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一项双盲,随机试验,比较外科医生的腹部横向平面块与妇科肿瘤手术的中线腹腔切开术后安慰剂

A double-blinded, randomized trial comparing surgeon-administered transversus abdominis plane block with placebo after midline laparotomy in gynecologic oncology surgery

影响因子:8.40000
分区:医学1区 Top / 妇产科学1区
发表日期:2023 May
作者: Laurence Bernard, Melissa Lavecchia, Gabrielle Trepanier, Sarah Mah, Alida Pokoradi, Justin M McGinnis, Mohammad Alyafi, Bryan Glezerson, Julie Nguyen, Vanessa Carlson, Limor Helpman, Laurie Elit, Waldo Jimenez, Lua Eiriksson, Clare J Reade

摘要

外科医生管理的横向腹部平面块是一种提供术后镇痛的现代方法,这种方法是通过腹膜内的,在腹部肌肉和横向腹部肌肉之间的平面中施用局部麻醉剂来靶向腹侧外侧腹侧外侧的感觉神经的感觉。尽管该技术在许多中心都使用,但尚未对正在进行中线剖腹手术的患者进行前瞻性研究。该研究旨在评估外科医生在外科医生腹部的腹部平面障碍是否降低了阿片类药物的要求并改善了临床临床的临床临床,或者通过这种双重欺骗,置于多双重的审判范围内,该疾病的临床范围是孔径,地位,地位验证了,地位验证了gy,gy症状的gy症状。在1个加拿大三级学术中心的中线剖腹切开术被随机分为布比卡因组(外科医生的腹部横向腹部腹部平面块,具有40 ml的0.25%bupivacaine)或安慰剂组或安慰剂组(外科医生辅助抗abdysprans blangs blangs ting a 40 ml salline salline salline salline salline salline salline salline salline salline salline salline salline salline salline blangs blocks)fordical salline salline。主要结果是在手术后的头24小时内收到的阿片类药物总剂量(在吗啡毫克等效物中)。次要结局包括24至48小时之间的阿片类药物剂量,疼痛评分,术后恶心和呕吐,临床回肠的发病率,fterus的时间以及住院时间。排除标准包括研究药物治疗的禁忌症,慢性阿片类药物使用史,前腹壁上的显着粘附,以防止进入注射部位,并发非腹部手术程序以及计划使用神经性麻醉或镇痛。为了检测阿片类药物的需求降低20%,2型1型误差为5%,功率为80%,每组的样本量为36例。平均年龄为60岁,平均体重指数为29.3。在79例(38.0%)中的30例中使用了上切口,在79例(12.7%)中有10例(12.7%)进行了肠切除。患者和手术特征均匀分布。布比卡因组的患者在手术后的头24小时需要98.0±59.2吗啡毫克等效物,而安慰剂组的患者则需要100.8±44.0吗啡毫克等效物(p = .85)。手术后4小时的平均疼痛评分为3.1±2.4(0-10比例),在安慰剂组中为3.1±2.0(p = .93)。在安慰剂组中,在38例患者中有1例中有1例中有1例(2.4%)的38例患者中有1例中有1例(2.6%)报道了临床上显着的恶心或呕吐(p = .95)。两组之间的第一个肠胃,临床回肠率和住院时间相似。对体重指数<25的患者的亚组分析和接受额外切口的患者表现出类似可比的结果。外ge肌抗腹部的腹部腹部平面块与布比卡因没有比安慰剂干预更优于安慰剂干预,从而减少了术后阿片类药物或改善其他后外的外表术,而不是在其他下落后的外观。这些结果与先前评估超声引导的腹部平面障碍物方法的报告不同。术后多模式镇痛中,外科医生的腹部横向横向阻止性不应被视为护理标准。

Abstract

Surgeon-administered transversus abdominis plane block is a contemporary approach to providing postoperative analgesia, and this approach is performed by transperitoneally administering local anesthetic in the plane between the internal oblique and transversus abdominis muscles to target the sensory nerves of the anterolateral abdominal wall. Although this technique is used in many centers, it has not been studied prospectively in patients undergoing a midline laparotomy.This study aimed to evaluate whether surgeon-administered transversus abdominis plane block reduces postoperative opioid requirements and improves clinical outcomes.In this double-blind, randomized, placebo-controlled trial, patients with a suspected or proven gynecologic malignancy undergoing surgery through a midline laparotomy at 1 Canadian tertiary academic center were randomized to either the bupivacaine group (surgeon-administered transversus abdominis plane blocks with 40 mL of 0.25% bupivacaine) or the placebo group (surgeon-administered transversus abdominis plane blocks with 40 mL of normal saline solution) before fascial closure. The primary outcome was the total dose of opioids (in morphine milligram equivalents) received in the first 24 hours after surgery. The secondary outcomes included opioid doses between 24 and 48 hours, pain scores, postoperative nausea and vomiting, incidence of clinical ileus, time to flatus, and hospital length of stay. The exclusion criteria included contraindications to study medication, history of chronic opioid use, significant adhesions on the anterior abdominal wall preventing access to the injection site, concurrent nonabdominal surgical procedure, and the planned use of neuraxial anesthesia or analgesia. To detect a 20% decrease in opioid requirements with a 2-sided type 1 error of 5% and power of 80%, a sample size of 36 patients per group was calculated.From October 2020 to November 2021, 38 patients were randomized to the bupivacaine arm, and 41 patients were randomized to the placebo arm. The mean age was 60 years, and the mean body mass index was 29.3. A supraumbilical incision was used in 30 of 79 cases (38.0%), and bowel resection was performed in 10 of 79 cases (12.7%). Patient and surgical characteristics were evenly distributed. The patients in the bupivacaine group required 98.0±59.2 morphine milligram equivalents in the first 24 hours after surgery, whereas the patients in the placebo group required 100.8±44.0 morphine milligram equivalents (P=.85). The mean pain score at 4 hours after surgery was 3.1±2.4 (0-10 scale) in the intervention group vs 3.1±2.0 in the placebo group (P=.93). Clinically significant nausea or vomiting was reported in 1 of 38 patients (2.6%) in the intervention group vs 1 of 41 patients (2.4%) in the placebo group (P=.95). Time to first flatus, rates of clinical ileus, and length of stay were similar between groups. Subgroup analysis of patients with a body mass index of <25 and patients who received an infraumbilical incision showed similarly comparable outcomes.Surgeon-administered transversus abdominis plane block with bupivacaine was not found to be superior to the placebo intervention in reducing postoperative opioid requirements or improving other postoperative outcomes for patients undergoing a midline laparotomy. These results differed from previous reports evaluating the ultrasound-guided transversus abdominis plane block approach. Surgeon-administered transversus abdominis plane block should not be considered standard of care in postoperative multimodal analgesia.