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静脉利多卡因输注与胸段硬膜外镇痛在腹部大手术中的疗效比较:一项非劣效性随机临床试验。

Therapeutic efficacy of intravenous lidocaine infusion compared with thoracic epidural analgesia in major abdominal surgery: a noninferiority randomised clinical trial.

机构信息

Department of Anaesthesiology, Faculty of Medicine, University of Antioquia, Medellin, Colombia; Department of Surgery, University Hospital of San Vicente Foundation, Medellín, Colombia.

Department of Anaesthesiology, Faculty of Medicine, University of Antioquia, Medellin, Colombia; Department of Anaesthesiology, Hospital Alma Mater de Antioquia, Medellín, Colombia.

出版信息

Br J Anaesth. 2023 Nov;131(5):947-954. doi: 10.1016/j.bja.2023.07.032. Epub 2023 Sep 26.

Abstract

BACKGROUND

Open major abdominal surgery is one of the most risky surgical procedures for acute postoperative pain. Thoracic epidural analgesia (TEA) has been considered the standard analgesic approach. In different reports, lidocaine i.v. has been shown to have an analgesic efficacy comparable with TEA. We compared the analgesic efficacy of i.v. lidocaine with thoracic epidural analgesia using bupivacaine in patients undergoing major abdominal surgery.

METHODS

In this noninferiority clinical trial, 210 patients were randomised to thoracic epidural bupivacaine with morphine or i.v. lidocaine. Dynamic pain at 24 h after surgery was measured using a numerical pain rating scale (NPR), and morphine consumption was also measured. A difference in i.v. the lidocaine-epidural bupivacaine NPR of ≤1 for dynamic pain was considered a noninferiority margin.

RESULTS

The NPR for dynamic pain in the lidocaine group at 24 h was between 5.7 (1.8) and 5.2 (1.9) in the epidural group, with a difference of 0.53 (95% confidence interval 0.0-1.0). In the first 24 h, the average difference in morphine consumption was 1.8 mg between the i.v. lidocaine and epidural groups (95% confidence interval 1-3 mg). No differences were found in adverse events or complications associated with the procedures.

CONCLUSIONS

Intravenous lidocaine is noninferior to thoracic epidural analgesia for acute postoperative pain control in major abdomial surgery at 24 h postoperatively.

CLINICAL TRIALS REGISTRATION

NCT04017013.

摘要

背景

开放性腹部大手术是急性术后疼痛风险最高的手术之一。胸椎硬膜外镇痛(TEA)被认为是标准的镇痛方法。在不同的报告中,静脉内利多卡因已被证明具有与 TEA 相当的镇痛效果。我们比较了静脉内利多卡因与布比卡因用于接受大腹部手术的患者的胸椎硬膜外镇痛的镇痛效果。

方法

在这项非劣效性临床试验中,210 名患者被随机分配到胸椎硬膜外布比卡因联合吗啡或静脉内利多卡因。使用数字疼痛评分量表(NPR)测量手术后 24 小时的动态疼痛,并测量吗啡的消耗量。静脉内利多卡因-硬膜外布比卡因 NPR 的差异≤1 被认为是动态疼痛的非劣效性边界。

结果

利多卡因组在 24 小时时的 NPR 为 5.7(1.8)和 5.2(1.9),硬膜外组为 5.2(1.9),差异为 0.53(95%置信区间 0.0-1.0)。在最初的 24 小时内,静脉内利多卡因组和硬膜外组之间吗啡消耗量的平均差异为 1.8 毫克(95%置信区间 1-3 毫克)。两种方法在与程序相关的不良事件或并发症方面没有差异。

结论

在术后 24 小时,静脉内利多卡因与胸椎硬膜外镇痛相比,在控制大腹部手术后急性术后疼痛方面非劣效。

临床试验注册

NCT04017013。

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