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.

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.

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.

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 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.

Super-refractory status epilepticus, rhabdomyolysis, central hyperthermia and cardiomyopathy attributable to spinal anesthesia: a case report and review of literature.

BACKGROUND: There are only six past reports of super-refractory status epilepticus induced by spinal anesthesia. None of those patients have died. Only < 15 mg of bupivacaine was administered to all six of them and to our case. Pathophysiology ensuing such cases remains unclear. CASE PRESENTATION: A 27 year old gravida 2, para 1, mother at 37 weeks of gestation came to the operating theater for an elective cesarean section. She had no significant medical history other than controlled hypothyroidism and one episode of food allergy. Her current pregnancy was uneventful. Her American Society of Anesthesiologists (ASA) grade was 2. She underwent spinal anesthesia and adequate anesthesia was achieved. After 5-7 min she developed a progressive myoclonus. After delivery of a healthy baby, she developed generalized tonic clonic seizures that continued despite the induction of general anesthesia. She had rhabdomyolysis, one brief cardiac arrest and resuscitation, followed by stress cardiomyopathy and central hyperthermia. She died on day four. There were no significant macroscopic or histopathological changes in her brain that explain her super refractory status epilepticus. Heavy bupivacaine samples of the same batch used for this patient were analyzed by two specialized laboratories. National Medicines Quality Assurance Laboratory of Sri Lanka reported that samples failed to confirm United States Pharmacopeia (USP) dextrose specifications and passed other tests. Subsequently, Therapeutic Goods Administration of Australia reported that the drug passed all standard USP quality tests applied to it. Nonetheless, they have detected an unidentified impurity in the medicine. CONCLUSIONS: After reviewing relevant literature, we believe that direct neurotoxicity by bupivacaine is the most probable cause of super-refractory status epilepticus. Super-refractory status epilepticus would have led to her other complications and death. We discuss probable patient factors that would have made her susceptible to neurotoxicity. The impurity in the drug detected by one laboratory also would have contributed to her status epilepticus. We propose several possible mechanisms that would have led to status epilepticus and her death. We discuss the factors that shall guide investigators on future such cases. We suggest ways to minimize similar future incidents. This is an idiosyncratic reaction as well.

Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study.

BACKGROUND: There is an association exists between cardiac surgery, performed through median sternotomy, and a considerable postoperative pain. OBJECTIVES: The aim of the current study is to compare the effects of transversus thoracic muscle plane block (TTMPB) and pecto-intercostal fascial plane block (PIFB) upon postoperative opioid consumption among the patients who underwent open cardiac surgery. METHODS: The present prospective, randomized, comparative study was conducted among 80 patients who underwent elective on-pump cardiac surgery with sternotomy. The subjects were randomly assigned to two groups with each group containing 40 individuals. For the TTMPB group, bilateral ultrasound-guided TTMPB was adopted in which 20 ml of 0.25% bupivacaine was used on each side. In case of PIFB group, bilateral ultrasound-guided PIFB was adopted with the application of 20 ml of 0.25% bupivacaine on each side. The researchers recorded the first time for rescue analgesia, the overall dosage of rescue analgesia administered in the first 24 h after the operation and the postoperative complications. RESULTS: The PIFB group took significantly longer time to raise the first request for rescue analgesia (7.8 ± 1.7 h) than the TTMPB group (6.7 ± 1.4 h). Likewise, the PIFB group subjects had a remarkably lower 'overall morphine usage' in the first 24 h after the operation (4.8 ± 1.0 mg) than TTMPB group (7.8 ± 2.0 mg). CONCLUSION: Bilateral ultrasound-guided PIFB provided a longer time for the first analgesic demand than bilateral ultrasound-guided TTMPB in patients undergoing open cardiac surgery. In addition to this, the PIFB reported less postoperative morphine usage than the TTMPB and increases satisfaction in these patients. TRIAL REGISTRATION: This study was registered at Clinical Trials.gov on 28/11/2022 (registration number: NCT05627869).

Comparing the clinical features of lateral and medial approaches of costoclavicular technique versus traditional lateral sagittal technique as infraclavicular brachial plexus block methods: a randomized controlled trial.

BACKGROUND: It is aimed to compare the block onset times and performance features of costoclavicular techniques (medial and lateral approach) versus lateral sagittal technique. METHODS: Patients were randomized into three groups. For costoclavicular techniques, ultrasound probe was placed parallel to clavicle obtaining nerve cords, axillary artery and axillary vein visual from lateral-to-medial, respectively. The block needle was advanced from lateral (Group CLB) or medial (Group CMB) to perform costoclavicular block. For lateral sagittal technique (Group LSB), ultrasound probe was placed sagittal and perpendicular below the coracoid process to obtain sagittal artery image with the cords around. Total 20 ml of 0.5% bupivacaine and 10 ml of 2% lidocaine were deposited for all groups. Sensory and motor block onset times, block performance properties, complications, and patient/surgeon satisfactions were investigated. RESULTS: Among 56 patients, the primary outcome, sensory block onset time was shorter in Group CLB than Group CMB and Group LSB (10 [5-15], 10 [10-20], and 15 [10-15] minutes, respectively, p < 0.05). Motor block onset was also fastest in Group CLB (15 [10-20] mins for CLB, 20 [15-20] mins for LSB, and 22.5 [15-25] mins for CMB, p = 0.004). Block performance properties did not differ between the groups. The only complication observed was vascular puncture with an incidence of 28% in Group CMB. CONCLUSIONS: Lateral approach costoclavicular technique provides fastest block onset than the other techniques. Considering the success and safety profile, this technique stands as a good alternative in clinical practice. TRIAL REGISTRATION: This study is prospectively registered to clinicaltrials.gov on 20/02/2022 (NCT05260736).

Ultrasound guided quadratus lumborum block versus interlaminar epidural block for analgesia in pediatric abdominal surgery: a randomized controlled trial.

BACKGROUND: Although the efficacy and safety of epidural block (EB) are fairly high, complications such as inadvertent dural puncture may limit its use. Ultrasound-guided quadratus lumborum block (QLB) is a relatively new regional technique that provides perioperative somatic and visceral analgesia for pediatric patients. This trial compared the quality of pain relief in pediatric patients undergoing abdominal surgery who received either QLB or EB. METHODS: Patients were randomly allocated into two equal groups: Group E(n = 29): received EB; Group QL(n = 29): received QLB. Both groups were injected with 0.25% bupivacaine (0.5 ml/kg). Assessment of total analgesia consumption was the primary outcome measure, whereas the secondary outcome measures were assessment of postoperative analgesic effect by Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and time of first analgesic request. RESULTS: Our study showed that the mean total fentanyl consumption was comparable between both groups(38.67 ± 5.02 and 36.47 ± 5.13 µg in the E and QL groups, respectively, P = 0.246). Only five patients did not require rescue analgesia (3 in the E group,2 in the QL group, P = 0.378). The mean duration of analgesia showed no significant difference between the two groups (9.9 ± 1.58 and 11.02 ± 1.74 h in the E and QL groups, respectively, P = 0.212). Evaluation of CHEOPS score values immediately in PACU and for the initial 24 h following operation showed no significant difference between the two study groups(P > 0.05). CONCLUSION: QLB can achieve analgesic effects comparable to those of EB as a crucial part of multimodal analgesia in children undergoing abdominal surgeries. CLINICAL TRIAL REGISTRATION NUMBER: PACTR202203906027106.

A comparative study of respiratory effects of erector spinae plane block versus paravertebral plane block for women undergoing modified radical mastectomy.

BACKGROUND: Inadequate acute postoperative pain control after modified radical mastectomy (MRM) can compromise pulmonary function. This work aimed to assess the postoperative pulmonary effects of a single-shot thoracic paravertebral block (TPVB) and erector spinae plane block (ESPB) in female patients undergoing MRM. METHODS: This prospective, randomized comparative trial was conducted on 40 female American Society of Anesthesiologists (ASA) II-III, aged 18 to 50 years undergoing MRM under general anesthesia (GA). Patients were divided into two equal groups (20 in each group): Group I received ESPB and Group II received TPVB. Each group received a single shot with 20 ml volume of 0.5% bupivacaine. RESULTS: Respiratory function tests showed a comparable decrease in forced vital capacity (FVC) and forced expiratory volume (FEV1) from the baseline in the two groups. Group I had a lower FEV1/FVC ratio than Group II after 6 h. Both groups were comparable regarding duration for the first postoperative analgesic request (P value = 0.088), comparable postoperative analgesic consumption (P value = 0.855), and stable hemodynamics with no reported side effects. CONCLUSION: Both ultrasound guided ESPB and TPVB appeared to be effective in preserving pulmonary function during the first 24 h after MRM. This is thought to be due to their pain-relieving effects, as evidenced by decreased postoperative analgesic consumption and prolonged time to postoperative analgesic request in both groups. GOV ID: NCT03614091 registration date on 13/7/2018.

Regional analgesia using ultrasound-guided intermediate cervical plexus block versus cervical erector spinae block for anterior cervical spine surgery: a randomized trial.

BACKGROUND: Regional analgesia techniques are crucial for pain management after cervical spine surgeries. Anesthesiologists strive to select the most effective and least hazardous regional analgesia technique for the cervical region. Our hypothesis is that an intermediate cervical plexus (IC) block can provide adequate postoperative analgesia compared to a cervical erector spinae (ES) block in patients undergoing anterior cervical spine surgery. METHODS: In this double-blind prospective trial, 58 patients were randomly assigned into two equal groups prior to the administration of general anesthesia. Patients in the IC group (n = 29) underwent ultrasound-guided bilateral intermediate cervical plexus block with 15 ml of bupivacaine 0.25% administered to each side. The ES group (n = 29) underwent ultrasound-guided bilateral cervical erector spinae plane blocks with 15 ml of 0.25% bupivacaine administered to each side at the C6 level. The primary outcome was to record the time to the first call for rescue analgesia (nalbuphine), and the secondary outcomes were to measure the performance time, the onset of the sensory block, the intraoperative fentanyl consumption, postoperative pain intensity using VAS, the postoperative total nalbuphine consumption, and postoperative complications such as nausea, vomiting, hypotension, and bradycardia. RESULTS: The performance and onset of sensory block times were significantly shorter in the IC group compared to the ES group. The time to first call for nalbuphine was significantly shorter in the IC group (7.31 ± 1.34 h) compared to the ES group (11.10 ± 1.82 h). The mean postoperative VAS scores were comparable between the two groups at the measured time points, except at 8 h, where it was significantly higher in the IC group, and at 12 h, where it was significantly higher in the ES group. The total nalbuphine consumption was significantly higher in the IC group (33.1 ± 10.13 mg) compared to the ES group (22.76 ± 8.62 mg). CONCLUSIONS: For patients undergoing anterior cervical spine surgery, the intermediate cervical plexus block does not provide better postoperative regional analgesia compared to the cervical erector spinae block. Performance time and onset time were shorter in the IC group, whereas nalbuphine consumption was lower in the ES group. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov. (NCT05577559, and the date of registration: 13-10-2022).