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剖宫产术后 5%利多卡因贴剂的镇痛效果:一项随机安慰剂对照双盲临床试验。

Analgesic effects of a 5% lidocaine patch after cesarean section: A randomized placebo-controlled double-blind clinical trial.

机构信息

Botucatu Medical School, São Paulo State University (UNESP), Av. Prof. Mário Rubens Guimarães Montenegro, s/n 18618687, Botucatu, SP, Brazil.

Medical School, Campina Grande Federal University Rua Aprigio Veloso, 882 58429-900 Campina Grande, PB, Brazil.

出版信息

J Clin Anesth. 2021 Oct;73:110328. doi: 10.1016/j.jclinane.2021.110328. Epub 2021 May 8.

Abstract

STUDY OBJECTIVE

This study aimed to evaluate the analgesic effects of a 5% lidocaine patch in acute postoperative pain after cesarean section.

DESIGN

This is a prospective, randomized, double-blind study.

SETTING

After surgery, active and placebo patches were applied in the operating room, and patients were evaluated during their stay at the postoperative recovery room and at the hospital ward.

PATIENTS

Seventy-two women (18 years of age or older and American Society of Anesthesiologists status II) scheduled for cesarean section under spinal anesthesia were enrolled in the study.

INTERVENTIONS

Patients were randomly assigned to an intervention or placebo group. According to the assigned group, a 5% lidocaine patch or a placebo patch was applied 1 cm above and below the Pfannenstiel incision after the surgery.

MEASUREMENTS

The primary outcome was the pain score, evaluated using an 11-point numerical verbal scale in the first 36 h postoperatively. Secondary outcomes were the quality of recovery 24 h after surgery, consumption of rescue opioids, and the presence of adverse effects.

MAIN RESULTS

Sixty-five women completed the study. The pain score was lower in the lidocaine group at 6 h (lidocaine group: 2.16 ± 1.71, placebo group: 3.21 ± 2.25; p = 0.031), 12 h (lidocaine: 1.58 ± 0.81, placebo: 2.24 ± 0.74; p = 0.001), 24 h (lidocaine: 0.74 ± 0.89, placebo: 1.94 ± 1.39; p < 0.0001), and 36 h (lidocaine: 0.48 ± 1.03, placebo: 1.68 ± 0.94; p = 0.001) after surgery. There were no differences in secondary outcomes during the follow-up period.

CONCLUSION

The lidocaine patch reduced pain scores compared to placebo in the first 36 h after the surgery, despite no influence over opioid consumption, quality of recovery, or incidence of side effects.

摘要

研究目的

本研究旨在评估 5%利多卡因贴剂在剖宫产术后急性疼痛中的镇痛效果。

设计

这是一项前瞻性、随机、双盲研究。

地点

手术后,在手术室中使用活性和安慰剂贴剂,在术后恢复室和医院病房对患者进行评估。

患者

72 名年龄在 18 岁及以上且美国麻醉医师协会(ASA)分级为 II 级的妇女被纳入本研究,她们拟在脊髓麻醉下接受剖宫产术。

干预措施

患者被随机分配到干预组或安慰剂组。根据分组,手术后在 Pfannenstiel 切口上方和下方 1cm 处贴敷 5%利多卡因贴剂或安慰剂贴剂。

测量

主要结局是术后 36 小时内使用 11 点数字言语量表评估的疼痛评分。次要结局包括术后 24 小时时的恢复质量、阿片类药物解救的消耗以及不良反应的发生。

主要结果

65 名妇女完成了研究。在术后 6 小时(利多卡因组:2.16±1.71,安慰剂组:3.21±2.25;p=0.031)、12 小时(利多卡因组:1.58±0.81,安慰剂组:2.24±0.74;p=0.001)、24 小时(利多卡因组:0.74±0.89,安慰剂组:1.94±1.39;p<0.0001)和 36 小时(利多卡因组:0.48±1.03,安慰剂组:1.68±0.94;p=0.001)时,利多卡因组的疼痛评分低于安慰剂组。在随访期间,次要结局没有差异。

结论

与安慰剂相比,利多卡因贴剂在术后 36 小时内降低了疼痛评分,尽管对阿片类药物消耗、恢复质量或不良反应发生率没有影响。

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