5%利多卡因贴剂用于单侧腹股沟疝修补术后患者的术后疼痛管理的疗效和安全性：一项前瞻性、双盲、随机、对照临床试验的研究方案。

Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial.

机构信息

Department of Surgery, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam, 13620, South Korea.

Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam, 13620, South Korea.

出版信息

Trials. 2022 Sep 11;23(1):767. doi: 10.1186/s13063-022-06700-3.

DOI:10.1186/s13063-022-06700-3

PMID:36089597

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9465907/

Abstract

BACKGROUND

Acute postoperative pain is a common complication of inguinal hernia repair. Pain management using local application of anesthetic agents over the skin surrounding the surgical incision may reduce the requirement for other pain medications. Targeted topical analgesics such as 5% lidocaine patches have been known to improve acute and chronic pain. However, the clinical effect of lidocaine patches on postoperative pain after inguinal hernia repair has not been studied, especially in patients undergoing surgery at day surgery units.

METHODS/DESIGN: This is a single-center, prospective, double-blind, randomized, controlled clinical trial. Participants with unilateral inguinal hernia will be randomized to the lidocaine patch group or the placebo patch group. Based on the randomized allocation sequence, either lidocaine patches or placebo patches will be attached near each participant's surgical wound after open hernia repair under general anesthesia. Participants will be asked to follow up at our outpatient clinic on the first postoperative day and at 1 week after surgery. The primary outcome is pain intensity, which will be measured using the visual analog scale (VAS) at the time of discharge from the day surgery unit. The secondary outcomes are VAS score at 24 h and 1 week after surgery. We will collect and analyze the participants' clinical data (amount of intraoperative opioid use, time to recovery, and pain intensity at 30 min after surgery) and demographic characteristics (age, sex, body weight, and height).

DISCUSSION

This trial may not only provide evidence on the efficacy of a 5% lidocaine patch for acute postoperative pain management after unilateral inguinal hernia repair, but also demonstrate the efficacy and safety of the patch for post-discharge pain management.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04754451. Registered on February 10, 2021.

摘要

背景

急性术后疼痛是腹股沟疝修补术后的常见并发症。通过在手术切口周围的皮肤局部应用麻醉剂进行疼痛管理，可以减少对其他止痛药的需求。局部靶向镇痛剂，如 5%利多卡因贴剂，已被证明可以改善急性和慢性疼痛。然而，尚未研究利多卡因贴剂在腹股沟疝修补术后的术后疼痛中的临床效果，尤其是在日间手术病房中接受手术的患者。

方法/设计：这是一项单中心、前瞻性、双盲、随机、对照临床试验。单侧腹股沟疝患者将被随机分为利多卡因贴剂组或安慰剂贴剂组。根据随机分配序列，在全身麻醉下进行开放疝修补术后，将利多卡因贴剂或安慰剂贴剂贴在每个参与者的手术伤口附近。参与者将在术后第 1 天和术后 1 周在我们的门诊诊所进行随访。主要结局是疼痛强度，将在日间手术病房出院时使用视觉模拟评分（VAS）进行测量。次要结局是术后 24 小时和 1 周时的 VAS 评分。我们将收集和分析参与者的临床数据（术中阿片类药物使用量、恢复时间和术后 30 分钟时的疼痛强度）和人口统计学特征（年龄、性别、体重和身高）。