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肝切除患者围手术期持续静脉输注利多卡因72小时对术后疼痛及恢复的疗效:一项前瞻性随机对照试验的研究方案

Efficacy of Perioperative Continuous Intravenous Lidocaine Infusion for 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: Study Protocol for a Prospective Randomized Controlled Trial.

作者信息

Xu Yan, Ye Mao, Hong Ying, Kang Yi, Li Yue, Xiao Xiao, Zhou Li, Jiang Chunling

机构信息

Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.

Department of Anesthesiology and Translational Neuroscience Center, Laboratory of Anesthesia and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.

出版信息

J Pain Res. 2021 Dec 1;14:3665-3674. doi: 10.2147/JPR.S341550. eCollection 2021.

Abstract

PURPOSE

Many patients develop severe and persistent pain after hepatectomy delaying postoperative rehabilitation. Studies have suggested that intravenous lidocaine infusion relieved postoperative pain and improved overall postoperative outcomes. However, its efficacy on hepatectomy is still masked, due to the postoperative metabolic change of lidocaine by the liver. We hypothesized that intravenous lidocaine infusion in the perioperative period would lead to postoperative pain reduction and improve the overall patient experience.

STUDY DESIGN AND METHODS

In this prospective double-blind, randomized controlled design trial, 260 adults scheduled for hepatectomy will be allocated to the lidocaine and the placebo groups. The lidocaine group will be administered lidocaine intravenously during intraoperative period and 72 postoperative hours; the placebo group will be administered normal saline at the same volume, infusion rate, and timing. The primary outcome is the incidence of moderate-severe pain (numeric rating scale ≥4) during movement at 24 hours after surgery. The secondary outcomes include the incidence of moderate-severe pain at 24 hours after surgery at rest, the incidence of moderate-severe pain at 48 and 72 hours after surgery at rest and during movement, the cumulative morphine consumption at 24, 48 and 72 hours postoperatively, bowel function recovery, the incidence of postoperative nausea and vomiting, the incidence of postoperative pulmonary complications, the length of hospital stay, levels of inflammatory factors and patient satisfaction scores.

DISCUSSION

This is the first prospective trial to shed light on the efficacy of intraoperative period and 72 postoperative hours intravenous lidocaine on postoperative pain and recovery after hepatectomy. The findings will provide a new strategy of perioperative pain management for hepatectomy.

摘要

目的

许多患者在肝切除术后会出现严重且持续的疼痛,这延迟了术后康复。研究表明,静脉输注利多卡因可减轻术后疼痛并改善整体术后结局。然而,由于肝脏对利多卡因的术后代谢变化,其对肝切除术的疗效仍不明确。我们假设围手术期静脉输注利多卡因会减轻术后疼痛并改善患者的整体体验。

研究设计与方法

在这项前瞻性双盲随机对照设计试验中,260名计划接受肝切除术的成年人将被分配到利多卡因组和安慰剂组。利多卡因组将在术中及术后72小时内静脉输注利多卡因;安慰剂组将以相同的体积、输注速率和时间输注生理盐水。主要结局是术后24小时活动时中重度疼痛(数字评分量表≥4) 的发生率。次要结局包括术后24小时静息时中重度疼痛的发生率、术后48小时和72小时静息及活动时中重度疼痛的发生率、术后24、48和72小时吗啡的累积用量、肠功能恢复情况、术后恶心呕吐的发生率、术后肺部并发症的发生率、住院时间、炎症因子水平及患者满意度评分。

讨论

这是第一项揭示术中及术后72小时静脉输注利多卡因对肝切除术后疼痛及恢复疗效的前瞻性试验。研究结果将为肝切除术围手术期疼痛管理提供一种新策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca38/8646227/a42ee7434a1e/JPR-14-3665-g0001.jpg

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