研究动态
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一项双盲、随机试验,比较妇科肿瘤手术中医生实施横腹直肌平面(TAP)阻滞与安慰剂的效果。

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

发表日期:2023 Feb 13
作者: Laurence Bernard, Melissa Lavecchia, Ms Gabrielle Trepanier, Sarah Mah, Alida Pokoradi, Justin M McGinnis, Mohammad Alyafi, Bryan Glezerson, Julie My Van Nguyen, Vanessa Carlson, Limor Helpman, Laurie Elit, Waldo Jimenez, Lua Eiriksson, Clare J Reade
来源: Am J Obstet Gynecol

摘要:

TAP块(横腹肌腹外侧支)是一种现代的术后镇痛方法,由外科医生经腹膜注射局部麻醉剂于内外斜肌之间的平面,以定位腹壁前外侧的感觉神经。虽然在许多中心使用,但该技术尚未在接受中线腹切术的患者中进行前瞻性研究。本研究旨在评估外科医生进行的TAP块是否能降低术后麻醉剂量并改善临床结果。本次双盲、随机、安慰剂对照试验,于加拿大一所三级学术医疗中心接受经典型腹切术治疗的疑似或确认的妇科恶性肿瘤患者被随机分配到接受40毫升0.25%布比卡因或生理盐水(安慰剂)的双侧外科医生进行的TAP块治疗组,在腱膜闭合前注射。主要结果是术后24小时内的麻醉剂量(吗啡当量)。次要结果包括24至48小时之间的麻醉剂量、疼痛评分、术后恶心呕吐的发生率、临床性肠梗阻、排气时间和住院时间。排除标准包括对研究药物的禁忌症、慢性麻醉剂使用史、前腹壁粘连阻止注射部位、同时进行非腹部手术和计划使用神经轴麻醉/镇痛剂的情况。为了检测麻醉剂量减少20%,类型1错误为5%,能力为80%的情况下,每组36名患者计算样本量。从2020年10月到2021年11月,38名患者随机分配到布比卡因组,41名患者随机分配到安慰剂组。平均年龄60岁,平均身体质量指数为29.3。38%(30/79)的病例使用了脐上切口,12.7%(10/79)的病例进行了肠切除术。患者和手术特征均匀分布。接受布比卡因TAP块的患者术后24小时需要98±59.2毫克吗啡当量(MME),安慰剂组接受了100.8±44 MME(p=0.85)。术后4小时的平均疼痛评分为3.1±2.4(0-10分),TAP组与安慰剂组相同(p=0.93)。临床上有意义的恶心或呕吐的发生率分别为介入组的2.6%(1/38),与安慰剂组的2.4%(1/41)相同(p=0.95)。第一次排气时间、临床性肠梗阻的比率和住院时间在两组之间相似。对体质指数<25的患者和接受脐下切口的患者进行亚组分析显示出类似的结果。在这项试验中,外科医生进行的布比卡因TAP块治疗未被证明优于安慰剂,不能降低接受中线腹切术患者的术后麻醉剂量或改善其他术后结果。这些结果与评估超声引导的TAP块治疗的先前报告不同。外科医生进行的TAP块不应被视为术后多模式镇痛的标准护理。Copyright © 2023 Elsevier Inc. All rights reserved.
Surgeon-administered Transversus Abdominis Plane (TAP) block is a contemporary approach to providing postoperative analgesia, and is performed by transperitoneally injecting local anaesthetic in the plane between the internal oblique and transversus abdominis muscles to target the sensory nerves of the anterolateral abdominal wall. While used in many centers, this technique has not been studied prospectively in patients undergoing a midline laparotomy.The purpose of this study was to evaluate whether surgeon-administered TAP blocks reduce postoperative opioid requirements and improve 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 one Canadian tertiary academic center were randomized to receive bilateral surgeon-administered TAP blocks with a total of 40 mL of either 0.25% bupivacaine or normal saline (placebo), prior to fascial closure. The primary outcome was the total dose of opioids (in morphine equivalents) received in the first 24 postoperative hours. 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. 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 non-abdominal surgical procedure and the planned use of neuraxial anaesthesia/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 to the placebo arm. The mean age was 60 years and mean body mass index was 29.3. A supra-umbilical incision was used in 38% (30/79) of cases and bowel resection was performed in 12.7% (10/79) of cases. Patient and surgical characteristics were evenly distributed. The patients who received the bupivacaine TAP block required 98 ± 59.2 morphine milligram equivalents (MME) in the first 24 hours after surgery, while the placebo group received 100.8±44 MME (p=0.85). The mean pain score at 4 hours after surgery was 3.1±2.4 (0-10 scale) in the TAP group, versus 3.1±2 in the placebo group (p=0.93). Clinically significant nausea or vomiting was reported in 2.6% (1/38) of the intervention group, versus 2.4% (1/41) (p=0.95). Time to first flatus, rates of clinical ileus and length-of-stay were similar between groups. Subgroup analysis of patients with body mass index <25 and patients who received an infra-umbilical incision showed similarly comparable outcomes.In this trial, surgeon-administered bupivacaine TAP block was not found to be superior to placebo in reducing postoperative opioid requirements or improving other postoperative outcomes for patients undergoing a midline laparotomy. These results differ from previous reports evaluating ultrasound-guided TAP block administration. Surgeon-administered TAP should not be considered standard of care in postoperative multimodal analgesia.Copyright © 2023 Elsevier Inc. All rights reserved.