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静脉注射利多卡因对头颈部癌症手术后疼痛的影响(ELICO 试验):一项随机对照试验。

Effect of intravenous lidocaine on pain after head and neck cancer surgery (ELICO trial): A randomised controlled trial.

机构信息

From the Département d'anesthésie-réanimation, Centre Léon Bérard (GW, JE, GA, JLS), Département d'anesthésie-réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon (EO, CB, FA), Centre de recherche clinique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon (ST), and Research on Healthcare Performance (RESHAPE), U1290, INSERM et Université Claude Bernard Lyon 1, Lyon, France (FA).

出版信息

Eur J Anaesthesiol. 2022 Sep 1;39(9):735-742. doi: 10.1097/EJA.0000000000001712. Epub 2022 Jul 20.

DOI:10.1097/EJA.0000000000001712
PMID:35852564
Abstract

BACKGROUND

Treatment of postoperative pain after ear, nose and throat (ENT) cancer surgery is mainly morphine administration. Additional systemic lidocaine has shown promising results in some surgical procedures.

OBJECTIVE

The main objective was to evaluate morphine consumption in the first 48 postoperative hours after intra-operative lidocaine infusion during major ENT cancer surgery.

DESIGN

A randomised, double-blind, placebo-controlled trial.

SETTING

Bicentric study including a university hospital and a major cancer centre, conducted from December 2016 to December 2019.

PATIENTS

A total of 144 patients undergoing major ENT cancer surgery were included.

INTERVENTION

The patients were randomly assigned to receive intravenous lidocaine or placebo during surgery and in the recovery room.

MAIN OUTCOME MEASURES

Endpoints were postoperative morphine consumption in the first 24 and 48 h postoperatively, intra-operative remifentanil consumption, adverse events occurrence and assessment 3 to 6 months after surgery with the McGill pain questionnaire.

RESULTS

A total of 118 patients were included (lidocaine n  = 57; placebo n  = 61, 26 patients were excluded). There was no significant difference in morphine consumption during the first 48 postoperative hours in the lidocaine group compared with the placebo group with a median [IQR] of 0.60 [0.30 to 1.03] mg kg -1 vs. 0.57 [0.37 to 0.96] mg kg -1 , total dose 44 [21 to 73.3] mg vs. 38 [23.3 to 56.5] mg, P  = 0.92.There was no significant difference between the two groups in any of the other endpoints, including at follow up 3 to 6 months after surgery.

CONCLUSION

Intravenous lidocaine in ENT cancer surgery did not show any additional analgesic or morphine-sparing effect 48 h after surgery. Three to six months after surgery, there was no significant difference in pain scores or consumption of analgesics. Patients treated pre-operatively with opioids were not evaluated in the study.

TRIAL REGISTRATION

Clinicaltrials.gov identifier: NCT02894710 and EUDRACT number 2015-005799-90.

摘要

背景

耳鼻喉(ENT)癌手术后的疼痛治疗主要是使用吗啡。在一些手术中,额外给予全身利多卡因显示出有希望的结果。

目的

主要目的是评估在接受主要 ENT 癌症手术后术中给予利多卡因输注后的前 48 小时内吗啡的消耗量。

设计

一项随机、双盲、安慰剂对照试验。

地点

包括大学医院和主要癌症中心的双中心研究,于 2016 年 12 月至 2019 年 12 月进行。

患者

共纳入 144 名接受主要 ENT 癌症手术的患者。

干预

患者在手术中和恢复室中随机分配接受静脉内利多卡因或安慰剂。

主要观察指标

术后前 24 小时和 48 小时的术后吗啡消耗量、术中瑞芬太尼消耗量、术后 3 至 6 个月的不良事件发生情况,并使用麦吉尔疼痛问卷进行评估。

结果

共纳入 118 名患者(利多卡因组 n=57;安慰剂组 n=61,26 名患者被排除)。利多卡因组与安慰剂组在术后 48 小时内吗啡消耗量无显著差异,中位数[IQR]分别为 0.60[0.30 至 1.03]mg·kg -1 与 0.57[0.37 至 0.96]mg·kg -1 ,总剂量 44[21 至 73.3]mg 与 38[23.3 至 56.5]mg,P=0.92。两组在其他所有终点均无显著差异,包括术后 3 至 6 个月的随访。

结论

在 ENT 癌症手术中,静脉内利多卡因在术后 48 小时内没有显示出任何额外的镇痛或吗啡节省效果。术后 3 至 6 个月,疼痛评分或镇痛药消耗无显著差异。在研究中未评估术前接受阿片类药物治疗的患者。

试验注册

Clinicaltrials.gov 标识符:NCT02894710 和 EUDRACT 编号 2015-005799-90。

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