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一项双盲随机试验,比较妇科肿瘤手术中线剖腹术后外科医生实施的腹横肌平面阻滞与安慰剂的效果。

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

作者信息

Bernard Laurence, Lavecchia Melissa, Trepanier Gabrielle, Mah Sarah, Pokoradi Alida, McGinnis Justin M, Alyafi Mohammad, Glezerson Bryan, Nguyen Julie, Carlson Vanessa, Helpman Limor, Elit Laurie, Jimenez Waldo, Eiriksson Lua, Reade Clare J

机构信息

Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada.

Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada.

出版信息

Am J Obstet Gynecol. 2023 May;228(5):553.e1-553.e8. doi: 10.1016/j.ajog.2023.02.010. Epub 2023 Feb 14.

Abstract

BACKGROUND

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.

OBJECTIVE

This study aimed to evaluate whether surgeon-administered transversus abdominis plane block reduces postoperative opioid requirements and improves clinical outcomes.

STUDY DESIGN

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.

RESULTS

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.

CONCLUSION

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.

摘要

背景

外科医生实施的腹横肌平面阻滞是一种提供术后镇痛的现代方法,该方法是通过经腹膜在腹内斜肌和腹横肌之间的平面注射局部麻醉药,以靶向腹壁前外侧的感觉神经。尽管该技术在许多中心都有应用,但尚未在接受中线剖腹手术的患者中进行前瞻性研究。

目的

本研究旨在评估外科医生实施的腹横肌平面阻滞是否能减少术后阿片类药物的需求量并改善临床结局。

研究设计

在这项双盲、随机、安慰剂对照试验中,在加拿大一家三级学术中心接受中线剖腹手术的疑似或确诊妇科恶性肿瘤患者,在筋膜关闭前被随机分为布比卡因组(外科医生实施的腹横肌平面阻滞,注射40 mL 0.25%布比卡因)或安慰剂组(外科医生实施的腹横肌平面阻滞,注射40 mL生理盐水)。主要结局是术后24小时内接受的阿片类药物总剂量(以吗啡毫克当量计)。次要结局包括24至48小时的阿片类药物剂量、疼痛评分、术后恶心和呕吐、临床肠梗阻发生率、排气时间和住院时间。排除标准包括研究药物的禁忌证、慢性阿片类药物使用史、前腹壁严重粘连妨碍进入注射部位、同期非腹部外科手术以及计划使用椎管内麻醉或镇痛。为了检测阿片类药物需求量降低20%,双侧Ⅰ类错误率为5%,检验效能为80%,计算出每组样本量为36例患者。

结果

2020年10月至2021年11月,38例患者被随机分配到布比卡因组,41例患者被随机分配到安慰剂组。平均年龄为60岁,平均体重指数为29.3。79例患者中有30例(38.0%)采用脐上切口,79例患者中有10例(12.7%)进行了肠切除术。患者和手术特征分布均匀。布比卡因组患者术后24小时内需要98.0±59.2吗啡毫克当量,而安慰剂组患者需要100.8±44.0吗啡毫克当量(P = 0.85)。干预组术后4小时的平均疼痛评分为3.1±2.4(0至10分制),安慰剂组为3.1±2.0(P = 0.93)。干预组38例患者中有1例(2.6%)报告有临床意义的恶心或呕吐,安慰剂组41例患者中有1例(2.4%)(P = 0.95)。两组的首次排气时间、临床肠梗阻发生率和住院时间相似。对体重指数<25的患者和接受脐下切口的患者进行亚组分析,结果显示结局同样具有可比性。

结论

对于接受中线剖腹手术的患者,未发现外科医生实施的布比卡因腹横肌平面阻滞在减少术后阿片类药物需求量或改善其他术后结局方面优于安慰剂干预。这些结果与之前评估超声引导下腹横肌平面阻滞方法的报告不同。外科医生实施的腹横肌平面阻滞不应被视为术后多模式镇痛的标准治疗方法。

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