001;13(6):407-416. 3. Wilhelm W, et al. Br J Anaesth. 2001;86(1):44-49. 4. Bilotta F, et al. Eur J Anaesth. 2007;24(2):122-127.
count. The thromboelastogram has allowed us to be much more comfortable at lower absolute platelet counts than was possible before.” Assessing clinical symptoms, such as bleeding from the gums, petechiae and bleeding from venipuncture sites is an important adjunct in determining the safety of neuraxial anesthesia in these patients, he added. —Michael Vlessides
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Study Elucidates Link Between Primary and Referred Pain
A
lthough the association between primary and referred pain is generally not well characterized, a study by an Iowa research team has shed more light on the link between the two pain types. The investigators found that a threshold level of primary pain is necessary to induce referred pain, and that there is a progressive relationship between referred
ULTIVA® for Injection
pain and the intensity of primary pain. “We still don’t know that much about referred pain,” said Laura Frey-Law, w MS, MPT, PhD, associate professor of physical therapy and rehabilitation science at the University of Iowa, in Iowa City. “One proposed theory is well documented and suggests that to get referred pain, one needs to hit a threshold level of local or
(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits
primary pain. So we decided to look at that more closely.” To that end, Dr. Frey-Law w and her colleagues enrolled 91 healthy adults (48 women) into the investigation; each was between the ages of 18 and 48 years. Each patient received four different infusions to the anterior tibialis muscle over five minutes: 40 mL per hour isotonic saline, 80 mL per hour isotonic
and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia
ULTIVA (n=921)
Alfentanil/ Fentanyl (n=466)
Postoperative Analgesia ULTIVA (n=281)
Morphine (n=98)
After Discontinuation ULTIVA (n=929)
Alfentanil/ Fentanyl (n=466)
8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0
0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0
61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)
15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)
339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)
202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)
1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0
0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0
19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)
4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0
17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)
20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)
*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a specific antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045
saline, 40 mL per hour 5.2 acidic phosphate buffer and 80 mL per hour acidic phosphate buffer. Patients were blinded to the study solution; infusions came in two visits spaced approximately one week apart. Patients were asked to verbally rate their pain every 30 seconds during the infusion using the Borg Category Ratio (CR10) scale at both the infusion site (which represents primary pain) and at the ankle/foot, a well-established d site for referred pain. “The saline induces a little bit of pain, and is usually from distention,” Dr. Freyy Law w said in an interview. “The acid, on the other hand, induces a deep ache, kind of like a muscle cramp.” As reported at the 2014 annual scientific meeting of the American Pain Society (abstract 189), held in Tampa, Fla., primary pain intensity was lowest with the slower saline infusion (1.3), followed by the faster saline infusion (1.6), the slower acid infusion (2.1) and the faster acid infusion (3). The incidence of referred pain followed the same progression, affecting 36.3%, 44%, 64.8% and 75.8% of patients, respectively. Logistic regression revealed that the odds of having referred pain rose 50% for each unit’s increase in primary pain intensity ratings. The predictability of referred pain incidence is optimal when primary pain intensity was approximately 2.5 to 3 on the CR10 scale. “There was also a bit of a jump [in pain intensity] between the saline and the acid,” Dr. Freyy Law w said. “So although the intensity of the pain was important, the source of the pain also seems to be important. The fact that the type of infusion becomes almost as much of a predictor as the pain intensity itself suggests that not all primary pain will equally induce referred pain,” she said. These findings suggest that by treating primary pain, practitioners may be treating the referred pain as well. Marie H. Bement, MPT, PhD, associate professor of physical therapy at Marquette University in Milwaukee, noted that the study highlights the importance of managing primary pain. “If primary pain is not well managed, it could progress to referred pain or even widespread pain, which is the hallmark of central sensitization,” she said. “To me, this study indicates that you need good primary pain management as a way to treat—or pre-empt—referred pain. It really highlights the importance of management and prevention.” —Michael Vlessides
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Patient–Provider Relationship Key in Managing Chronic Pain Paris—Treatment of chronic pain can be challenging, partly because of the associated problems of depression and anxiety. The patient–provider relationship is one of the key components of managing the psychological aspects of chronic pain, according to experts addressing attendees at the 2014 annual meeting of the European League Against Rheumatism. “Chronic pain is very tricky to treat. For a number of patients, their pain is essentially permanent and ‘untreatable,’ in the sense that it is not going to fully go away. Thus, the treatment can focus on helping patients to be as functional as possible with chronic pain,” said Kevin E. Vowles, PhD, associate professor in the Department of Psychology, the University of New Mexico, Albuquerque, who spoke at the meeting. The way in which physicians conduct themselves can influence outcomes, he said. Trust is essential, and the physician needs to convey that he or she has the patient’s best interest in mind. Trust is particularly critical to adherence, said Dr. Vowles, adding that “we know that just telling patients what to do does not work very well.” The physician needs to encourage behavioral change so that patients can adapt their expectations and become comfortable with their experience of pain, he said. For some individuals with chronic pain, this seems to be a viable option, particularly when treatments aimed primarily at pain control have failed to provide benefit or are disrupting functioning. “Psychology is all about behavior change, which is why it is important in the rehabilitation of chronic pain,” he said. “The ultimate outcome of treatment is not to alter an internal perception but to change the way patients respond to their pain so that they can get on with their lives, ideally in a manner that also allows increased engagement in valued and meaningful activity.” It is not useful for the patient to try to determine if the pain is “real” or “psychogenic,” he said. “This dichotomy does not help patients or providers. This is really an outdated concept. For example, in his 1976 book [“Behavioral Methods for Chronic Pain and Illness”], Wilbert E. Fordyce, PhD, outlined many ideas of psychogenic pain that were inaccurate at that time.” The provider needs to help patients understand that their pain experience will affect their emotions and behavior, and the provider should find ways to help the patient accept the pain and behave
so that the pain has as minimal an impact on function as possible. Some psychological strategies for the treatment of chronic pain include use of acceptance and commitment therapy (ACT), and mindfulness approaches as part of cognitive-behaviorall therapy (CBT). “I think treating the psychological components of chronic pain is absolutely critical,” agreed Ellen Slawsby, PhD,
director of pain services, Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston. Patients with chronic pain have high rates of anxiety and depression, she said. “We have found that 75% have depression, 60% have reduced enjoyment of life, 70% have poor concentration and 75% have sleep disturbances. We know pain is exacerbated by the
flight-and-fight response. Paying attention to patients’ psychology will improve symptom control and quality of life,” she said. Mind–body approaches are important. “Both ACT and CBT are part of mind– body approaches. Data show that the true relaxation response helps patients with chronic pain get better.” —Alice Goodman
For the Management of Postsurgical Pain
EXPAREL® (bupivacaine liposome injectable suspension)
Patient-Focused Pain Control With A Single Dose Long-Lasting Pain Control With Less Need for Opioids1,2 • Indicated for administration into the surgical site to produce postsurgical analgesia • Reduce pain and opioid requirements1,2 without the need for catheters or pumps
Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy and hemorrhoidectomy procedures. The clinical benefit of the attendant decrease in opioid consumption was not demonstrated.
Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL 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. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. References: 1. Gorfine SR et al. Dis Colon Rectum. 2011;54(12):1552-1592. 2. Golf M et al. Adv Ther. r 2011;28(9):776-788.
Please see brief summary of Prescribing Information on reverse side. For more information, visit www.EXPAREL.com ©2014 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054
PP-EX-US-0501
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Few Same-Day Interventional Spine Complications
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nterventional spine procedures have low same-dayy complication rates, according to an analysis of 26,151 such procedures performed at several centers in the United States. Less than 0.1% of the procedures resulted in a transfer to an emergency department (ED) or an aborted procedure, according to a presentation at the International Spine Intervention Society’s (ISIS) 2014
annual scientific meeting. The investigators undertook the study because of the wide variation in adverseevent rates reported in the literature and reports of some serious sequelae from interventional spine procedures, including paralysis. They examined three qualityy assurance databases: the Department of Radiology, Mayo Clinic, in Rochester, Minn.; the Rehabilitation
Institute of Chicago (RIC), Northwestern Memorial Hospital; and the Department of Physical Medicine and Rehabilitation, Penn Spine Center, University of Pennsylvania, in Philadelphia. The review included the following procedures at the three locations, respectively: 19,170 epidural steroid, facet and sacroiliac injections between 2006 and 2013; 6,280 epidural steroid, facet,
sacroiliac, medial branch block injections and medial branch radiofrequency neurotomies between 2004 and 2009; and 701 epidural steroid, facet, sacroiliac, medial branch block injections and medial branch radiofrequency neurotomies in 2009-2010. The procedures were performed primarily with 22- or 25-gauge needles, rare use of sedation and with trainees frequently present and/or participating. The total rate of verified, samedayy complications was 1.9% or 493 events, with 289 (58.6% or 1.1% overall) being short-term vasovagal reactions to the injections. Of the procedures, 163 (0.6%) were aborted, 20 (<0.1%) resulted in a transfer to the ED, and 10 (<0.1%) were dural punctures. Most of the aborted procedures were epidurals, with more being transforaminal epidural steroid injections rather than interlaminar epidural steroid injections. The primary causes for stopping the procedures were pain, vascular uptake of the injected medications and severe vasovagal reactions. The ED transfers were due to severe allergic or vasovagal reactions, chest pain and symptomatic hypertension. Allergic reactions occurred to both iodine-based contrast and gadolinium, and most were rashes with one laryngospasm. The percentages were roughly similar across the institutions. There were no major complications such as permanent neurologic deficit. “This study demonstrates that interventional pain procedures are safely performed with extremely low complication rates when evidence-based guidelines are observed,” said lead investigator Carrie Carr, MD, senior associate consultant, Department of Radiology, Mayo Clinic. Dr. Carrr was slated to give the presentation but was on maternity leave. Researcher David J. Kennedy, MD, clinical assistant professor, Orthopaedic Surgery, Stanford University School of Medicine, in Palo Alto, Calif., did instead. “The presentation highlights the safety of carefully performed interventional spine procedures, and can be used to help prepare clinicians and patients for some common side effects,” said Evan Rivers, DO, assistant professor, Department of Neurosurgery at the University of New Mexico School of Medicine, in Albuquerque, who attended the talk. —Rosemary Frei, MSc Drs. Carr and Rivers did not report any relevant conflicts of interest.
EXP-AP-0020-201301
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First Comprehensive Neurostimulation Guidance Unveiled
T
he Neuromodulation Appropriateness Consensus Committee (NACC) has released the first comprehensive guidance on best practices for neurostimulation for chronic pain. The guidelines, four peer-reviewedd articles totaling 101 pages that were authored by about 60 international experts, were published in the journal Neuromodulation (2014;17:515-615) and cover the following general areas: appropriate use of neurostimulation of the spinal cord and peripheral nervous system; stimulation of the intracranial and extracranial space and head; avoidance and treatment of complications of neurostimulation therapies; and new and evolving neurostimulation therapies. “There was such variability in practice around the world and in the United States as well. We really felt we needed to look at the literature, look at what seemed to be the most effective and safe therapies, and give guidance to our colleagues based on what the literature said. In addition, we filled in the gaps with the consensus of opinions of experts who were well published,” said Timothy R. Deer, MD, medical director, Center for Pain Relief, in Charleston, W.Va., and chairman of the NACC. The guidance was “absolutely needed,” according to Nicholas Scott, MD, an interventional pain physician at Arizona Pain Associates, in Scottsdale, who was not involved in developing the guidance. “It’s important to have guidelines that physicians can use for best practices, as these can lead to decreased complications and improved patient outcomes related to this valuable modality for pain control.” When he was asked if there was anything lacking in the guidance, Dr. Scott answered, “No, they covered quite a bit of ground. There’s nothing glaring that I see as lacking in the guidance.” Dr. Deer,r who is also a clinical professor of anesthesiology at West Virginia University, in Morgantown, cited three recommendations that the NACC made that are different from current practice. The first was best practices in infection control. According to a survey of infection control practices soon to be published, Dr. Deerr said, “Some doctors weren’t using any prophylactic antibiotics. We learned that people were doing various things with their preps and their irrigation techniques. In this guidance, we give best practices to avoid infection. While that sounds like it may be simple, if you look at the survey of what people
do, people are doing a lot of things, many of which probably aren’t the best things for the patient.” Dr. Scott agreed that the infection control guidance was needed. “I think the recommendations related to infection control are very important. We obviously want to make patients better; you know the Hippocratic Oath, ‘first, do no harm,’ is something that
I take very seriously and I think most physicians take very seriously. So, you don’t want to have a negative outcome when you’re trying to do pain relief.” The second and third NACC recommendations deal with handling bleeding and medications that affect bleeding, and the proper training required to get credentialed for these procedures. The NACC guidance will be
regularly updated, probably beginning in summer 2015, to include new data on existing devices and for the introduction of new devices. —George Ochoa Dr. Deer disclosed that he has been a consultant with Axonics, Bioness, Medtronic, Nevro, Spinal Modulation and St. Jude Medical. Dr. Scott did not report any relevant financial conflicts of interest.
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The Strange Early Days of Blood Transfusion A.J. Wright Librarian, Anesthesiology Department, University of Alabama at Birmingham
U
nless there are issues of contamination or supply, blood typing, banking and transfusion seem to us today to be standardized and safe medical procedures. Like so many developments in medicine and the sciences, however, the idea of blood transfusion and its early attempts long predate practical application. Thinking about blood and the history of medicine might bring to mind two subjects: William Harvey and bloodletting. In 1628, Harvey published his De Motu Cordis, also known as “On the Motion of the Heart and Blood.” In this work of only 72 pages, he outlined the heart’s action and the circulation of blood through the body. He developed this work from painstaking research on animals such as eels, fish and snails, using a single magnifying lens. Bloodletting resulted from the ancient medieval theory of “humors” in which good health depended on a balance of bodily fluids, including blood. This very common practice survived in some places almost 2,000 years, well into the late 19th century. The role and use of blood in a medical or health context is also ancient. The Roman poet Ovid described in his Metamorphoses how Medea gave youth to her father-in-law w by replacing his blood with an elixir. Roman philosopher Pliny the Elder noted how spectators would drink the blood of dying gladiators to transfer strength and bravery to themselves. Blood has been a part of the rituals of many cultures over the centuries. What qualifies as the first real attempted transfusion has been difficult for historians to determine. An ancient Hebrew manuscript describes curing the leprosy of the king of Syria by drawing out his blood and replacing it with blood from another person. Often cited as the first blood transfusion is an event sometime in the early 1490s. An anti-papist lawyer in Rome, Stefano Infessura, who died around 1500, described the attempt in his Diary of the City of Rome. When Pope Innocent VIII was on his deathbed, a Jewish physician named Abraham Meyre suggested infusing blood from three 10-year-oldd boys into the pontiff ’s veins. All three donors died and Innocent himself died on July 25, 1492. The Catholic Encyclopedia warned that Infessura’s work was full of gossip and not to be trusted. Most likely, if this event occurred, the pope drank the blood instead of it being transfused. By the mid-17th century, more believable events in this story begin to appear in the historical record. An English vicar, Francis Potter, apparently altered quills and pipes to use in man-to-man blood transfusion as early as 1639. His work and further improvements were described in the writings of a friend, John Abery, but there is no evidence actual transfusion was attempted. Francesco Folli of Florence and a Benedictine monk, Robert des Gabets, also wrote about the transfusion idea in mid-century. y At this time, real-life efforts at actual infusions and transfusions also began. Using small bird bones, the
German Georg von Wahrendorff injected wine into the veins of hunting dogs and other substances into sick canines. Johann Daniel Major is believed to have given medications to humans intravenously, and also suggested a method of blood transfusion with a cannula made of silver. Even better documented is work by two English greats, Christopher Wren and Robert Boyle. Wren demonstrated IV injections of various substances into dogs by means of an animal bladder and quills. Chemist and physician Boyle did similar experiments; ale, wine and opium were injected into dogs as early as 1656. Accounts by both men were published in the 1660s. In May 1665, another physician, Robert Lower of Oxford, described an animal-to-animal blood transfusion in a letter to Boyle. This letter was read at a Royal Society meeting in September 1666, and Lower’s book Tractatus de Corde includes a description as well. The great diarist Samuel Pepys also noted Lower’s experiments. The technique, Pepys said, quoting an informant, “may, if it takes, be of mighty use to man’s health, for the amending of bad blood by borrowing from a better body.”
Vignettes, in decorative oval borders, showing blood transfusions from animal to human; and from a healthy person and a sick person, arm to arm; and hand to hand. Mercklin, Georg Abraham, 1644-1702. Image published in 1679. Source: U.S. National Library of Medicine
Elsholtz, Johann Sigismund, 1623-1688, author. Two views of blood transfusions: An animal and a human arm are on one table, the necessary tubular attachments for making the connections are shown extending from the arm and the animal’s side; the second view is of two arms with tubes as above.
Early blood transfusion from lamb to man (1705).
Image published in 1667. Source: U.S. National Library of Medicine
Credit: Wellcome Library, London. Wellcome Images
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AnesthesiologyNews.com I 25
PRN felt that the blood of a vibrant wife could help a husband with melancholy. Members of the Faculty of Medicine in Paris were outraged by the work of Denis and others. They did not even recognize Harvey’s blood circulation theory, and condemned transfusions in print. The pope banned the procedure in 1679, and the research so active in Europe between 1639 and 1667 essentially stopped for more than a century. On Sept. 26, 1818, at Guy’s Hospital,
First page of article by James Blundell Source: Wikipedia
Also recorded by Pepys and in the Transactions of the Royal Society was Lower’s transfusion of animal blood into Arthur Coga on Nov. 22, 1667. Assisted by Dr. Edmund King, Lower used quills and silver pipes to convey blood from a sheep’s carotid artery into a vein in Coga’s arm. The following month, another transfusion was done, and Coga declared that he felt better. Pepys cryptically noted that Coga “is cracked a little in the head.” Lower’s work on a human was preceded in Paris by just a few months. Physician and astrologer Jean-Baptiste Denis (sometimes spelled “Denys”) had performed the first blood transfusion involving a human on either June 15 or 28, 1667. The patient was a feverish young man on whom other doctors had employed leeches 20 times; after Denis transfused him with several ounces of either dog or lamb’s blood, he “rapidly recovered from his lethargy.” Denis used a similar method to supposedly cure a madman, and a few more experiments by scientists in France and London were deemed successful. Denis had first experimented with animal-toanimal transfusions; he published a letter in the Journals des Scavans describing s his work. After one patient died, however, Denis was tried for murder. He was eventually exonerated because it turned out the patient’s wife had used arsenic to poison her spouse. Also to be noted at this time was Johann Sigismund Elsholtz, a German botanist, physician and alchemist who worked in the court of Friedrich Wilhelm of Brandenburg. His book Clysmatica nova, published in 1667, describes the potential of IV injections and research on blood transfusion. He
the practice was revived in spectacular fashion. English obstetrician and physiologist James Blundell became the first to transfuse human blood into another human with equipment he designed. He had first conducted animal experiments. Although the patient in this initial attempt died two days later, Blundell continued his efforts in 10 patients, five of whom survived. Almost a century would pass before Karl Landsteiner’s work on blood groups began the modern era of blood
transfusion and led to everything we now take for granted about the procedure. That work was preceded by centuries of now-strange theories and fitful efforts to make blood transference possible and useful. Suggested Reading Learoyd P. The history of blood transfusion prior to the 20th century—Part 1. Transfus Med. 2012;22(5):308-314. Moore P. Blood and Justice: The Seventeenth-Century Parisian Doctor Who Made Blood Transfusion History (2003).
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COMMENTARY RED TAPE
patient before he or she gets through the admission process. These include the surgical checklist, fall risks and β-blocker other regulatory and quality requirements are adding extra steps to a tightly comassessment on both inpatients and outpressed and inherently complicated peripatients. Inpatients have two additional operative workflow. assessments, and outpatients have three. These do not include our decolonization But just because compliance and protocol. These questionnaires are all quality-related red tape is a necessary evil Christine Doyle, MD important, but by process mapping, we doesn’t mean it should be added to the can ensure they’re conducted at the optiworkflow without careful forethought. The American Hospital Association reports that reg- mal time in the most efficient manner without any ulatory red tape adds at least 30 minutes to every repetition or overlap. hour of patient care at various stages in the health care continuum.1 This large amount of time points to significant opportunity for efficiency improvements. Determining how to reduce time spent on compliance tasks, however, requires analysis, process change and technology. In the end, though, the quantifiable results and soft benefits are worth it. CONTINUED FROM PAGE 1
Step 1: Process Mapping Perioperative clinicians and staff are likely so accustomed to the abundance of steps they perform in each case that they may not be able to list them. Like any habitual sequence, from a mother driving her kids’ carpool to a college quarterback running a play, the numerous tasks required to achieve the end result become rote. In many ways, this ingrained behavior is a good thing; however, it can make it difficult to know if each task in the perioperative workflow is contributing to or detracting from overall efficiency. In an environment where new requirements are added on an ongoing basis, new compliance or quality-related steps may not seem like much—that is, until you’ve mapped them and can see the end-to-end process on paper. Identifying every step in the process may seem like a lot of work, but it saves both time and money exponentially as you implement changes. In our current operating room (OR), we now have a minimum of five sets of questionnaires or assessments for every
A process map can reveal the innate inefficiencies and duplications resulting from years of added requirements. As you map every step of perioperative workflow, from all preadmission tasks through pre-op, postanesthesia care unit and post-op, the areas that need improvement will become evident. The process map can also help you build an action plan and a timeline, and prioritize what needs to be accomplished.
Step 2: Front-Loading Paperwork During process mapping, you’ll likely notice that patients are queried about the same topics multiple times throughout the care continuum. Not only does this repetition create inefficiency and delays, but it can also decrease patient satisfaction. Fortunately, much of this patient information can be acquired in advance through pre-op phone calls and surveys. Patients often have a better mindset and are more prepared when asked questions via phone than in pre-op. Many patients prefer responding to preop questionnaires online, which delivers data to the perioperative team in a timely fashion while reducing administrative tasks. Providing many options—phone calls, surveys downloadable from the hospital website, and emailed PDFs— can increase the odds of getting patient information early in the process. Additionally, having patients undergo testing and lab work before the day of surgery can further streamline the care process and reduce chances for delays. In short, the more you can accomplish in the days or weeks before surgery, the more efficient your perioperative workflow will be. Step 3: Centralizing Information Implementing process improvements and conducting as many activities as possible before the day of surgery will yield positive results, to an extent. To achieve maximum results, however, the entire perioperative team must be able to share and access the same information. Often, anesthesiologists and surgeons must search for an important piece of patient data such as lab results. The longer they search, the longer they’ll be delayed—and the greater the likelihood that their delay will affect other cases in the perioperative queue. A centralized system allows the entire care team— anesthesiologist, pre-op nurse, surgeon and even nonperioperative clinicians such as hospitalists—to share patient information, knowledge and status updates. As a result, clinicians won’t have to search for critical
Enhanced Recovery Program for Colon Cancer Cuts Costs
A
program to help patients recover after colorectal cancer surgery reduced their hospital length of stay (LOS) by three days and saved $4,800 without increasing 30-day readmission rates, researchers have found. The researchers examined practice patterns and patient outcomes for 244 patients undergoing elective colon and rectal resection at an Oregon community hospital before and after institution of the recovery program (JAMA Surg g 2014 Jul 23. [Epub ahead of print]). The program focused on patient education, optimal management of fluids, minimal
incision length, decreased use of tubes and drains, opioid-sparing analgesia, and early mobilization and eating after surgery. From 2009, before implementation of the program, to 2012, the use of laparoscopy increased by about 30%, from 57.4% to 88.8% of cases, and LOS decreased by three days, from 6.7 to 3.7 days, according to the researchers at Oregon Health & Science University (OHSU), in Portland. Some researchers found that although they were able to reduce the initial hospital LOS with socalled Early Recovery After Surgery
(ERAS) programs, this came at the cost of more patients requiring readmission, according to study author Cristina Geltzeiler, MD, a surgeon at OHSU. “In our study, we did not find this to be the case,” she said. “In our study, patients were able to recover more quickly, and be safely discharged without an increased risk for requiring hospital readmission. In fact, with the ERAS program, our patient population had a decreased risk for requiring readmission, although this decrease did not reach statistical significance.” Reductions in LOS resulted in
estimated cost savings of $3,202 per patient in 2011 and $4,803 per patient in 2012. The use of patient-controlled opioid analgesia also decreased, from 63.2% to 15% of patients, as did the duration of use (67.8 vs. 47.1 hours before and after the intervention, respectively). The incidence of postoperative ileus also declined, from 13.2% to 2.5% of cases, as did the proportion of patients who experienced intraabdominal infection, from 7.4% to 2.5%, according to the researchers. —Paul Bufano
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COMMENTARY MOCA
CONTINUED FROM PAGE 1
and enhanced status and outcomes for the specialty. Now some anesthesiologists are complaining that this maintenance of board certification (MOC) lacks relevance, is ineffective and costs too much. They are pushing back. Anesthesiologist opposition to MOC has grown at a grassroots level, in sync with opposition by other specialists to their own MOC programs. Many clinicians seem unaware of this
data that can affect care decisions. For instance, one of our recent patients had already been treated in our facility, and in our integrated perioperative information technology and anesthesia record solution, Surgical Information Systems, the anesthesiologist had noted that the patient had difficulty being intubated. She also included details about the exact type and size of tube and device used to place it, which enabled us to know how his care team had addressed this difficulty. The patient and his family were pleasantly surprised that we already had these details about his medical history, and we were able to proceed more efficiently. Saving 2,080 Hours Per Year … and Counting Through these measures, our OR has reduced the day-off admission intake process by 25%. With a typical caseload of 85 per week, this improvement equates to 40 hours of saved time each week—or 2,080 saved hours in a year. Although quality and compliance measures will likely never top physicians’ list of favorite activities, making these tasks a more efficient part of workflow can yield quantifiable results—and even move them from the “necessary evil” to the “not so bad” category. More importantly, such improvements can enhance satisfaction among both patients and clinicians alike, all while ensuring your team maintains compliance and regulatory standards. Reference
push-back, including society leaders, but that is likely to change. MOC Anesthesiology (MOCA) opponents are organizing through common-cause websites, informational articles and meetings. They are petitioning leaders, filing lawsuits and driving debate on the merits and costs of MOCA. In a recent survey of published studies, Buscemi et al found little support for the assumption that certified or recertified internists have better patient outcomes.1 Paul Kempen, MD,
PhD, an anesthesiologist, editorialized, “The MOC premise that physicians become outdated with extended time … is a fallacy. Experience is the significant factor at multiple levels of medical decision.” He asked, “Why comply with MOC?” and essentially answered, “Only because you currently must.”2 Most anesthesiologists have ignored such protestations as uninformed rants from disgruntled clinicians. But MOC opposition is gaining followers. In a New England Journal of Medicine poll,
63% of 2,512 physicians recommended that those already board-certified not enroll in MOC.3 In the battleground state of Ohio where the Board of Medicine proposed a maintenance of licensure program to reinforce MOC, the Ohio State Society of Anesthesiologists, along with 10 other societies, signed a letter opposing any effort “to implement different maintenance of licensure requirements than those currently in place,” primarily 100 hours see MOCA page 28
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1. Patients or Paperwork? The Regulatory Burden Facing America’s Hospitals, A PriceWaterHouse Coopers Report Sponsored by the American Hospital Association. July 2008. http://www.aha.org/ content/00-10/FinalPaperworkReport.pdf.
Dr. Doyle is president of Coast Anesthesia Medical Group and staff physician at O’Connor Hospital, San Jose, Calif. She currently serves as a delegate for the American Society of Anesthesiologists and speaker for the California Society of Anesthesiologists.
Society of Cardiovascular Anesthesiologists 8735 W. Higgins Road • Suite 300 • Chicago, IL 60631 Phone: 855.658.2828 • Fax: 847.375.6323 • E-mail: info@scahq.org Please keep an eye on www.scahq.org for up-to-date information on these events.
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COMMENTARY MOCA
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of continuing medical education every two years. The Wall Street Journall reported in July that “many doctors are deriding the MOC requirements as costly, irrelevant and time-consuming, and largely a moneymaking venture for the specialty boards.” In September, Anesthesiology News published an article on derisive opposition to MOC. In the October ASA Newsletter, Jeff Andrews,
MD, ABA secretary, wrote, “We understand that the cost of MOCA participation goes beyond the ABA MOCA fee and are exploring ways to increase the value of these costs. … The ABA is actively engaging in a variety of MOCA redesign activities.” You can find the arguments of MOCA opponents on the websites of the Association of American Physicians and Surgeons (AAPS), the Change Board Recertification organization, and Docs 4 Patient Care. The
AAPS has filed suit in federal court against the American Board of Medical Specialties (ABMS) “to end antitrust violations and misrepresentations by ABMS concerning its proprietary recertification program, which reduces access by patients to physicians.” The suit alleges that “ABMS enriches itself, its executives, and its co-conspirators by promoting falsehoods that its proprietary product is somehow indicative of the professional skills of a physician, when it is not.”
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I have recertified three times during my career and supported MOCA for younger anesthesiologists, but am sympathetic to their complaints. It is expensive. The current fee for the recertification cognitive exam is $2,100. The simulation center nearest me charges $1,800 for its one-day MOCA-required course. The American Society of Anesthesiologists (ASA) online educational programs, which advertise that they help “meet MOCA Part 2 requirements,” cost $360 per year for members and $830 for nonmembers. Multiplied by thousands of purchasers, MOCA generates considerable revenues for both the ABA and ASA. With more than 750,000 U.S. physicians holding one or more certificates from ABMS member boards, the broader market involves billions of dollars. So why do we have MOCA, and why do so many support it? The answers lie in public demand for physician competence and high-qualityy care, as well as recognition by anesthesiologists that best practices are changing, and MOCA is a good way to demonstrate keeping up. For the ABA and ASA, the answers also may lie in funds they need to keep their current programs going. The ABMS describes MOC as a professional response to the need for public accountability and transparency. MOC allows physicians to demonstrate their quality of care compared with peers and national benchmarks. According to a 2010 ABMS survey, 95% of the public rates participation by their physicians in MOC as important. Consumer’s Checkbook, a nonprofit physician rating service, recommends that patients only select physicians who are board-certified, and advises that “participation in an ongoing MOC program is evidence that a physician is taking extra steps beyond getting initial certification to continue to keep up-to-date and improve.” MOC is the culmination of years of professional selff regulation, meaning some physicians view it as theirs to continue changing. Patients and the public, however, are replacing physicians as the primary drivers of physician certification, and they want safety, efficiency and quality, not “buyer beware” health care. Through their control of Medicare and Medicaid, they have already implemented value-based purchasing, the physician quality reporting system, the Physician Payments Sunshine Act, and other quality and transparency initiatives, see MOCA page 30
JANUARY 2015
AnesthesiologyNews.com I 29
CLASSIFIEDS CRITICAL CARE-TRAINED ANESTHESIOLOGIST A faculty opening exists at the Medical College of Wisconsin, Milwaukee, WI, for a ĐƌŝƟĐĂů Đare-trained anesthesiologist with strong academic interests. The applicant must be board eligible or board ceƌƟĮed in anesthesiology and must have completed at least one year of ĐƌŝƟĐĂů Đare fellowship training. Our intensivists manage the care of paƟents in the surgical intensive care units and the cardiovascular ICU of several hospitals. The Department has an ACGMEapproved criƟcal care fellowship. Send a cover leƩer and CV to David C. WaƌůƟer MD PhD, John P. Kampine Professor and Chairman, Department off Anesthesiology (dwarůƟer@mcw.edu) or fax to (414) 805-8701. The Medical College of Wisconsin is an equal opportunity employer.
ACADEMIC PEDIATRIC ANESTHESIOLOGIST - COLUMBIA, MO.
DIVISION CHIEF NEUROANESTHESIA – UNIVERSITY OF MIAMI
Seeking Asst/Assoc/Prof with experience in NeuroAnesthesia. Division chief will provide clinical care, teaching, research, & academic development of faculty. Division Director will maintain service commitments at Jackson Memorial Hospital/University of Miami Hospital. Director will implement a NeuroAnesthesia Fellowship at University of Miami. Candidate must be ABA cerƟĮed or equiv; have strong academic background, demonstrated excellence in research, clinical care & teaching. A NeuroAnesthesiology fellowship is required, & clinical experience may be considered. Dept. has a very busy Neurosurgical pracƟce and endovascular service. The University of Miami is an ĂĸƌŵaƟve acƟon & equal opportunity employer. Candidates are encouraged to apply by submiƫng a lĞƩer of interest explaining academic aspiraƟons, curriculum vitae & 3 leƩers of reference. Electronic submissions preferred. Contact:
The University of Missouri (UM) Department of Anesthesiology and PerioperaƟve Medicine is seeking a fellowship-trained pediatric anesthesiologist. Successful candidates will be ABA cerƟĮed or eligible. Academic rank and pay is based upon qualiĮcaƟons in either a tenure or non-tenure track. An interest in teaching is essenƟal; research experience is desirable. The pracƟce is based at the UM Women’s & Children’s Hospital where all pediatric surgical subspecialƟes are represented except solid organ transplant and cardiac surgery. The department supports pediatric emergency services, criƟcal care transport, a PICU and a NICU. Three pediatric anesthesiologists currently share clinical responsibiliƟes and home call for all high risk pediatric cases. During regular duty hours, they provide care for adult paƟents on occasion. UM oīers a generous compensaƟon and beneĮt package. Columbia is a vibrant university community of over 100,000 with a low cost of living. It has been cited by Money Magazine as the 13th most highly educated municipality in the US and by Outside Magazine as one of the 10 Best US communiƟes. For addiƟonal informaƟon about the posiƟon, please contact: B. Craig Weldon, MD at weldonb@health.missouri.edu An Equal Opportunity/Access/AĸrmaƟve AcƟon/Pro Disabled & Veteran Employer To request ADA accommodaƟons, please call Human Resource Services at 573-882-7976.
David A. Lubarsky, MD, MBA, Professor & Chairman, Dept. of Anesthesiology, University of Miami, 1611 NW 12 St., C301, Miami, FL 33136; phone: (305) 585-7037; dlubarsky@med.miami.edu
Large, stable, and growing Chicago-area prĂĐƟce is seeking BC/BE anesthesiologists. t t t t t t
PosiƟons are available for general pƌĂĐƟĐe, pain and cardiac. CompeƟƟve salary with opportunity for rapid advancement to $350,000 plus. BeneĮts package including 401(k) with match, health and disability insurance, CME allowance, and full malpƌĂĐƟĐe insurance coverage including tail. Leadership track opportuniƟes leading to addiƟonal compensĂƟon. Nurturing work environment with mixture of personal cases and care team model. 6 weeks paid vacĂƟon.
Interested candidates should send inquires to KaƟe Enright at kenright@conƟnentalanesthesia.com. Mailing address: 1301 West 22nd Street, Suite 610, Oakbrook, IL 60523; telephone: 847.772.2293
me
jefferson.edu/c
For classified advertising, contact Craig Wilson 212-957-5300 xĂăĆƫƫđƫƫcwilson@mcmahonmed.com
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COMMENTARY
gy Vectors of Infection in a Modern World Disinfecting your wired world Peter J. Papadakos, MD, FCCM, FAARC
O
ver the past five years, there has been an explosion in the use of electronic medical records (EMRs) and personal electronic devices (PEDs) by health care workers. Patient and visitor use of PEDs in the clinical setting is popular and common. The current Ebola crisis has brought to light the shortcomings of control policies in modern health centers. As early as 2013, there were press reports of transmission of the virus via a cell phone in Uganda.1,2 However, few guidelines even address how shared computer keyboards and smart screens affect the spread of disease between health care workers and patients. The way we use such devices, without thinking, as part of our daily routine, could develop into an ideal vector for such a deadly infection. Studies already have reported that 5% to 21% of health care workers’ mobile phones provide a reservoir of bacteria known to cause infections,3,44 but if we look at any clinical setting, we see health care workers constantly entering information through shared keyboards and constantly using the touch screens of their PEDs without thinking that such practices can spread infection to themselves and others. I can picture a scenario in which individuals are treating a contagious patient in full gown, gloves and mask coming into contact with bodily fluids and using a PED, and then using that same PED to respond to a text without gloves a few moments
MOCA
CONTINUED FROM PAGE 28
often over physician protestations. If MOC devolves into a compiler of selff selected educational credits, public takeover of board certification and MOC could follow. Still, many physicians are pushing back against MOC. Delegates at the November meeting of the American Medical Association adopted principles emphasizing the need for an evidence basis to MOC and regular evaluations to ensure its relevance
after removing the protective gear. In a world that is wired to respond to every alert and message, even the best-educatedd health professional may not stop to think that a keypad or screen was not disinfected after treating the last patient. Even in 2008, a microbiological analysis of 75 doctors’ mobile phones isolated a total of 90 bacterial pathogens5; and since this study was undertaken before the widespread use of smart screens and EMRs, the numbers can only have increased. We must all be aware of this hidden vector of the spread of new, potentially deadly infections. A question to be asked in any debate on containing a virulent pathogen is the role of these new technologies that are touched by all, but cleaned by few. Thus, I believe regulatory agencies, hospitals and health care providers should address this important issue. We must also be aware that patients and their families and visitors also contaminate their PEDs and may also act as vectors by infecting large numbers of individuals who may share or use their PEDs. I recommend that health care workers and the population at large be educated with clear guidelines and advice on smart screen and PED etiquette and the proper cleaning and disinfecting of such devices. This current Ebola environment may be a catalyst for such education. Starting today, we must develop preventive strategies like routine decontamination of PEDs, smart screens and keyboards with proper disinfection agents. Such agents should be part of our regular use
of such devices, and manufacturers should push for their use. We should have a policy Peter J. Papadakos, of leaving PEDs and clinical MD, FCCM, FAARC computers outside the room so as not to contaminate them. For decades, we have treated patients with virulent infections and did not bring the chart rack into the room and we did not write our notes with contaminated gloves, so why should we change that practice today? Dr. Papadakos, a member of the Anesthesiology News advisory board, is director of critical care medicine at the University of Rochester Medical Center, in Rochester, N.Y. He writes and lectures on the impact of technology on medical care.
References 1. Caulfield P. Ugandan thief contracts Ebola virus from swiped cell phone. New York Daily News. August 27, 2014. http://m.nydailynews.com/ news/world/ugandan-thief-contracts-ebola-virus-swiped-cell-phonearticle-1.1145232. Accessed November 6, 2014. 2. Campbell A. Ebola phone theft: man steals from quarantined Uganda hospital patient, contracts virus. Huffington Post.t August 27, 2012. http://m.huffpost.com/us/entry/1832927. Accessed November 6, 2014. 3. Brady RR, Verran J, Damani NN, et al. Review of mobile communication devices as potential reservoirs of nosocomial pathogens. J Hosp Infect.t 2009;71:295-300. 4. Brady RR, Hunt AC, Visvanathan A, et al. Mobile phone technology and hospitalized patients: a cross-sectional surveillance study of bacterial colonization and patient opinions and behaviors. Clin Microbiol Infect.t 2011;17:830-835. 5. Tambekar DH, Gulhane PD, Dahikar SG, et al. Nosocomial hazards of doctors’ mobile phones in hospitals. J Med Sci. 2008;8:73-76.
competence, because the need is to clinical practice. Other principles adopted include prohibiting MOC for great, demand powerful and changing times obvious. licensure, credentialing, payment or network participation, as well as ensur- • My second bet is that ABA and ASA ing it not be cost-prohibitive or present leaders will accommodate MOCA barriers to patient care. enrollees and potential enrollees, So how will the contest between finding ways to increase program physician autonomy and public control relevance and reduce its costs. An end, specifically between anesthesiolounderstood military principle states gist opposition and ABA support for that leaders too far in front of their MOCA? troops when fighting breaks out get • My first bet is on the public, that shot in the back. • My third bet is that this will not be MOCA will increasingly become a way to assure anesthesiologist easy.
Dr. Johnstone is professor of anesthesiology at West Virginia University in Morgantown, and a frequent contributor too Anesthesiology News.
References 1. Buscemi D, Wang H, Phy M, et al. Maintenance of certification in internal medicine: participation rates and patient outcomes. J Community Hosp Intern Med Perspect.t 2013;2:10.3402/chimp.V2i4.19753. 2. Kempen PM. Maintenance of certification—important and to whom? J Community Hosp Intern Med Perspect.t 2013;3:20326. 3. Kritek PA, Drazen JM. Clinical decisions. American Board of Internal Medicine maintenance of certification program—polling results. N Engl J Med. 2010;362:e54.
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REPORT Major Abdominal Surgery This monograph is based on the 2nd Enhanced Recovery After Surgery (ERAS) USA Symposium held on October 10, 2014 in New Orleans, Louisiana. ven in the absence of morbid events, patients undergoing major open colorectal surgery traditionally experience a significant decline in function requiring prolonged rehabilitation during the postoperative period. Additionally, despite improvements in surgical technology and perioperative care, care complication rates of 1 30%, and even as high as 45% to 50%, 2,3 have been reported after major elective open colorectal surgery in the traditional perioperative care setting. A number of traditional interventions that are routinely used have been shown to be outdated, not evidence-based, and even harmful to patients.4-7 Long periods of physical inactiviity and d starvation i perioperatively i i l
E
Faculty Authors Timothy E. Miller, MB, ChB, FRCA Assistant Professor of Anesthesiology Department of Anesthesiology Duke University Medical Center Durham, North Carolina
Tong J. Gan, MD, MHS, FRCA Professor and Chair Department of Anesthesiology Stony Brook University Hospital Stony Brook, New York
Julie K. M. Thacker, MD Assistant Professor of Surgery Department of Surgery Duke University Medical Center Durham, North Carolina
induce a loss of muscle mass and deconditioning, which in turn correlates with postoperative complications and fatigue.8 The geriatric population and individuals with limited physiologic reserve are least able to tolerate a decrease in functional status and are therefore at greater risk. If a perioperative complication occurs, occurs the long-term sequelae and associated health care costs can be profound. The occurrence of a 30-day postoperative complication is more important than preoperative patient risk in determining survival after major surgery, and perioperative complications have been shown to decrease longterm median survival after surgery 9 by 69% b % iin a 10-year follow-up. f ll
Supported by
REPORT Enhanced recovery pathways (ERPs) are multimodal perioperative care pathways designed to attenuate the stress response during the patients’ journey through a surgical procedure, facilitate the maintenance of preoperative bodily compositions and organ function, and in doing so achieve early recovery.10 ERPs integrate a range of perioperative interventions to maintain physiologic function and facilitate postoperative recovery.11 ERPs in colorectal surgery were pioneered in the late 1990s by Professor Henrik Kehlet, who asked the fundamental question, “Why is the patient still in hospital?” Although the causes were multifactorial, the common end point that keeps patients in the hospital after uncomplicated major abdominal surgery is delay of the return of bowel function. This is influenced by several perioperative factors including the need for parenteral opioid analgesia, surgical approach, IV fluid management, and bed rest caused by lack of mobility. These factors often lead to delayed recovery and discharge from the hospital. The various elements of ERPs are aimed to address these issues, and the interventions that facilitate early recovery cover all 3 phases of the perioperative period (Table). The essence of enhanced recovery after surgery (ERAS) or “fast-track” surgery pathways is to accelerate recovery by attenuating the stress response. With successful reduction in perioperative stress response, the hospital length of stay (LOS), the incidence of postoperative complications and overall mortality rate can be reduced. An observed added benefit of reducing health care costs also is associated with these improvements to clinical outcomes.10,11 There are several elements of ERPs that are new and specific to this approach, bringing together 2 best practices: 1) organization of care and 2) clinical management, while ensuring that patients receive evidence-based care. In the 2000s, ERAS pathways in colorectal surgery were applied throughout Europe, and the first consensus guidelines were published in
2005.12 Since then, ERAS pathways have been adopted worldwide, and pathways and guidelines have been published for other major procedures because the principles of ERPs apply to all patients undergoing major surgery. Successful implementation of ERPs requires collaboration between surgery, anesthesia, and perioperative nursing to provide optimal perioperative care. Anesthesiologists play a vital role in facilitating recovery because they routinely carry out some of the key elements of ERPs (ie, preoperative assessment, perioperative fluid management, and optimal analgesia).
Preoperative Components Preoperative components of an ERAS protocol involve patient education, preoperative evaluation and optimization, and techniques to minimize preoperative fasting. An informed, prepared, physiologically optimized, and fed-state patient is the goal. Patient education is an essential part of any ERAS program. The aim is to educate the patient about the program, to set realistic expectations for postoperative recovery, and to psychologically prepare the patient, as well as family members, for the care program. Written information at an appropriate literacy level should be provided, detailing explanations of the procedure along with goals for postoperative recovery. Detailed preoperative information given to patients may diminish fear and anxiety and aid postoperative recovery.13 Preoperative evaluation and optimization aim to optimize and risk-stratify patients, thus aiding with the consent process, choice of surgical procedure and anesthetic technique, and determination of the appropriate postoperative location. Recent cohort studies have reported that mortality and morbidity are still common after major surgery. Mortality ranges of 3% to 4% after major abdominal surgery have been reported,14,15 whereas overall morbidity is even more common (21%-30% after colorectal surgery14) and is often associated with a decline in functional
Table. Typical Elements in an Enhanced Recovery Protocol Preoperative
Intraoperative
Postoperative
Identify patients
Minimally invasive surgery
Early feeding
Education about program
Goal-directed fluid therapy
Early mobilization
Screen for malnutrition
Regional anesthesia
Optimize fluid regimen
Carbohydrate drink
PONV prophylaxis
Optimize analgesic regimen
Selective bowel preparation
Antibiotics before incision
No NG tube or urinary catheter
Smoking cessation
Thromboprophylaxis
Multimodal analgesia
NG, nasogastric; PONV, postoperative nausea and vomiting
2
REPORT capacity and quality of life.16 In addition to evaluation and optimization of chronic diseases (eg, cardiovascular status, anemia, diabetes), preoperative evaluation should include help with smoking cessation and optimization of nutritional status (with oral supplements if needed). One month of abstinence from smoking is required to reduce the incidence of pulmonary complications.17 Additionally, prehabilitation to improve physical fitness before surgery is an emerging concept that is safe and effective, although evidence for improved outcomes is currently limited.18 Cardiopulmonary exercise testing (CPET) has been used to objectively evaluate exercise capacity preoperatively, and could be used to guide prehabilitation programs.19 There is no scientific evidence behind the dogma of fasting the night before elective surgery. Current preoperative fasting guidelines for adult patients undergoing elective surgery recommend a minimum fasting period of 2 hours for clear liquids and 6 hours for a light meal.20 Examples of clear liquids include, but are not limited to, water, fruit juices without pulp, carbonated beverages, clear tea, and black coffee. Additionally, a preoperative 12.5% carbohydrate drink containing mainly maltodextrins (complex carbohydrates) has been shown to reduce preoperative hunger, thirst, and anxiety. There also are metabolic benefits in undergoing surgery in a metabolically fed state, with less protein loss, reduced postoperative insulin resistance (resulting in better glucose control), and bettermaintained muscle strength.21 Current evidence suggests that a preoperative carbohydrate drink can be given safely to all patients, including those with diabetes.22 There also is a lack of evidence for another dogma of surgical practice: the routine use of mechanical bowel preparation (MBP) for colonic and other major abdominal surgeries. There is no evidence that MBP decreases complications such as anastomotic leakage or wound infection.23 Indeed, one study has shown that patients receiving MBP may have a tendency toward higher incidence of spillage of bowel contents and complications.24,25 Because MBP is associated with side effects such as dehydration and electrolyte disturbances, and is unpleasant for the patient, its routine use is not recommended in colon and other major abdominal surgeries.11 Further trials are needed in rectal surgery, where MBP may be necessary. Additionally, some surgeons prefer the use of MBP for laparoscopic surgery to improve bowel handling.
Intraoperative Components Intraoperative elements are the key to successful ERAS pathways, and lay the groundwork for early mobilization and feeding. Surgical and anesthetic factors should be considered in developing ERAS pathways.
Laparoscopic Surgery Laparoscopic surgery for colon resections is recommended if the expertise is available.11 Minimally invasive surgery in colon resection reduces the incidence of postoperative
complications and hospital LOS, while providing equivalent cancer outcomes.11 Laparoscopic surgery within an ERAS protocol has shown superior recovery to all other combinations (ie, open surgery within an ERAS protocol, laparoscopic surgery with standard care).26 There is less evidence from randomized controlled trials (RCTs) for the benefits of laparoscopic surgery in rectal surgery. However, it has been shown to be safe with equivocal disease-specific outcomes, and thus will undoubtedly be strongly driven by patients and surgeons.
Fluid Management Fluid and pain management are the 2 major anesthetic factors to be considered when developing an ERAS protocol. Fluid management within ERAS should be viewed as a continuum through the preoperative, intraoperative, and postoperative phases. Each phase is important in improving patient outcomes, and suboptimal care in one phase can undermine best practices within the rest of the ERAS pathway. The goals of intraoperative fluid management are to maintain central euvolemia and minimize salt and water excess. To achieve this, patients undergoing surgery within an ERP should have an individualized fluid management plan. As part of this plan, fluid excess should be avoided. Excess fluid administration will result in fluid shifting out of the circulation and into the interstitium.27 The resulting interstitial edema can result in edema of the gut wall and prolonged postoperative ileus. Even a modest positive salt and water balance causing a weight gain of 3 kg after elective colon resection has been shown to delay recovery of gastrointestinal function, increased complications, and extended hospital LOS.5 Maintenance fluid requirements during surgery can be delivered with a 1 to 3-mL/kg per hour infusion of a balanced crystalloid solution, with the aim of maintaining preoperative body weight.28,29 The term fluid restriction should be abandoned because it implies causing deliberate hypovolemia. A better term to describe a low crystalloid therapy regimen is zerobalance fluid therapy. y For low-risk patients undergoing low-risk surgery, a zerobalance approach might be sufficient. However, during major surgery there also is a significant body of evidence supporting individualized goal-directed fluid therapy (GDFT). GDFT refers to individualized fluid management using a minimally invasive cardiac output monitor. GDFT uses algorithms incorporating fluid challenges to optimize stroke volume (SV) and avoid episodes of hypovolemia and postoperative oxygen debt (Figure 1). This technique also has been referred to in the literature as SV optimization, and has been shown to reduce LOS and complications after major surgery.30 In an ERP setting, the benefit of GDFT may be less than in older studies when crystalloid excess in the control group was the norm.31 Additionally, avoiding prolonged preoperative fasting has made intraoperative fluid management easier, with patients less likely to be fluid responsive upon arrival in the operating room.
3
REPORT However, a number of patients continue to receive preoperative bowel preparation, have significant comorbidities, and experience prolonged surgery with blood loss. Although ERAS programs may have raised the threshold for benefit, there will still be patients (some expected, some unexpected) for whom SV optimization will be beneficial. Ultimately, the additional benefit of GDFT should be determined based on surgical and patient risk factors.
Pain Management
Stroke Volume
Optimal pain management strategies should provide good pain relief, facilitate early mobilization and feeding, and avoid side effects and complications. This is best achieved by avoiding escalation of IV opioids as much as possible through the use of multimodal analgesia regimens and regional anesthesia (Figure 2). 32 Opioid use leads to a host of undesirable side effects such as respiratory depression, postoperative nausea and vomiting (PONV), and delayed return of gastrointestinal function. That being said, rescue opioids should always be available if patients are in pain. All of the above opioid-related side effects are dose dependent, with minimization of opioid use being more important than avoidance: Limited use of IV opioids has little effect on outcome. 33
ΔSV2
ΔSV1
Postoperative Components
VC1
VC2
Intravascular Volume Figure 1. Frank-Starling-based stroke volume optimization. When a patient is hypovolemic and on the steeper ascending part of the Frank-Starling curve, an IV fluid challenge (VC1) will lead to a 10% increase in SV. Such a patient has “recruitable” SV, and is in a fluid-responsive state. When the patient is no longer hypovolemic (VC2), the same fluid challenge will result in an increase of less than 10% in SV. The patient is now not fluid responsive and will not benefit from a further fluid challenge. SV, stroke volume; VC, intravascular volume challenge
4
Multimodal analgesia should consist of regular acetaminophen and nonsteroidal anti-inflammatory drugs unless contraindicated; this should be initiated preoperatively and continued postoperatively as needed. Other drugs that can be used as part of a multimodal regimen include the gabapentinoids (gabapentin, pregabalin), N-methyl-D-aspartate receptor antagonists (ketamine), α 2 agonists (clonidine, dexmedetomidine), local anesthetic infiltration, and IV lidocaine. Additionally, regional anesthesia should be used whenever possible as part of a pain management strategy. For open surgery, thoracic epidural anesthesia (TEA) is well established as the optimal regional analgesic technique. When functioning well, TEA offers excellent analgesia for the first 72 hours, and it is therefore considered the gold standard for open surgery.34 However, TEAs have potential to cause harm. Patients with a poorly working TEA often are denied other analgesia and can be in considerable pain.35 TEA also can cause hypotension (often treated with fluid) that complicates fluid management, as well as delayed mobilization and urinary catheter removal. Thus, it is essential that TEA be managed by a dedicated pain service. For laparoscopic surgery, the advantages of TEA are less clear. Some studies support its use because patients undergoing laparoscopic surgery still experience a considerable amount of visceral pain10 ; yet, others suggest that it is unnecessary and that the disadvantages outweigh the advantages.33 It is probably the case that there is no gold standard technique for laparoscopic surgery. For extensive laparoscopic surgery in a patient at high risk for pulmonary complications, TEA may offer advantages over other techniques.36 For more routine laparoscopic surgery, alternative techniques should be considered such as intrathecal (spinal) analgesia, paravertebral blocks, transversus abdominis plane blocks, and local anesthesia in the wound, all combined with multimodal analgesia.
Successful implementation of the preoperative and intraoperative elements of an ERAS pathway enables mobilization and feeding to occur on the day of surgery. Patients are encouraged to sit on a chair for at least 6 hours on every postoperative day. Only evidence-based use of drains, catheters, or nasogastric tubes is applied. This intentionally directed early return to normal function reduces the complications associated with starvation and immobility. Allowing early feeding decreases the incidence of ileus and negates the need for postoperative intravenous fluid. Avoiding postoperative fluid overload continues to be as important as fluid management intraoperatively; however, this can be a greater challenge on the surgical ward without monitors or fluid management strategies. Allowing for the responses to trauma of surgery and the natural normalization of these responses is an important postoperative management consideration. Some extent of permissive oliguria until decreases in antidiuretic
REPORT hormone or permissive relative hypotension (within 10-15 systolic points of baseline), while peripheral tone is decreased with a thoracic epidural, will allow for minimal fluid infusion when not needed.37 These strategies are challenges with the multitude of care providers over the first 36 to 72 hours, emphasizing the need for enthusiastic teaching of all providers and involved learners. The most enthusiastic early adopters of ERAS principles in the United States have been surgeons with aggressive rehabilitation postoperative protocols. These practitioners were predominantly early adopters of laparoscopic colorectal surgery and referred to their postoperative care pathways as “fast track.” These pathways have continued to evolve to include more elements as more interventions are studied. The majority of debated postoperative elements are related to bowel function, as the common end point of LOS is driven by return of bowel function. Chewing gum, laxative use, and the peripheral mu-opioid inhibitor are used in many protocols. These individual components have been proven safe and variably effective. Of all the postoperative elements affecting outcomes, especially resource use and costs, preoperative education of discharge criteria and postoperative adherence to defined criteria is paramount. A patient that successfully tolerates the stress of surgery, due to all the implemented care elements, but is not successfully discharged at this time is subject to in-hospital complications and does not obtain the full benefit of the protocol.38-41
The importance of team and patient education is essentially stressed in terms of discharge. One point of presumed failure of enhanced recovery care could be readmission. At times interpreted as being caused by premature discharge from the hospital, readmission following ERAS is usually due to complication(s); however, if patient education is lacking, the anxious or uneducated patient may use the postoperative clinic or emergency room for answers. These visits happen with greatest frequency in the first 30 days after index hospital stay and certainly affect the metrics of interest for ERAS programs. Of note, it has been shown that shorter hospital stays in an ERP are not associated with increased readmission. Rather, longer index stays are associated with greater readmission rates, confirming the etiology of readmission to be related to surgical complications.42
Evidence of Benefit The most recent meta-analysis of ERAS pathways in colorectal surgery included 2,376 patients in 16 RCTs, and showed that ERAS pathways were associated with a reduction of overall morbidity (relative risk [RR]=0.60; 95% confidence interval [CI], 0.46-0.76), particularly with respect to nonsurgical complications (RR = 0.40; 95% CI, 0.27-0.61).43 The ERAS pathway also resulted in a shortened hospital LOS (weighted mean difference, –2.28 days; 95% CI, –3.09 to –1.47), without increasing the readmission rate. Implementation of ERPs, however, is a complex process that affects multiple departments in a hospital and requires
Give more opioids
Breakthrough Pain
Opioids
Potent opioids
Moderate to Severe Pain
Neural blockade, ketamine
Weak opioids
Mild to Moderate Pain
Acetaminophen, COX-2 inhibitors, NSAIDs, gabapentanoids, IV lidocaine, local anesthetic infiltration
Figure 2. Opioid monotherapy versus multimodal analgesia. COX-2, cyclooxygenase-2; NSAIDs, nonsteroidal anti-inflammatory drugs
5
REPORT collaboration between surgery, anesthesia, nursing, and hospital management. Most implementation cycles take 3 to 6 months and are multifaceted, and therefore are not ideally suited for an RCT. There also are a number of quality improvement projects showing similar benefits—the largest being the implementation of the NHS Enhanced Recovery Partnership Program in the United Kingdom.44 It also is important to note that published studies to date that evaluate the outcome benefit of ERPs have focused on short-term benefits. Patients, however, do not define recovery as being healed physically; instead, they consider recovery as “the absence of symptoms and return of their ability to perform activities as they could prior to surgery.”45 This rehabilitation period can last much longer than health care providers expect. In a study of patients older than age 60 years undergoing elective abdominal surgery, less than 50% of patients had recovered to baseline levels of physical performance 6 months after surgery, and 20% were still unable to perform basic activities of daily living (ADLs).46 Thus, future studies should also examine long-term outcomes with return to normal function considered the benchmark for recovery after major surgery.47
Moving Beyond Colorectal Surgery The principles of ERPs apply to all patients undergoing major surgery, and probably all patients admitted to a hospital. There are now international guideline groups developing guidelines across all surgical specialties, and so far, evidence-based guidelines have been published or are being developed for pancreatectomy,48 gastric resection,49 cystectomy,50 pelvic/ rectal surgery,51 gynecologic procedures, and esophagectomy. In 2012, the United Kingdom’s Enhanced Recovery consensus statement stated that “enhanced recovery should now be considered standard practice for most patients undergoing major surgery across a range of procedures and specialities.”44
Recent data suggest that at least 30% of patients over age 70 and hospitalized with a medical illness (eg, pneumonia) are discharged with a new hospitalization-associated disability (defined as a new loss of ability to perform at least one ADL) that was not present before the onset of illness52; factors such as prolonged bed rest; malnutrition; and overuse of lines, monitors, urinary catheters, and sedating medications are thought to contribute significantly to loss of function.53
The Economic Effect of ERPs There is considerable economic benefit in the implementation of ERPs that is related to both the reduction in hospital LOS and complications.11 The most recent meta-analysis showed that ERPs shorten hospital LOS by approximately 2.3 days.43 This will result in a significant reduction in hospital costs, and also has added clinical and economic advantages to the institution by making hospital beds available for patients undergoing other procedures. ERPs also reduce complications by approximately 40%,43 and consequently reduced associated expenses. In a recent study of 74,140 patients undergoing major non-cardiac surgery, the average cost difference between patients with and without complications was $29,876.54 In an era of pay-for-performance programs and economic constraints, a program that improves the quality of health care while reducing costs is obviously very attractive to health care providers, administrators, and patients.
Conclusion ERPs are multimodal perioperative care protocols that apply evidence-based medicine to every step of a patient’s perioperative period, and have been shown to reduce LOS and associated complications after colorectal surgery. ERPs should be considered as the new standard of care for patients undergoing elective colorectal resection. Additional studies are needed to support the use of ERPs in other major surgery.
The American Society for Enhanced Recovery (ASER) was officially founded in 2014. It is a nonprofit organization with an international membership, which is dedicated to promote the practice of enhanced recovery in the perioperative patients through education and research. ASER’s mission is to advance the practice of perioperative enhanced recovery, and to contribute to its growth and influences by fostering and encouraging research, education, public policy discussion, and scientific progress.
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Muller S, Zalunardo MP, Hubner M, et al. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. y 2009;136(3):842-847.
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Serclová Z, Dytrych P, Marvan J, et al. Fast-track in open intestinal surgery: prospective randomized study (ClinicalTrials.Gov Identifier no. NCT00123456). Clin Nutr. r 2009;28(6):618-624.
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Guenaga KK, Matos D, Wille-Jørgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2009;1:CD001544.
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Lobo DN, Bostock KA, Neal KR, et al. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet. 2002; 359(9320):1812-1818.
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Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007:CD004929.
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Awad S, Constantin-Teodosiu D, Macdonald IA, et al. Short-term starvation and mitochondrial dysfunction—a possible mechanism leading to postoperative insulin resistance. Clin Nutr. r 2009;28(5):497-509.
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Sultan P, Hamilton MA, Ackland GL. Preoperative muscle weakness as defined by handgrip strength and postoperative outcomes: a systematic review. BMC Anesthesiol. 2012;12:1. Khuri SF, Henderson WG, DePalma RG, VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005;242(3):326-341; discussion 41-43.
10. Miller TE, Thacker JK, White WD, et al; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014;118(5):1052-1061. 11. Gustafsson UO, Scott MJ, Schwenk W, et al; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS® ) Society recommendations. Clin Nutr. r 2012;31(6):783-800. 12. Fearon KC, Ljungqvist O, Von Meyenfeldt M, et al. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. r 2005; 24(3):466-477. 13. Mondloch MV, Cole DC, Frank JW. Does how you do depend on how you think you’ll do? A systematic review of the evidence for a relation between patients’ recovery expectations and health outcomes. CMAJ. 2001;165(2):174-179. 14. Cohen ME, Bilimoria KY, Ko CY, et al. Development of an American College of Surgeons National Surgery Quality Improvement Program: morbidity and mortality risk calculator for colorectal surgery. J Am Coll Surg. 2009;208(6):1009-1016. 15. Pearse RM, Moreno RP, Bauer P, et al; European Surgical Outcomes Study group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012;380(9847):1059-1065.
16. Finlayson E, Zhao S, Boscardin WJ, et al. Functional status after colon cancer surgery in elderly nursing home residents. J Am Geriatr Soc. 2012;60(5):967-973. 17. Lindström D, Sadr Azodi O, Wladis A, et al. Effects of a perioperative smoking cessation intervention on postoperative complications: a randomized trial. Ann Surg. 2008;248(5):739-745. 18. O’Doherty AF, West M, Jack S, et al. Preoperative aerobic exercise training in elective intra-cavity surgery: a systematic review. Br J Anaesth. 2013;110(5):679-689. 19. Snowden CP, Prentis JM, Anderson HL, et al. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010;251(3):535-541. 20. American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. y 2011;114(3):495-511. 21. Nygren J. The metabolic effects of fasting and surgery. Best Pract Res Clin Anaesthesiol. 2006;20(3):429-438. 22. Gustafsson UO, Nygren J, Thorell A, et al. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008;52(7):946-951. 23. Guenaga KF, Matos D, Castro AA, Atallah AN, Wille-Jorgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. v 2003;1:CD001544. 24. Mahajna A, Krausz M, Rosin D, Shabtai M, Hershko D, Ayalon A, Zmora O. Bowel preparation is associated with spillage of bowel contents in colorectal surgery. Dis Colon Rectum. 2005;48(8): 1626-1631. 25. Slim K, Vicaut E, Launay-Savary MV, et al. Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg. 2009;249(2):203-209. 26. Vlug MS, Wind J, Hollmann MW, et al; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011;254(6):868-875. 27. Jacob M, Chappell D, Rehm M. The ‘third space’—fact or fiction? Best Pract Res Clin Anaesthesiol. 2009;23(2):145-157. 28. Chappell D, Jacob M, Hofmann-Kiefer K, et al. A rational approach to perioperative fluid management. Anesthesiology. y 2008;109(4):723-740. 29. Mythen MG, Swart M, Acheson N, et al. Perioperative fluid management: Consensus statement from the enhanced recovery partnership. Perioper Med (Lond). 2012;1:2. 30. Pearse RM, Harrison DA, MacDonald N, et al; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014;311(21):2181-2190. 31. Srinivasa S, Taylor MH, Singh PP, et al. Randomized clinical trial of goal-directed fluid therapy within an enhanced recovery protocol for elective colectomy. Br J Surg. 2013;100(1):66-74.
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REPORT 32. White PF, Kehlet H, Neal JM, et al. The role of the anesthesiologist in fast-track surgery: from multimodal analgesia to perioperative medical care. Anesth Analg. 2007;104(6):1380-1396, table of contents. 33. Levy BF, Scott MJ, Fawcett W, et al. Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery. Br J Surg. 2011;98(8): 1068-1078. 34. Werawatganon T, Charuluxanun S. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. Cochrane Database Syst Rev. 2005;1:CD004088. 35. Hermanides J, Hollmann MW, Stevens MF, et al. Failed epidural: causes and management. Br J Anaesth. 2012;109(2):144-154. 36. Pöpping DM, Elia N, Marret E, et al. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008;143(10):990-999; discussion 1000. 37. Miller TE, Roche AM, Mythen M. Fluid management and goaldirected therapy as an adjunct to Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2014 Nov 13. [Epub ahead of print] 38. Keller D, Stein SL. Facilitating return of bowel function after colorectal surgery: alvimopan and gum chewing. Clin Colon Rectal Surg. 2013;26(3):186-190. 39. Hendry PO, van Dam RM, Bukkems SF, et al; Enhanced Recovery After Surgery (ERAS) Group. Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection. Br J Surg. 2010;97(8):1198-1206. 40. Ho YM, Smith SR, Pockney P, et al. A meta-analysis on the effect of sham feeding following colectomy: should gum chewing be included in enhanced recovery after surgery protocols? Dis Colon Rectum. 2014;57(1):115-126. 41. Vaughan-Shaw PG, Fecher IC, Harris S, et al. A meta-analysis of the effectiveness of the opioid receptor antagonist alvimopan in reducing hospital length of stay and time to GI recovery in patients enrolled in a standardized accelerated recovery program after abdominal surgery. Dis Colon Rectum. 2012;55(5):611-620. 42. Lawrence JK, Keller DS, Samia H, et al. Discharge within 24 to 72 hours of colorectal surgery is associated with low readmission rates when using Enhanced Recovery Pathways. J Am Coll Surg. 2013;216(3):390-394.
43. Greco M, Capretti G, Beretta L, et al. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014;38(6):1531-1541. 44. NHS Enhanced Recovery Care Pathway. http://www.nhsiq.nhs. uk/8846.aspx. Accessed November 3, 2014. 45. Kleinbeck SV, Hoffart N. Outpatient recovery after laparoscopic cholecystectomy. AORN J. 1994;60(3):394, 397-398, 401-402. 46. Lawrence VA, Hazuda HP, Cornell JE, et al. Functional independence after major abdominal surgery in the elderly. J Am Coll Surg. 2004;199(5):762-772. 47. Miller TE, Mythen M. Successful recovery after major surgery: moving beyond length of stay. Perioper Med (Lond). 2014;3:4. 48. Lassen K, Coolsen MM, Slim K, et al; ERAS Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS® ) Society recommendations. Clin Nutr. r 2012;31(6):817-830. 49. Mortensen K, Nilsson M, Slim K, et al; Enhanced Recovery After Surgery (ERAS®) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Br J Surg. 2014;101(10): 1209-1229. 50. Cerantola Y, Valerio M, Persson B, et al. Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS® ) society recommendations. Clin Nutr. 2013;32(6):879-887. 51. Nygren J, Thacker J, Carli F, et al; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/ pelvic surgery: Enhanced Recovery After Surgery (ERAS® ) Society recommendations. Clin Nutr. r 2012;31(6):801-816. 52. Covinsky KE, Pierluissi E, Johnston CB. Hospitalization-associated disability: “She was probably able to ambulate, but I’m not sure.” JAMA. 2011;306(16):1782-1793. 53. Ettinger WH. Can hospitalization-associated disability be prevented? JAMA. 2011;306(16):1800-1801. 54. Manecke GR, Asemota A, Michard F. Tackling the economic burden of postsurgical complications: would perioperative goaldirected fluid therapy help? Crit Care. 2014;18(5):566. [Epub ahead of print]
World Congress of Enhanced Recovery After Surgery and Perioperative Medicine May 9-12, 2015 • Washington, DC For more information, visit www.enhancedrecovery.org
Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, the American Society for Enhanced Recovery, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2014, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.
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Disclosures: Dr. Gan reported that he has received grant support from AcelRx and Fresenius Kabi, and is a consultant for Baxter, Covidien, Edwards Lifesciences, Mallinckrodt, and Pacira. Dr. Miller reported that he has received honoraria from Edwards Lifesciences and research funding from Covidien Dr. Thacker reported that she is a consultant for Cheetah Medical, Covidien, Edwards Lifesciences, and Premier Data.