Effectiveness of Liposomal Bupivacaine With Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Local Anesthetic for Children Undergoing Ambulatory Urologic Surgery: The Baby ORIOLES Randomized Clinical Trial.

PURPOSE: We sought to determine if the addition of liposomal bupivacaine to bupivacaine hydrochloride improves opioid-free rate and postoperative pain scores among children undergoing ambulatory urologic surgery. MATERIALS AND METHODS: A prospective, phase 3, single-blinded, single-center randomized trial with superiority design was conducted in children 6 to 18 years undergoing ambulatory urologic procedures between October 2021 and April 2023. Patients were randomized 1:1 to receive dorsal penile nerve block (penile procedures) or incisional infiltration with spermatic cord block (inguinal/scrotal procedures) with weight-based liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome was opioid-free rate at 48 hours. Secondary outcomes included parents' postoperative pain measure scores, numerical pain scale scores, and weight-based opioid utilization at 48 hours and 10 to 14 days. RESULTS: We randomized 104 participants, with > 98% (102/104) with complete follow-up data at 48 hours and 10 to 14 days. At interim analysis, there was no significant difference in opioid-free rate at 48 hours between arms (60% in the intervention vs 62% in the control group; estimated difference in proportion -1.9% [95% CI, -20%-16%]; P = .8). We observed no increased odds of patients being opioid-free at 48 hours with the intervention compared to the control group (OR 0.96 [95% CI 0.41-2.3]; P = .9). The trial met the predetermined futility threshold for early stopping. There was no difference in parents' postoperative pain measure scores, numerical pain scale scores, or opioid utilization at 48 hours or 10 to 14 days. No difference in adverse events was observed. CONCLUSIONS: The addition of liposomal bupivacaine to bupivacaine hydrochloride did not significantly improve opioid-sparing effect or postoperative pain compared with bupivacaine hydrochloride alone among children ≥ 6 years undergoing ambulatory urologic surgery.

Analgesic Effectiveness of Liposomal Bupivacaine versus Plain Local Anesthetics for Abdominal Fascial Plane Blocks: A Systematic Review and Meta-analysis of Randomized Trials.

BACKGROUND: Liposomal bupivacaine is reported to prolong the duration of analgesia when used for abdominal fascial plane blocks compared to plain local anesthetics; however, evidence from randomized trials is mixed. This meta-analysis aims to compare the analgesic effectiveness of liposomal bupivacaine to plain local anesthetics in adults receiving abdominal fascial plane blocks. METHODS: Randomized trials comparing liposomal bupivacaine and plain (nonliposomal) local anesthetics in abdominal fascial plane blocks were sought. The primary outcome was area under the curve rest pain between 24 to 72 h postoperatively. Secondary outcomes included rest pain at individual timepoints (1, 6, 12, 24, 48, and 72 h); analgesic consumption at 0 to 24, 25 to 48, and 49 to 72 h; time to analgesic request; hospital stay duration; and opioid-related side effects. Data were pooled using the Hartung-Knapp-Sidik-Jonkman random effects method. RESULTS: Sixteen trials encompassing 1,287 patients (liposomal bupivacaine, 667; plain local anesthetics, 620) were included. The liposomal bupivacaine group received liposomal bupivacaine mixed with plain bupivacaine in 10 studies, liposomal bupivacaine alone in 5 studies, and both preparations in 1 three-armed study. No difference was observed between the two groups for area under the curve pain scores, with a standardized mean difference (95% CI) of -0.21 cm.h (-0.43 to 0.01; P = 0.058; I2 = 48%). Results were robust to subgroup analysis based on (1) potential conflict of interest and (2) mixing of plain local anesthetics with liposomal bupivacaine. The two groups were not different for any of the day 2 or day 3 secondary outcomes. CONCLUSIONS: This systematic review and meta-analysis suggests similar analgesic effectiveness between liposomal bupivacaine and plain local anesthetics when used for fascial plane block of the abdominal wall. The authors' analysis does not support an evidence-based preference for liposomal bupivacaine compared to plain local anesthetics for abdominal fascial plane blocks.

Liposomal Bupivacaine for Peripheral Nerve Blockade: A Randomized, Controlled, Crossover, Triple-blinded Pharmacodynamic Study in Volunteers.

BACKGROUND: Little is known about the pharmacodynamic characteristics of liposomal bupivacaine. Hypothesizing that they would not identify pharmacodynamic differences from plain bupivacaine during the initial period after administration, but would find better long-term pharmacodynamic characteristics, the authors designed a randomized, controlled, triple-blinded, single-center study in volunteers. METHODS: Volunteers aged 18 to 55 yr (body mass index, 18 to 35 kg/m2) received two ulnar nerve blocks under ultrasound guidance. Using a crossover design with a washout phase of 36 days or more, one block was performed with liposomal and one with plain bupivacaine. Which came first was determined by randomization. Sensory data were collected by pinprick testing and motor data by thumb adduction, either way in comparison with the contralateral arm. Endpoints included success, time to onset, and duration of blockade. Residual efficacy was assessed by the volunteers keeping a diary. Statistical analysis included Wilcoxon signed-rank and exact McNemar's tests, as well as a generalized estimation equation model. RESULTS: Successful sensory blockade was noted in 8 of 25 volunteers (32%) after liposomal and in 25 of 25 (100%) after plain bupivacaine (P < 0.0001). Significant differences emerged for time to onset, defined as 0% response to pinpricking in four of five hypothenar supply areas (P < 0.0001), and for time from onset to 80% or 20% in one of five areas (P < 0.001; P < 0.001). Carryover effects due to the randomized sequencing were unlikely (estimate, -0.6286; sequence effect, 0.8772; P = 0.474). Self-assessment greater than 3.5 days did reveal, for liposomal bupivacaine only, intermittent but unpredictable episodes of residual sensory blockade. CONCLUSIONS: The results show that liposomal bupivacaine is not a suitable "sole" drug for intraoperative regional anesthesia. Findings of its limited long-term efficacy add to existing evidence that a moderate effect, at best, should be expected on postoperative pain therapy.

Addition of Liposomal Bupivacaine to Standard Bupivacaine versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial.

BACKGROUND: The analgesic effect of adding liposomal bupivacaine to standard bupivacaine in supraclavicular brachial plexus block is not known. The authors hypothesized that addition of liposomal bupivacaine would reduce acute postoperative pain compared to standard bupivacaine alone. METHODS: A randomized controlled trial was conducted. Patients and outcome assessors were blinded. Eighty patients undergoing distal radial fracture fixation during regional anesthesia with supraclavicular brachial plexus block were randomized into two groups. The liposomal bupivacaine group received 10 ml 0.5% plain bupivacaine immediately followed by 10 ml 1.33% liposomal bupivacaine (n = 40). The standard bupivacaine group received 20 ml 0.5% plain bupivacaine (n = 40). The primary outcome was weighted area under curve (AUC) numerical rating scale pain score at rest during the first 48 h after surgery. Secondary outcomes included weighted AUC scores for pain with movement, overall benefit with analgesia score, and other functional scores. RESULTS: For the primary outcome, the liposomal bupivacaine group was associated with statistically significantly lower weighted AUC pain score at rest (0.6 vs. 1.4; P < 0.001) in the first 48 h. Of the secondary outcomes, no difference between treatment groups reached statistical significance with the exception of weighted AUC score for pain with movement (2.3 vs. 3.7; adjusted P < 0.001) and overall benefit with analgesia score (1.1 vs. 1.7; adjusted P = 0.020) in the first 48 h, as well as numerical rating scale pain score at rest (0.5 vs. 1.9; adjusted P < 0.001) and with movement (2.7 vs. 4.9; adjusted P < 0.001) on postoperative day 1. Differences in numerical rating scale pain scores on postoperative days 2, 3, and 4 did not reach the level of statistical significance. There were no statistically significant differences in sensory function. CONCLUSIONS: Liposomal bupivacaine given via supraclavicular brachial plexus block reduced pain at rest in the early postoperative period.

Development of an Accelerated Rotator-based Drug Release Method for the Evaluation of Bupivacaine Multivesicular Liposomes.

PURPOSE: A multivesicular liposome (MVL) is a liposomal vehicle designed to achieve sustained release characteristics for drugs with short half-lives. For example, a commercial MVL formulation of bupivacaine has been approved by the U.S. Food and Drug Administration for local and regional analgesia. For complex formulations like those containing MVLs, challenges in developing an in vitro release testing (IVRT) method may hinder generic development and regulatory approval. In this study, we developed an accelerated rotator-based IVRT method with the ability to discriminate bupivacaine MVLs with different quality attributes. METHODS: Three IVRT experimental setups including mesh tube, horizontal shaker, and vertical rotator were screened to ensure that at least 50% of bupivacaine can release from MVLs in 24 h. Sample dilution factors, incubation temperature, and the release media pH were optimized for the IVRT. The reproducibility of the developed IVRT method was validated with commercial bupivacaine MVLs. The discriminative capacity was assessed via comparing commercial and compromised bupivacaine MVL formulations. RESULTS: The rotator-based release setup was chosen due to the capability to obtain 70% of drug release within 24 h. The optimized testing conditions were chosen with a 50-fold dilution factor, a temperature of 37ºC, and a media pH of 7.4. CONCLUSIONS: An accelerated rotator-based IVRT method for bupivacaine MVLs was developed in this study, with the discriminatory ability to distinguish between formulations of different qualities. The developed IVRT method was a robust tool for generic development of MVL based formulations.

The use of granisetron on bupivacaine induced sciatic nerve block in rats.

PURPOSE: The effects of the 5-hydroxytryptamine (5-HT3) receptor antagonists on regional anaesthesia are complex and unclear. The present study was designed to test the hypothesis that granisetron, a selective 5-HT3 receptor antagonist, would decrease the duration of motor block, sensory block, and proprioception in a dose-dependent fashion in a rat model of bupivacaine-induced sciatic nerve blockade. MATERIALS AND METHODS: Thirty-eight male Wistar Albino rats that received unilateral sciatic nerve blocks were randomly divided into five experimental groups. Group B received a perineural of 0.3 ml of bupivacaine alone; Group BG800 received perineural 0.3 ml of bupivacaine and 800 µg of granisetron 10 min later; Group BG1200 received perineural 0.3 ml of bupivacaine and 1200 µg of granisetron 10 min later; Group BG1200IP received a perineural 0.3 ml of bupivacaine and an intraperitoneal injection of 1200 µg of granisetron 10 min later; and Group S was sham operated. A blinded investigator assessed motor, sensory and proprioception function every 10 min until the return of normal function. RESULTS: The medians for recovery times in Group B, Group BG800, Group BG1200, and Group BG1200IP were 105, 64, 85, and 120 min for motor function, respectively; 80, 64, 84, and 104 min for sensory function; 80, 63, 85, and 108 min were calculated for the proprioception function. The time to the return of normal motor, sensory, and proprioception function was not statistically significantly different between the groups (p > 0.05). Motor block did not develop in any of the rats in Group S. CONCLUSIONS: Local and systemic application of granisetron was not significantly decrease the duration of bupivacaine induced motor, sensory, and proprioception block of sciatic nerve in rat.

Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labour?

BACKGROUND AND AIM: Intrathecal fentanyl, using the combined spinal-epidural (CSE) technique, provides rapid analgesia during early labour. Because of the technique's more complex and invasive nature, as its replacement we assessed the use of epidural analgesia in primiparous parturients with induced labour. The study was registered at www. CLINICALTRIALS: gov (NCT04645823). The aim was to compare the efficacy, duration of analgesia and maternal satisfaction. The primary outcome was the difference in pain visual analogue scale (VAS) between the interventions at 20 min after the analgesia administration. METHODS: Sixty volunteering parturients were randomly allocated in 1:1 ratio to receive either intrathecal fentanyl 20 µg or epidural analgesia (fentanyl 100 µg and lidocaine 80 mg). Contraction pain and maternal satisfaction were assessed by 0-100 mm VAS for 30 min, respectively. Foetal heart rate abnormalities, the time to first epidural dose and the incidence of pruritus were recorded. Non-inferiority margin for mean (95% CI) VAS after epidural analgesia was set at 20 mm above the VAS value for intrathecal fentanyl at 20 min. RESULTS: The contraction pain VAS fell from (median [interquartile range, IQR]) 82 (14) to 13 (20) mm and 76 (17) to 12 (27) mm in 20 min following the intrathecal fentanyl and epidural analgesia, respectively. The absolute mean difference (epidural-intrathecal fentanyl) in the VAS values was 3.3(-0.06 to 6.66) mm indicating non-inferiority. The median time to reach VAS <30 mm was 10 min in both groups. The duration until request for supplemental analgesia was 82(69-95) and 91(75-106) min after intrathecal fentanyl and epidural analgesia, respectively. The difference for the duration (epidural-intrathecal fentanyl) was 9 (6-12) min and for satisfaction-VAS 0.3 (-3.0 to 3.7) mm. There were no differences between the groups in the incidence of foetal heart rate abnormalities, while pruritus was more common after intrathecal fentanyl. CONCLUSION: After 20 min, epidural analgesia by lidocaine and fentanyl was within the non-inferior threshold compared with intrathecal fentanyl in efficacy. The duration of action was not shorter than that of intrathecal fentanyl and maternal satisfaction was also similar.

Erector Spinae versus Surgically Placed Pain Catheters for Thoracic Outlet Decompression.

BACKGROUND: Perioperative care after surgery for thoracic outlet syndrome (TOS) involves multimodal pain control. Pain catheters with bupivacaine infusion are a modality to minimize perioperative narcotic use. Our study aims to compare surgically placed pain catheters (SP) with erector spinae pain catheters (ESP) placed by the anesthesia pain service. METHODS: Retrospective review of a prospectively maintained surgical TOS database identified patients undergoing transaxillary first rib resection (FRR) who had either SP or ESP placed for pain control. Patients were matched for age and gender. Data collected included demographics, operative details, and perioperative pain medication use. Narcotic pain medication doses were converted to milligram morphine equivalents (MMEs) for comparison between groups. Pain medications were collected for several time points: intraoperatively, for each postoperative day (POD) and for the entire hospital stay. RESULTS: Eighty-eight total patients were selected for comparison: 44 patients in the SP and ESP groups. Patients in each group did not differ with regards to age, body mass index, gender, diagnosis, or comorbidities. There were no differences in preoperative narcotic use, preoperative pain score, or Quick Disabilities of Arm, Shoulder, and Hand score. All patients underwent FRR. Concurrent cervical rib resection was performed in 6.8% SP and 6.8% ESP patients (P = 1.00), pectoralis minor tenotomy in 34.1% SP and 29.5% ESP patients (P = 0.65), and venogram in 31.8% SP and 31.8% ESP patients (P = 1.00). Mean operating room time was 90.0 min in SP and 105.3 min in ESP cases (P = 0.15). Mean length of stay was 1.9 days for SP and 1.8 days for ESP patients (P = 0.56). There were no significant differences in intraoperative narcotics dosing in MME (SP: 22.1 versus ESP: 25.3, P = 0.018). On POD 0, there were no differences in total narcotics dosing (MME) (SP: 112.0 versus ESP: 100.7, P = 0.59), or in the use of acetaminophen, nonsteroidal anti-inflammatory drugs, or muscle relaxants. A similar trend in narcotics dosing was observed on POD 1 (SP: 58.6 versus ESP: 69.7, P = 0.43) and POD 2 (SP: 23.5 versus ESP: 71.3, P = 0.23). On POD 1, there was a higher percentage of SP patients taking nonsteroidal anti-inflammatory drugs (63.6% vs. 40.9%, P = 0.024); however, this difference was not observed on POD 2. There were no differences in acetaminophen or muscle relaxant use on POD 1 or 2. Total hospital stay MME was similar between groups (SP: 215.9 versus ESP: 250.9, P = 0.23). CONCLUSIONS: Pain catheters with bupivacaine infusions are helpful adjuncts in postoperative pain control after FRR for TOS. This study compares SP to ESP and demonstrates no difference in narcotics use between SP and ESP groups. SP should be used for pain control in facilities which do not have an anesthesia pain service available for ESP placement.

The analgesic effect of transversalis fascia plane block after caesarean section under spinal anaesthesia with intrathecal morphine: a randomised controlled trial.

We aimed to test whether bilateral injection of bupivacaine 0.25% in the transversalis fascia plane reduced 24 h opioid dose after singleton caesarean section, under spinal anaesthesia with intrathecal morphine, compared with saline 0.9% injectate. We allocated randomly 52 women to bilateral injection of 20 ml saline 0.9% on arrival in the post-anaesthesia care unit and 54 women to bilateral injection of 20 ml bupivacaine 0.25% (with adrenaline 2.5 µg.ml-1 ). Mean (SD) cumulative morphine equivalent opioid dose 24 h after saline injection was 32.3 (28.3) mg and 18.7 (20.2) mg after bupivacaine injection, a mean (95%CI) difference of 13.7 (4.1-23.2) mg (p = 0.006). Median (IQR [range]) time to first postoperative opioid dose was 3.0 (1.5-10.3 [0.0-57.4]) h after saline 0.9% and 8.2 (2.7-29.6 [0.2-55.4]) h after bupivacaine 0.25% (p = 0.054). Transversalis fascia plane with bupivacaine 0.25% with adrenaline reduced postoperative pain at rest during 48 h (0-10-point scale) by a mean (95%CI) of 0.9 (0.2-1.6) points (p = 0.013) and on movement by 1.2 (0.4-2.1) points (p = 0.004). We conclude that transversalis fascia plane bupivacaine 0.25% with adrenaline reduces pain and opioid dose after caesarean section compared with saline 0.9%.

Ultrasound-guided pericapsular nerve block compared with IV opioids in hip injuries: A randomised controlled trial.

STUDY OBJECTIVES: The study aimed to compare the analgesic effect of USG-guided PENG (Peri capsular nerve group) block with Intravenous Nalbuphine hydrochloride (IVN) in patients with hip fracture coming to the emergency department (ED). The purpose was also to monitor the adverse effects and rescue analgesic requirements in both treatment modalities. METHODS: The study was an open-label randomised controlled trial (RCT) comparing PENG block versus IVN in treating patients with femoral head and neck fractures, as well as pubic rami fracture of the hip (HF). The participants in the PENG group received a USG-guided PENG block by injection of 25 ml of 0.25% bupivacaine, whereas the IVN group received 0.15 mg/kg of nalbuphine. An emergency physician with expertise in ultrasound-guided nerve blocks performed the PENG blocks. The primary outcome was to measure the improvement of the NRS (Numerical rating scale) score at 30 min in both static position (Patient-chosen position for the best comfort) and dynamic position (15-degree passive affected lower limb elevation). Secondary outcomes were to measure static and dynamic NRS pain scores at 2 h, 4 h, and 6 h after intervention in both groups. The requirement for rescue analgesia, adverse events and any block-related complications were also recorded. RESULTS: A total of 60 patients with HF were included in the final analysis. The static and dynamic NRS score was significantly lower in the PENG group compared to the IVN group at 30 min, 2 h, 4 h, and 6 h post-intervention. In the PENG group, the static NRS score was improved by 5.73 ± 1.17, while In the IVN group, the static NRS score was just improved by 2.13 ± 0.97 at 30 min. In the same duration, the Dynamic NRS score in the PENG group was improved by 6.13 ± 1.38, while In the IVN group, it improved just by 2.43 ± 1.28. Rescue analgesia was required in 50.0% of patients in the IVN group but none in the PENG group. Further, no block-related complications or adverse events were observed in the patients of the PENG group. CONCLUSION: The study provides evidence that the ultrasound-guided PENG block has a better analgesic effect and has fewer adverse events than IV opioids in patients with HF.

Ultrasound-guided erector spinae nerve block for relief of endometriosis pain in the emergency department.

Endometriosis is a debilitating chronic condition often accompanied by severe pelvic pain and infertility issues. When outpatient medical management is not adequate, controlling pain can be challenging for providers in the acute setting. We report the case of a 23-year-old female with a past medical history of endometriosis who presented to a freestanding emergency department with a chief complaint of 10/10 pelvic pain on a numeric rating scale. She had tried non-steroidal inflammatory medications and heat with no success. The patient had medication intolerances to opioid analgesics and was given ketorolac intramuscularly with no relief of her pain. The emergency physician discussed and offered to perform an erector spinae plane nerve block (ESPB) for pain relief. Ultrasonography was utilized for visualization of landmarks with a curvilinear transducer; a 20-gauge Pajunk® Sonoplex needle was used to inject a total of 100 mg bupivacaine 0.25% without epinephrine along with dexamethasone 10 mg under the bilateral erector spinae fascial planes at the T9 level. Post-procedure, the patient had significant improvement in pain and rated it a 2/10. Utilizing nerve blocks for endometriosis and other chronic pelvic pain in the acute care setting can serve as an effective alternative to opioids. In patients with multiple medication intolerances and for providers navigating pain control in the setting of a nationwide opioid crisis, ESPB blocks can help alleviate acute pain or exacerbations of chronic pain. This case demonstrates the first known use of an ESPB to relieve endometriosis pain in the emergency department.

Liposomal and Nonliposomal Bupivacaine for Mohs Surgery: A Systematic Review.

BACKGROUND: Lidocaine is the most commonly used local anesthetic for Mohs micrographic surgery (MMS), but given its limited half-life, postoperative pain remains a significant concern for patients. Bupivacaine is used in various surgical subspecialty procedures and has demonstrated improved pain control compared with lidocaine. However, its role in MMS is insufficiently explored. OBJECTIVE: To systematically review the current literature for reports on use of bupivacaine, traditional nonliposomal and newer liposomal formulations, for MMS. METHODS: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. The MEDLINE, PubMed, and EMBASE databases were queried for articles presenting original data on the use of bupivacaine for MMS. RESULTS: Of 483 potentially relevant articles, 3 studies met final inclusion criteria, capturing a total of 253 patients involved in primary investigations comparing bupivacaine to traditional local anesthesia for MMS. Bupivacaine was well-tolerated and associated with comparable or modestly reduced intraoperative and postoperative pain and opioid use. CONCLUSION: Bupivacaine may have a role in prolonging intraoperative anesthesia, reducing acute postoperative pain, and reducing postoperative opioid use after MMS. However, large, prospective studies are needed to solidify the generalizability and clinical utility of these findings.

Intrathecal Anesthesia Prevents Ventricular Arrhythmias in Rats with Myocardial Ischemia/Reperfusion.

INTRODUCTION: Ventricular arrhythmia is commonly provoked by acute cardiac ischemia through sympathetic exaggeration and is often resistant to anti-arrhythmic therapies. Thoracic epidural anesthesia has been reported to terminate fatal ventricular arrhythmia; however, its underlying mechanism is unknown. METHODS: Rats were randomly divided into four groups: sham, sham plus bupivacaine, ischemia/reperfusion (IR), and IR plus bupivacaine groups. Bupivacaine (1 mg/mL, 0.05 mL/100 g body weight) was injected intrathecally into the L5-L6 intervertebral space prior to establishing a myocardial IR rat model. Thereafter, cardiac arrhythmia, cardiac function, myocardial injury, and electrical activities of the heart and spinal cord were evaluated. RESULTS: Intrathecal bupivacaine inhibited spinal neural activity, improved heart rate variability, reduced ventricular arrhythmia score, and ameliorated cardiac dysfunction in IR rats. Furthermore, intrathecal bupivacaine attenuated cardiac injury and myocardial apoptosis and regulated cardiomyocyte autophagy and connexin-43 distribution during myocardial IR. CONCLUSION: Our results indicate that intrathecal bupivacaine blunts spinal neural activity to prevent cardiac arrhythmia and dysfunction induced by IR and that this anti-arrhythmic activity may be associated with regulation of autonomic balance, myocardial apoptosis and autophagy, and cardiac gap junction function.

Effect of Preoperative Bilateral Ultrasound-Guided Quadratus Lumborum Nerve Block on Quality of Recovery After Minimally Invasive Hysterectomy in an Enhanced Recovery After Surgery (ERAS) Setting.

STUDY OBJECTIVE: To assess the effect of preoperative bilateral ultrasound-guided quadratus lumborum nerve block (QLB) on quality of recovery after minimally invasive hysterectomy, in an enhanced recovery after surgery setting. DESIGN: Randomized, controlled, double-blinded trial (Canadian Task Force level I). SETTING: University-affiliated tertiary medical center. PATIENTS: All women undergoing an elective robotic or laparoscopic hysterectomy. Women with chronic pain, chronic anticoagulation, and body mass index >50 kg/m2 were excluded. INTERVENTION: Patients were randomized with a 1:1 allocation, to one of the following 2 arms, and stratified based on robotic versus laparoscopic approach. 1. QLB: QLB (bupivacaine) + sham local trocar sites infiltration (normal saline) 2. Local infiltration: sham QLB (normal saline) + local infiltration (bupivacaine) MEASUREMENTS AND MAIN RESULTS: The primary outcome was defined as the quality of recovery score based on the validated questionnaire Quality of Recovery, completed 24 hours postoperatively. Secondary outcomes included dynamic pain scores, accumulated opioid consumption up to 24 hours, postoperative nausea and vomiting, surgical complications, length of hospital stay, time to first pain medication administration in the postanesthesia care unit, and adverse events. A total of 76 women were included in the study. Demographic characteristics were similar in both groups. Median age was 44 years (interquartile range 39-50), 47% of the participants were African American, and mean body mass index was 32.8 kg/m2 (standard deviation [SD] 8.1). The mean Quality of Recovery score was 179.1 (SD ± 10.3) in the QLB and 175.6 (SD ± 9.7) for the local anesthesia group (p = .072). All secondary outcomes were comparable between groups. CONCLUSIONS: QLBs do not significantly improve quality of recovery after elective robotic or laparoscopic hysterectomy compared with local anesthetic port site infiltration.

Incidence and factors associated with failed spinal anaesthesia among patients undergoing surgery: a multi- center prospective observational study.

BACKGROUND: Failed spinal anaesthesia causes prolonging of operation time, insufficient analgesia for surgery and needs repeating spinal anaesthesia which in turn causes local anaesthesia toxicity, high spinal and total spinal, and conversion to general anaesthesia. However, the problem remains unexplored in Amhara regional state comprehensive specialized hospitals. OBJECTIVE: To determine incidence and factors associated with failed spinal anaesthesia among patients undergoing surgery in selected Amhara National Regional State comprehensive specialized hospitals, Northwest Ethiopia, 2023. METHODS: Multi-center prospective observational study was conducted. Data was collected using questionnaire and checklist. All consecutive scheduled emergency and elective patients were included in the study. Data was transformed from Epi data to SPSS and logistic regression analysis was done. Both crude and adjusted odds ratio were used to assess the strength of association. Variables with a p-value of less than 0.05 were considered as statistically significant. RESULTS: A total of 532 patients were included in this study with a response rate of 98%. Incidence of failed spinal anaesthesia was 22.4% (CI = 19-25.9). Emergency surgery (AOR = 7.01, CI = 4.5-12.7), dose of bupivacaine of ≤ 10 mg (AOR = 3.02, CI = 1.3-10.2), work experience of anaesthetist < 2 years (AOR = 3.1, CI = 1.7-5.72), bloody CSF (AOR = 8.5, CI = 2.53-18.5), hyperbaric local anaesthetic drug (AOR = 3.3, 95% CI = 3.2-8.2) and local anaesthetist without adjuvants (AOR = 5.25, CI = 2.62-14.2) were associated failed spinal anaesthesia. CONCLUSION AND RECOMMENDATION: The incidence of failed spinal anaesthesia was high in Amhara Region comprehensive specialized hospitals. We suggest that anaesthesia providers should minimize failure by using adjuvants and appropriate dose of local anaesthetic. Additionally, simulation training should be given for anaesthesia trainees to improve their skills and to produce competent professionals.

Use of intermediate cervical plexus block in carotid endarterectomy -an alternative to deep cervical plexus block: a case series.

INTRODUCTION: Carotid endarterectomy is performed for patients with symptomatic carotid artery occlusions. Surgery can be performed under general and regional anesthesia. Traditionally, surgery is performed under deep cervical plexus block which is technically difficult to perform and can cause serious complications. This case series describes 5 cases in which an intermediate cervical plexus block was used in combination with a superficial cervical plexus block for Carotid endarterectomy surgery. METHODS: Five patients who were classified as American Society of Anesthesiologists 2-3 were scheduled for Carotid endarterectomy due to symptoms and more than 70% occlusion of the carotid arteries. The procedures were carried out in the University Teaching Hospital- Peradeniya, Sri Lanka. All patients were given superficial cervical plexus block followed by intermediate cervical plexus block using 2% lignocaine and 0.5% plain bupivacaine. RESULTS: Adequate anesthesia was achieved in 4 patients, and local infiltration was necessary in 1 patient. Two patients developed hoarseness of the voice, which settled 2 h after surgery. Hemodynamic fluctuations were observed in all 5 patients. No serious complications were observed. All 5 patients had uneventful recoveries. DISCUSSIONS: Regional anesthesia for CEA is preferable in patients who are medically complicated to undergo anesthesia or in patients for whom cerebral monitoring is not available. Intermediate cervical plexus block is described for thyroid surgeries in literature, but not much details on its use for carotid surgeries. Deep cervical plexus blocks has few serious complications which is not there with the use of ICPB making it a good alternative for CEA surgeries . CONCLUSIONS: Superficial cervical plexus block and intermediate cervical plexus block can be used effectively for providing anesthesia for patients undergoing Carotid endarterectomy. It is safe and easier to conduct than deep cervical plexus block and enables monitoring of cerebral function.

The impact of epidural ropivacaine versus levobupivacaine for labor analgesia on maternal and fetal outcomes: a meta-analysis.

INTRODUCTION: Newer neuraxial local anesthetic agents which have been used as epidural analgesia have shown to provide reliable pain relief during labor. Ropivacaine and levobupivacaine are newer agents now used for labor analgesia. However, even though few studies have made their comparison with bupivacaine, ropivacaine and levobupivacaine have seldom systematically been compared. Therefore, in this analysis, we aimed to systematically show the impact of epidural ropivacaine versus levobupivacaine for labor analgesia on maternal and fetal outcomes. METHODS: http://www. CLINICALTRIALS: gov , Web of Science, MEDLINE, EMBASE, Cochrane database and Google Scholar were searched for studies comparing ropivacaine versus levobupivacaine for labor analgesia. Maternal and fetal outcomes were considered as the endpoints in this analysis. The RevMan software 5.4 was used to analyze data in this study. Risk ratio (RR) with 95% confidence intervals (CI) were used to represent the data post analysis. RESULTS: A total number of 2062 participants were included in this analysis whereby 1054 participants were assigned to ropivacaine and 1008 participants were assigned to levobupivacaine. The main results of this analysis showed that epidural ropivacaine was not associated with significantly higher risk of hypotension (RR: 0.71, 95% CI: 0.43 - 1.17; P = 0.18) and pruritus (RR: 1.12, 95% CI: 0.89 - 1.42; P = 0.34) when compared to levobupivacaine for labor analgesia. However, the risk of nausea and vomiting was significantly higher with ropivacaine (RR: 1.60, 95% CI: 1.05 - 2.44; P = 0.03). Spontaneous vaginal delivery (RR: 0.99, 95% CI: 0.89 - 1.42; P = 0.83), instrumental vaginal delivery (RR: 1.13, 95% CI: 0.89 - 1.45; P = 0.32) and the risk for cesarean section (RR: 0.76, 95% CI: 0.42 - 1.37; P = 0.35) were not significantly different. When fetal outcomes were assessed, Apgar score < 7 at 1 min (RR: 1.01: 95% CI: 0.57 - 1.80; P = 0.97), abnormality of fetal heart rate (RR: 1.45, 95% CI: 0.55 - 3.79; P = 0.45) and neonatal asphyxia (RR: 0.35, 95% CI: 0.10 - 1.18; P = 0.09) were also similarly manifested. CONCLUSIONS: To conclude, our analysis showed both epidural ropivacaine and levobupivacaine to be equally effective for labor analgesia in terms of maternal and fetal outcomes. No major adverse maternal and fetal outcome was observed in this analysis. However, considering the several limitations of this analysis, further larger studies should be able to solve and clarify this issue.

The 90% effective dose of intrathecal hyperbaric bupivacaine for Cesarean delivery under combined spinal-epidural anesthesia in parturients with super obesity: an up-down sequential allocation study.

PURPOSE: To determine the 90% effective dose (ED90) of intrathecal hyperbaric bupivacaine for Cesarean delivery under combined spinal-epidural anesthesia (CSE) in parturients with super obesity (body mass index [BMI] ≥ 50 kg·m-2). METHODS: We enrolled parturients with BMI ≥ 50 kg·m-2 with term, singleton vertex pregnancies undergoing elective Cesarean delivery under CSE. An independent statistician generated the 0.75% hyperbaric bupivacaine dosing regimen in increments of 0.75 mg using a biased-coin up-down sequential allocation technique. This was combined with 15 µg fentanyl, 150 µg morphine, and normal saline to a volume of 2.05 mL. The initial and maximum doses were 9.75 mg and 12 mg, respectively. Participants, clinical team, and outcome assessors were blinded to the dose. The primary outcome was block success, defined as T6 block to pinprick within ten minutes and no intraoperative analgesic supplementation within 90 min of spinal injection. We determined the ED90 using logistic regression. RESULTS: We enrolled 45 parturients and included 42 in the analysis. All doses achieved a T6 level within ten minutes, and the primary outcome occurred in 0/1 (0%) of the 9.75-mg doses, 2/3 (67%) of the 10.5-mg doses, 21/27 (78%) of the 11.25-mg doses, and 11/11 (100%) of the 12-mg doses. The ED90 of hyperbaric bupivacaine was 11.56 mg (95% confidence interval, 11.16 to 11.99). Four parturients (9.5%) had sensory level higher than T2, but none was symptomatic or required general anesthesia. CONCLUSION: The estimated ED90 of hyperbaric bupivacaine with fentanyl and morphine in parturients with super obesity undergoing Cesarean delivery under CSE was approximately 11.5 mg. STUDY REGISTRATION: ClinicalTrials.gov (NCT03781388); first submitted 18 December 2018.

RéSUMé: OBJECTIF: Notre objectif était de déterminer la dose efficace à 90 % (DE90) de bupivacaïne hyperbare intrathécale pour l'accouchement par césarienne sous péri-rachianesthésie combinée (PRC) chez les personnes parturientes atteintes de super obésité (indice de masse corporelle [IMC] ≥ 50 kg·m−2). MéTHODE: Nous avons recruté des personnes parturientes ayant un IMC ≥ 50 kg·m−2 présentant des grossesses uniques à terme, en présentation céphalique et bénéficiant d'un accouchement par césarienne programmée sous PRC. Un·e statisticien·ne indépendant·e a généré le schéma posologique de bupivacaïne hyperbare à 0,75 % par incréments de 0,75 mg à l'aide d'une technique d'allocation séquentielle en escalier. La bupivacaïne a été combinée à 15 µg de fentanyl, 150 µg de morphine et à une solution physiologique salée jusqu'à un volume de 2,05 mL. Les doses initiale et maximale étaient respectivement de 9,75 mg et 12 mg. Les participant·es, l'équipe clinique et les personnes évaluant les résultats n'avaient pas connaissance de la dose. Le critère d'évaluation principal était la réussite du bloc, définie comme un bloc à T6 à la piqûre dans les dix minutes et aucune supplémentation analgésique peropératoire dans les 90 minutes suivant l'injection rachidienne. Nous avons déterminé la DE90 à l'aide d'une méthode de régression logistique. RéSULTATS: Nous avons recruté 45 personnes parturientes et en avons inclus 42 dans l'analyse. Toutes les doses ont atteint le niveau T6 en dix minutes, et le critère d'évaluation principal a été obtenu pour 0/1 (0 %) des doses de 9,75 mg, 2/3 (67 %) des doses de 10,5 mg, 21/27 (78 %) des doses de 11,25 mg et 11/11 (100 %) des doses de 12 mg. La DE90 de bupivacaïne hyperbare était de 11,56 mg (intervalle de confiance à 95 %, 11,16 à 11,99). Quatre personnes parturientes (9,5 %) ont affiché un niveau sensoriel supérieur à T2, mais aucune n'était symptomatique ni n'a nécessité d'anesthésie générale. CONCLUSION: La DE90 estimée de bupivacaïne hyperbare avec fentanyl et morphine chez les personnes parturientes hyperobèses bénéficiant d'une césarienne sous PRC était d'environ 11,5 mg. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT03781388); soumis pour la première fois le 18 décembre 2018.

Accessing the efficacy and peri-operative adverse effects of three different hyperbaric bupivacaine 0.5% dosages for spinal anesthesia induction in lower limb orthopedic surgeries: a randomized clinical trial.

BACKGROUND: Spinal anesthesia (SA) is a conventional method for proper nerve block in abdominopelvic and lower extremity surgeries. Compared to general anesthesia, SA has reduced perioperative complications significantly. The hyperbaric type of bupivacaine hydrochloride (HB) induces spinal anesthesia more efficiently with a lower incidence of life-threatening adverse reactions like Perioperative hemodynamic changes and respiratory depression. More investigations are needed to define the best dosage that provides adequate anesthesia while reducing adverse effects for each surgical procedure. METHODS: This double-blinded randomized clinical trial compared the consequences of the (12.5mg,15mg,20mg) dosages of HB-bupivacaine in elective lower limb orthopedic surgery. Using block randomization, we allocated 60 participants to three (n = 20) study groups. Utilizing the same protocol of anesthesia induction, outcome variables assumed and measured as the incidence of the adverse effects (Hypotension, Anxiety, Bradycardia, Nausea and Vomiting(N/V), Hypoventilation, and Decreased o2 saturation), and the requirement for intervention to control the unwanted reaction. Addressing that, outcome variables were measured 10 times perioperatively. One-way ANOVA test, the chi2 test, or repeated measures ANOVA test with the Bonferroni adjustment were utilized as appropriate. RESULTS: We found that the incidence of hypotension (P-value:0.02) and the N/V (P-value < 0.001) are associated with the HB-bupivacaine dosage. Contrary, our findings indicate that the incidence of apnea, bradycardia, and hypoventilation did not exhibit a significant dose-dependent pattern between the groups. Repeated measures analysis revealed significant intergroup differences for Herat rate, systolic, diastolic, and mean arterial pressure (group*time Pvalue < 0.001). The observed differences were more prominent 10-30 min after injection of HB-bupivacaine. The regression model claimed that gender (P-value:0.002) and drug dosage (P-value:0.03) significantly predict the incidence of adverse effects. CONCLUSION: Our results, suggest that the administration of the 12.5mg HB-bupivacaine provides adequate anesthesia while minimizing the risk of adverse events for lower limb orthopedic surgeries lasting up to 180 min. TRIAL REGISTRATION: The study was registered at the Clinical Trial Registry Center (IRCT20160202026328N7), Registered on 2022.01.10.

Pain management after thoracotomy with dexamethasone and bupivacaine through a peripleural cather: a randomized controlled trial.

INTRODUCTION: Thoracotomy procedures can result in significant pain and cause nausea/vomiting. Glucocorticoids have anti-emetic and analgesic effects due to their anti-inflammatory and nerve-blocking properties. This study investigates the additive effect of local dexamethasone with bupivacaine as sole analgesic medication through a peripleural catheter after thoracotomy. METHOD: The study was conducted as a randomized control trial on 82 patients. Participants were allocated to receive either 2.5 mg/kg of bupivacaine plus 0.2 mg/kg of dexamethasone or 2.5 mg/kg of bupivacaine plus the same amount of normal saline as placebo through a 6 French peripleural catheter implemented above the parietal pleura and beneath the musculoskeletal structure of the chest wall. The primary outcome was the severity of pain 24 h after the operation in the visual analogue scale (VAS) score. Secondary outcomes were the incidence of nausea/vomiting, opioid consumption for pain control, and incidence of any adverse effects. RESULTS: A total of 50 participants were randomized to each group, and the baseline characteristics were similar between the groups. Median of VAS score (6 (3-8) vs. 8 (6-9), p < 0.001), postoperative opioid consumption (9 (36%) vs. 17 (68%) patients, p=0.024), and median length of hospital stay (4 (3-8) vs. 6 (3-12) days, p < 0.001) were significantly lower in the dexamethasone group. However, postoperative nausea/vomiting (p=0.26 for nausea and p=0.71 for vomiting) and surgical site infection (p = 0.55) were similar between the two groups. CONCLUSION: In thoracotomy patients, administering local dexamethasone + bupivacaine through a peripleural catheter can reduce postoperative pain, analgesic consumption, and length of hospital stay. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20220309054226N1, registration date: 3/21/2022.