Incidence Of Opioid-related Adverse Events Research Articles

Effects of goal-directed analgesia using the analgesia nociception index in children undergoing surgery for moyamoya disease: A randomised controlled trial.

The potential benefits of Analgesia Nociception Index guided intra-operative analgesia on intra-operative opioid consumption remains to be demonstrated in paediatric anaesthesia. This study aimed to explore the effects of Analgesia Nociception Index guided analgesia on sufentanil consumption during anaesthesia and postoperative pain scores in paediatric patients with moyamoya disease. A prospective randomised controlled study. Seoul National University Children's Hospital, Seoul, Republic of Korea. A total of 40 children scheduled for encephaloduroarteriosynangiosis. The primary outcome was total intra-operative sufentanil consumption, and the secondary outcomes included postoperative pain scores and incidence of opioid-related adverse events. The Analgesia Nociception Index group showed lower intra-operative sufentanil consumption (in μg kg-1 h-1) compared with the Standard group (0.30 ± 0.12 and 0.39 ± 0.17, respectively; mean difference, -0.09; 95% confidence interval, -0.19 to 0.00; P = 0.049). Postoperatively, compared with the Standard group, the Analgesia Nociception Index group reported lower median pain scores at 18 and 24 h and maximum pain within 24 h (1 [0 to 2] vs. 3 [2 to 5]; P = 0.004, 1 [0 to 2] vs. 3 [1 to 4]; P = 0.041, and 4 [3 to 5] vs. 5 [4 to 7]; P = 0.045, respectively), with fewer patients experiencing nausea (3 [15%] vs. 10 [50%], P = 0.043). The Analgesia Nociception Index guided analgesic protocol can reduce intra-operative sufentanil consumption and postoperative pain within 24 h with fewer nausea symptoms in paediatric patients with moyamoya disease who undergo encephaloduroarteriosynangiosis. NCT05672212 (registered at clinicaltrials, principal investigator: K.E.H., registration date: 2 January 2023).

Tapentadol Versus Oxycodone for Opioid-Related Adverse Drug Events and Clinical Outcomes After Inpatient Surgery

Oxycodone is a commonly prescribed opioid for postoperative pain. However, there has been a marked increase in the use of tapentadol over the previous decade due to a perceived superior safety profile of tapentadol compared to oxycodone. There is limited real-world evidence on the safety of tapentadol compared to oxycodone after surgery. The primary objective was to examine the impact of tapentadol compared to oxycodone use on the incidence of opioid-related adverse drug events after surgery. Data for adult surgical patients receiving tapentadol or oxycodone during hospitalization between January 1, 2018, and December 31, 2021, were collected from electronic medical records of 3 tertiary metropolitan hospitals in Australia. The primary outcome was the incidence of opioid-related adverse events. Patients receiving tapentadol or oxycodone were matched using nearest-neighbour propensity score matching. In the matched cohorts (n = 1,530 vs n = 2,775; mean [standard deviation] age 62.3 [17.0] years vs 61.9 [standard deviation 17.9] years; 43% vs 45% male for the tapentadol vs oxycodone groups, respectively), patients given tapentadol experienced a similar incidence of adverse events overall (14.4%, 220/1,530 vs 12.6%, 349/2,775; P = .100; 95% CI −.35% to 3.95%). Secondary outcomes included an increased risk of delirium (2.7%, 41/1,530 vs 1.3%, 37/2,775), arrhythmias (3.4%, 52/1,530 vs 2.2%, 62/2,775), and length of hospital stay (5 [range 1–201] vs 4 [range 1–226] days) compared with oxycodone use. Further real-world studies are warranted to determine the impact of tapentadol use on a broad range of patient outcomes. PerspectiveThis study provides an early signal that tapentadol use may be associated with an increased risk of some adverse events and a longer length of stay. Further research is needed to examine the impact of tapentadol use on a broad range of patient outcomes in clinical practice settings.

The incidence of opioid misuse among the surgical patients with persistent opioid use.

To calculate the monthly incidence of opioid-related adverse events in the opioid-naïve patients who contin-ue to use opioids in the post-operative period. An estimate of 1-6 percent of surgery patients con-tinues to persistently use the opioids longer than 90 post-operative days. However, the association of the opioid ad-verse events with the persistent post-operative use is not clearly known. This is a historical (retrospective) cohort study of the opioid-naïve US Veterans between the ages of 18 and 85. The surgical group (who had major surgery between January 1, 2008 and December 31, 2015) was compared to the control references. The outcome of opioid misuse was either opioid overdose or the development of opioid use disorder. Each case was followed for 13 months. The monthly incidence of opioid misuse was calculated by dividing the number of new opioid misuse divided by the number of patients who are still filling the prescription for opioid medications in that specific month. A total of 150,088 surgical patients and 1,145,553 controls met the inclusion criteria. The risk of opioid misuse was between 0.3 and 1.8 percent for first 11 post-operative months among both groups. The incidence of opioid misuse increases to 4.6 percent (95 percent CI: 3.2-6.4) at 12 months and to 8.1 percent (95 percent CI: 5.6-11.5) at 13th post-operative month. The incidence also increases to 2.3 percent (95 percent CI: 1.6-3.4) at 12th and 3.9 percent (95 percent CI: 2.5-6.0) at 13th follow-up month among the control references. After initiation of opioid pre-scription, the opioid misuse occurs, and the incidence increases dramatically after the 11th month regardless of the reason for opioid therapy initiation (surgery vs chronic conditions). The risks/-benefits of opioid use must be evaluated more frequently with the longer opioid use.

Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain.

Prolonged-release (PR; as ascribed in the EU) or extended-release (as ascribed in the USA) bupivacaine/meloxicam (HTX-011; hereafter referred to as bupivacaine/meloxicam PR; Zynrelef®) is a synergistic fixed-dose combination (FDC) of the local anaesthetic bupivacaine and the NSAID meloxicam. It is approved in the EU and the USA to treat postoperative pain. After needle-free application at the surgical site, the novel polymer technology allows simultaneous diffusion of bupivacaine and meloxicam over 72h. In clinical trials, bupivacaine/meloxicam PR significantly reduced postoperative pain and opioid consumption relative to bupivacaine hydrochloride (HCl) and placebo in patients undergoing bunionectomy, herniorrhaphy or total knee arthroplasty (TKA). When used as the foundation of a scheduled non-opioid multimodal analgesia (MMA) regimen, bupivacaine/meloxicam PR further improved pain control and reduced the need for opioids following surgery. Bupivacaine/meloxicam PR was generally well tolerated, with a lower incidence of opioid-related adverse events than bupivacaine HCl and placebo. Although additional data would be beneficial, current evidence indicates that bupivacaine/meloxicam PR is a promising non-opioid treatment option for the management of postoperative pain.

Impact of an Australian/New Zealand organisational position statement on extended-release opioid prescribing among surgical inpatients: a dual centre before-and-after study.

Extended-release opioids are often prescribed to manage postoperative pain despite being difficult to titrate to analgesic requirements and their association with long-term opioid use. An Australian/New Zealand organisational position statement released in March 2018 recommended avoiding extended-release opioid prescribing for acute pain. This study aimed to evaluate the impact of this organisational position statement on extended-release opioid prescribing among surgical inpatients. Secondary objectives included predictors and clinical outcomes of prescribing extended-release opioids among surgical inpatients. We conducted a retrospective, dual centre, 11-month before-and-after study and time-series analysis by utilising electronic medical records from two teaching hospitals in Sydney, Australia. The primary outcome was the proportion of patients prescribed an extended-release opioid. For surgical patients prescribed any opioid (n = 16,284), extended-release opioid prescribing decreased after the release of the position statement (38.4% before vs. 26.6% after, p < 0.001), primarily driven by a reduction in extended-release oxycodone (31.1% before vs. 14.1% after, p < 0.001). There was a 23% immediate decline in extended-release opioid prescribing after the position statement release (p < 0.001), followed by an additional 0.2% decline per month in the following months. Multivariable regression showed that the release of the position statement was associated with a decrease in extended-release opioid prescribing (OR 0.54, 95%CI 0.50-0.58). Extended-release opioid prescribing was also associated with increased incidence of opioid-related adverse events (OR 1.52, 95%CI 1.35-1.71); length of stay (RR 1.44, 95%CI 1.39-1.51); and 28-day re-admission (OR 1.26, 95%CI 1.12-1.41). Overall, a reduction in extended-release opioid prescribing was observed in surgical inpatients following position statement release.

Post-Operative Pain Management in Lung Transplant Recipients: A Focus on Opioid Use

Purpose Effective management of post-operative pain in lung transplant recipients (LTR) can be challenging. LTR are highly vulnerable to opioid related adverse effects such as sedation, respiratory depression and gastrointestinal side effects. While systemic opioids have traditionally been used as the mainstay of post-operative pain management, there is now heightened awareness of their harmful effects. Internationally, increasing opioid prescriptions has corresponded with an increase in opioid abuse, adverse events and hospital admissions. In addition, the Australian and New Zealand College of Anaesthetists recently released a position statement recommending against the use of slow-release opioids in the management of patients with acute pain. The patterns of opioid use following lung transplantation (LT) have not been well described in the literature. This study examined the prescribing patterns at our centre including the type of opioid and non-opioid analgesia used, the length of opioid use and rates of opioid associated adverse events following LT. Methods We undertook a single center retrospective analysis of 56 patients undergoing LT from 2016 to 2019. Post-operative pain relief regimens were examined including opioid and non-opioid modalities used in the ICU, at hospital discharge, at 6 weeks, 3 months and 6 months following LT. The incidence of opioid related adverse events was examined. Results There was a large variation in analgesic modalities used in the immediate post-operative period. Thoracic epidural analgesia was used in 37.5% and extra-pleural catheters were used in 3.6%. The use of opioid analgesia was 100% in the ICU, 66.1% at discharge from hospital, 46.4% at 6 weeks, 8.9% at 3 months and 1.8% at 6 months. Opioid related adverse effects occurred in 17.9%. LTR who were prescribed long acting opioids in the ICU had a higher incidence of opioid-related adverse events (RR 3.27, 95% CI 1.05 - 10.21). Conclusion The majority of LTR have ceased opioid medication use by 3 months. The high incidence of early opioid related adverse events highlights the need to reduce early systemic opioid use. The development of a standardized approach to pain management could be considered and increased use of regional modalities could be used. Long acting opioids were linked to greater harm and their use should be minimized.

Current Status of Adverse Events Related with Opioid Analgesics in Japan: Assessment Based on Japanese Adverse Drug Event Report Database.

Opioid analgesics have greatly contributed to the advancement of pain management. However, although opioids have been appropriately used in Japan, they rarely induce serious adverse events, such as respiratory depression. The present study aimed to investigate the temporal changes in the occurrence of opioid-related adverse events and deaths between 2004 and 2017 in Japan using the Japanese Adverse Drug Event Report (JADER) database. We analyzed the following points using data extracted from JADER website: 1) temporal changes in the number and proportion of opioid-related adverse event reports; 2) temporal changes in the number of morphine-, oxycodone-, and fentanyl-related adverse event reports per annual consumption; and 3) cases in which the reported outcome following opioid-related adverse events was death. Our results showed no dramatic changes in the overall incidence of opioid-related adverse events, despite the temporal changes in the annual consumption and shared component of each opioid during the survey period. However, the number and rate of fentanyl-related adverse events and their outcome "death" increased since 2010, being the highest among all adverse event including those related to morphine and oxycodone. Outcome "death" by fentanyl-related adverse events was caused mainly due to respiratory depression. These findings suggest that, although opioid-related adverse events can be controlled through proper monitoring and management by medical personnel in Japan, extra caution should be continuously paid for the rare but serious fentanyl-induced adverse events.

Long-term treatment patterns of prophylactic and acute migraine medications and incidence of opioid-related adverse events in patients with migraine.

To describe long-term treatment patterns in migraine patients initiating prophylactic therapy and to evaluate acute medication use and adverse events associated with opioids. This study used the 2005-2014 IBM MarketScan® databases to evaluate migraine patients initiating prophylactic medication. Outcome measures included persistence with prophylactic migraine medications over 2-5 years. Acute medication use and gastrointestinal-related adverse events and opioid abuse following opioid use were evaluated. Cox proportional hazards models were used to evaluate predictors of non-persistence and predictors of gastrointestinal-related AEs and opioid abuse associated with long-term opioid use. In total, 147,832 patients were analyzed. Non-persistence was observed in 90% of patients; 39% switched, 30% restarted, and 31% discontinued treatment. Over the follow-up, 59.9% of patients received triptans, 66.6% non-steroidal anti-inflammatory drugs, 77.4% opioids, and 2.6% ergotamines. Among opioid users, 16.6% experienced nausea/vomiting, 12.2% had constipation, and 10.4% had diarrhea. Opioid abuse was reported in <1% of opioid users. Gastrointestinal-related adverse events increased with increasing number of days' supply of opioids. Non-persistence to prophylactic treatment was frequent among migraine patients. Opioid use was common in migraine patients and the risk of gastrointestinal-related adverse events and opioid abuse increased with long-term use of opioids. These results suggest a need for more effective prophylactic migraine treatments.

Outpatient Opioid Prescriptions for Children and Opioid-Related Adverse Events.

Little is known about opioid prescribing for children without severe conditions. We studied the prevalence of and indications for outpatient opioid prescriptions and the incidence of opioid-related adverse events in this population. This retrospective cohort study between 1999 and 2014 included Tennessee Medicaid children and adolescents aged 2 to 17 without major chronic diseases, prolonged hospitalization, institutional residence, or evidence of a substance use disorder. We estimated the annual prevalence of outpatient opioid prescriptions and incidence of opioid-related adverse events, defined as an emergency department visit, hospitalization, or death related to an opioid adverse effect. There were 1 362 503 outpatient opioid prescriptions; the annual mean prevalence of opioid prescriptions was 15.0%. The most common opioid indications were dental procedures (31.1% prescriptions), outpatient procedure and/or surgery (25.1%), trauma (18.1%), and infections (16.5%). There were 437 cases of opioid-related adverse events confirmed by medical record review; 88.6% were related to the child's prescription and 71.2% had no recorded evidence of deviation from the prescribed regimen. The cumulative incidence of opioid-related adverse events was 38.3 of 100 000 prescriptions. Adverse events increased with age (incidence rate ratio = 2.22; 95% confidence interval, 1.67-2.96; 12-17 vs 2-5 years of age) and higher opioid doses (incidence rate ratio = 1.86 [1.45-2.39]; upper versus lower dose tertiles). Children without severe conditions enrolled in Tennessee Medicaid frequently filled outpatient opioid prescriptions for acute, self-limited conditions. One of every 2611 study opioid prescriptions was followed by an opioid-related adverse event (71.2% of which were related to therapeutic use of the prescribed opioid).

Pentazocine versus pentazocine with piroxicam for postoperative pain relief after cesarean section: an open label, comparative study

Background: The concept of multimodal analgesia was introduced more than a decade ago as a technique to improve analgesia and reduce the incidence of opioid-related adverse events. The rationale for this strategy is the achievement of sufficient analgesia due to the additive or synergistic effects between different classes of analgesics. Objectives of the study was to compare the efficacy and safety of pentazocine and its combination with piroxicam in the management of post cesarean pain.Methods: Cases were randomly assigned to 2 groups of 30 cases each. One group received pentazocine 30mg and another; pentazocine 30mg + piroxicam 20mg. Injections were given intramuscularly, postoperatively after skin closure. Diclofenac 75mg was the rescue analgesia. Primary outcome measure was control of pain, assessed by visual analogue scale (VAS). Secondary outcomes were sedation and time to rescue analgesia. Safety of the drugs was assessed by adverse drug reactions. Data was analysed by student’s t test, analysis of variance and post-hoc test.Results: Multimodal group showed better analgesia compared to unimodal group (p&lt;0001). Drowsiness was the main adverse effect in both treatment groups.Conclusions: Multimodal analgesic combination of pentazocine and piroxicam showed superior analgesic effect with better pain control and longer duration of action compared to pentazocine alone.

Fentanyl Iontophoretic Transdermal System: A Review in Acute Postoperative Pain.

Fentanyl iontophoretic transdermal system (ITS) [Ionsys(®)] is indicated for the management of acute postoperative pain in adults requiring opioid analgesia in the hospital setting. This article reviews the clinical use of fentanyl ITS for postoperative pain management, and summarizes the pharmacology of fentanyl and the characteristics of the two-component fentanyl ITS (Ionsys(®)) device. In well-designed, multicentre clinical trials, fentanyl ITS was an effective and generally well tolerated method for managing acute postoperative pain in inpatients who had undergone major abdominal, thoracic or orthopaedic surgery. Overall, fentanyl ITS provided equivalent analgesic efficacy to that with morphine patient-controlled intravenous analgesia (PCIA), but was perceived to be more convenient/easier to use than morphine PCIA by patients, nurses and physical therapists. Patients receiving fentanyl ITS also had a greater ability to mobilize after surgery than patients receiving morphine PCIA. In addition, relative to morphine PCIA, fentanyl ITS offers advantages in terms of the noninvasive administrative route (i.e. transdermal needle-free administration), pre-programmed delivery (no risk of programming errors/incorrect dosing) and improved tolerability with regard to the overall incidence of opioid-related adverse events (ORAEs) and some individual ORAEs. Hence, fentanyl ITS is a useful option for the management of acute postoperative pain in adults requiring opioid analgesia in the hospital setting.

Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients.

BackgroundAchieving adequate control of postsurgical pain remains a challenge in patients undergoing abdominal surgery. Transversus abdominis plane (TAP) infiltration has been shown to provide postsurgical analgesia following lower abdominal surgery. We assessed the safety and efficacy of a prolonged-release liposomal formulation of the local anesthetic bupivacaine administered via infiltration into the TAP in a cohort of patients undergoing open abdominal umbilical hernia repair.MethodsPatients included in the study were 18–75 years of age, had American Society of Anesthesiologists physical classification status 1–3, and underwent open abdominal umbilical hernia repair with ultrasound-guided TAP infiltration immediately after surgery using an equal-volume bilateral infusion of liposomal bupivacaine 266 mg (diluted to 30 mL in normal saline). Outcome measures included patient-reported pain intensity (11-point numeric rating scale), satisfaction with postsurgical analgesia (5-point Likert scale), incidence of opioid-related adverse events, and time to first use of supplemental rescue analgesia.ResultsThirteen patients underwent surgery and received bilateral TAP infiltration with liposomal bupivacaine; TAP infiltration failed in the first patient. Mean numeric rating scale pain scores were 0.6 immediately before TAP infiltration and remained ≤2.3 through 120 hours after infiltration; mean scores at 120 hours and 10 days were 0.9 and 0.4, respectively. Ten patients (77%) required supplemental analgesia; median time to first use was 11 hours. At discharge and day 10, 54% and 62% of patients, respectively, were “extremely satisfied” with postsurgical analgesia (Likert score 5). There were no opioid-related or other adverse events.ConclusionAlthough the current study was limited by both its lack of a control group and its small size, to our knowledge, it is the first published report on use of liposomal bupivacaine for TAP infiltration. In this cohort, liposomal bupivacaine was observed to be well tolerated with encouraging analgesic efficacy.

An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal

BackgroundOpioid analgesics are effective for postsurgical pain but are associated with opioid-related adverse events, creating a significant clinical and economic burden. Gastrointestinal surgery patients are at high risk for opioid-related adverse events. We conducted a study to assess the impact of an opioid-sparing multimodal analgesia regimen with liposome bupivacaine, compared with the standard of care (intravenous [IV] opioid-based, patient-controlled analgesia [PCA]) on postsurgical opioid use and health economic outcomes in patients undergoing ileostomy reversal.MethodsIn this open-label, multicenter study, sequential cohorts of patients undergoing ileostomy reversal received IV opioid PCA (first cohort); or multimodal analgesia including a single intraoperative administration of liposome bupivacaine (second cohort). Rescue analgesia was available to all patients. Primary outcome measures were postsurgical opioid use, hospital length of stay, and hospitalization costs. Incidence of opioid-related adverse events was also assessed.ResultsTwenty-seven patients were enrolled, underwent the planned surgery, and did not meet any intraoperative exclusion criteria; 16 received liposome bupivacaine-based multimodal analgesia and eleven received the standard IV opioid PCA regimen. The multimodal regimen was associated with significant reductions in opioid use compared with the IV opioid PCA regimen (mean, 20 mg versus 112 mg; median, 6 mg versus 48 mg, respectively; P < 0.01), postsurgical length of stay (median, 3.0 days versus 5.1 days, respectively; P < 0.001), and hospitalization costs (geometric mean, $6482 versus $9282, respectively; P = 0.01).ConclusionA liposome bupivacaine-based multimodal analgesic regimen resulted in statistically significant and clinically meaningful reductions in opioid consumption, shorter length of stay, and lower inpatient costs than an IV opioid-based analgesic regimen.

Intravenous Acetaminophen

Hospitals are subject to more economic pressures than ever before. On the one hand, cost containment or cost reduction is paramount, particularly in relation to costly branded pharmaceuticals. On the other hand, quality measures and value-based reimbursement penalizes poor patient care. Multimodal analgesia sits squarely in this quandary, since its very nature requires use of multiple drugs with their associated costs, though this approach has the potential to improve quality of care. We undertook a comprehensive review of the pharmacoeconomics of IV acetaminophen, a new drug useful as part of a multimodal analgesic approach. While this new branded drug adds to direct drug costs, there is clear potential for IV acetaminophen to reduce the incidence of opioid-related adverse events and, in so doing, result in net hospital savings. This review describes many clinical studies showing significant improvements in postoperative nausea and vomiting, excessive sedation and pruritus. In addition, we describe studies demonstrating faster recovery times in the post-anesthesia care unit, intensive care unit and total hospital length of stay. Lastly, we summarize many studies demonstrating the robust effect of IV acetaminophen on patient satisfaction. A holistic view of total hospital performance should be adopted when reviewing drugs rather than a silo mentality within the pharmacy. While IV acetaminophen adds to drug costs, the body of evidence indicates this drug has the potential to improve outcomes and hospital efficiency.

Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting

Objective:Assess comparative efficacy of liposome bupivacaine administered at doses ≤266 mg and bupivacaine HCl administered at doses ≤200 mg for postsurgical analgesia.Research design and methods:Analysis of pooled efficacy and safety data from nine double-blind, placebo or active (bupivacaine HCl) controlled multimodal analgesia studies using a single dose of liposome bupivacaine or comparator, given via administration into the surgical site before end of surgery (i.e., inguinal hernia repair, total knee arthroplasty, hemorrhoidectomy, breast augmentation, or bunionectomy). Data from study arms that received liposome bupivacaine doses ≤266 mg were included.Clinical trial registration:Pooled data analysis includes nine studies: Study 1 – NCT01203644; Study 2 – NCT00485433; Study 3 – NCT00485693; Study 4 – NCT00529126; Study 5 – NCT00745290; Study 6 – NCT00744848; Study 7 – NCT00813111; Study 8 – NCT00890721; Study 9 – NCT00890682.Main outcome measures:Outcome measures included area under the curve (AUC) of pain intensity scores assessed by numeric rating scale (NRS) through 72 h postsurgery, time to first use of rescue opioid medications, total amount (mg) of opioid medications used, and occurrence of opioid-related adverse events (ORAEs). Incidence of overall AEs was also assessed.Results:Mean cumulative pain score (AUC of NRS through 72 h) was significantly lower with liposome bupivacaine (283) compared with bupivacaine HCl (329, p = 0.039). Median time from administration of study drug to first use of opioid rescue medication was significantly longer for liposome bupivacaine (10 h vs 3 h, p < 0.0001). Liposome bupivacaine was associated with a significant reduction in opioid use (12 mg vs 19 mg; p < 0.0001) and incidence of ORAEs (20% vs 36%; p < 0.0001), compared with bupivacaine HCl.Conclusions:In this pooled analysis from nine studies representing five different surgical procedures, liposome bupivacaine administered at doses ≤266 mg in a multimodal setting was associated with statistically significant and clinically meaningful lower cumulative pain score at 72 h, delayed and less consumption of opioids, and fewer ORAEs than bupivacaine HCl.

A Double-Blind, Randomized, Active-Controlled Study for Post-Hemorrhoidectomy Pain Management with Liposome Bupivacaine, a Novel Local Analgesic Formulation

This randomized, active-controlled study evaluated the extent and duration of analgesia after administration of liposome bupivacaine (LB), a novel formulation of bupivacaine, compared with bupivacaine HCl given via local infiltration in excisional hemorrhoidectomy. One hundred patients were randomly assigned to receive a single dose of bupivacaine HCl 75 mg (0.25% with 1:200,000 epinephrine) or LB 66, 199, or 266 mg upon completion of hemorrhoidectomy. Postoperative pain intensity was assessed using a numeric rating scale at rest to calculate a cumulative pain score (area under the curve). Cumulative pain scores were significantly lower with LB at each study dose (P < 0.05) compared with bupivacaine HCl 72 hours after surgery. Post hoc analysis showed that mean total postoperative opioid consumption was statistically significantly lower for the LB 266-mg group compared with the bupivacaine HCl group during the 12- to 72-hour postoperative period (P = 0.019). Median time to first opioid use was 19 hours for LB 266 mg versus 8 hours for bupivacaine HCl (P = 0.005). Incidence of opioid-related adverse events was 4 per cent for LB 266 mg compared with 35 per cent for bupivacaine HCl (P = 0.007). Local infiltration with LB resulted in significantly reduced postsurgical pain compared with bupivacaine HCl in patients after hemorrhoidectomy surgery.

Is There a Learning Curve Associated with the Use of Remifentanil?

This study prospectively determined whether there was a learning curve with the use of remifentanil, as indicated by decreased hemodynamic variability, improved recovery profile, and decreased incidence of opioid-related adverse events with increasing experience. Patients undergoing diverse surgical

Is there a learning curve associated with the use of remifentanil?

This study prospectively determined whether there was a learning curve with the use of remifentanil, as indicated by decreased hemodynamic variability, improved recovery profile, and decreased incidence of opioid-related adverse events with increasing experience. Patients undergoing diverse surgical procedures (outpatient [n = 1340] and inpatient [n = 560]) were enrolled by investigators (n = 190) who had no previous experience with remifentanil use. Each investigator enrolled 10 patients. A standardized protocol for administration of remifentanil was used. Data were analyzed to determine differences between the first three patients and the last three patients enrolled for each anesthesiologist in the study. There were no differences in hemodynamic variables between the first triad and the last triad in either outpatients or inpatients. Requirements for hypnotic drugs and the doses of remifentanil used were also similar between groups. Analgesic medications administered at the end of surgery and in the postanesthesia care unit (PACU) were similar between groups, except that the last triad in the outpatient group received smaller doses of fentanyl compared with the first triad. Times to response to verbal command, tracheal extubation, and operating room discharge did not differ between groups. However, patients in the last triad undergoing outpatient surgery had shorter times to eligibility for PACU discharge, but times to eligibility for discharge home did not differ. The overall incidence of all adverse events (i.e., hypotension, hypertension, muscle rigidity, respiratory depression, apnea, nausea, and vomiting) was less in the last triad as compared with the first triad. When analyzed separately, only the incidence of vomiting (in the outpatient group) was decreased in the last triad as compared with the first triad. This study suggests that there is a learning curve that aids reduction of minor adverse effects associated with the use of analgesic medications administered at the end of surgery in outpatients, which might have reduced the incidence of postoperative vomiting and the duration of PACU stay. This study demonstrated that anesthesiologists rapidly acquire the ability to use remifentanil with limited experience. However, there is a learning curve that aids reduction of minor adverse effects associated with the use of analgesic medications administered at the end of surgery in outpatients, which might have reduced the incidence of postoperative vomiting and the duration of postanesthesia care unit stay.