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肺切除术后肋间导管局部罗哌卡因镇痛的疗效:一项随机、双盲、安慰剂对照、优效性研究。

The efficacy of loco-regional ropivacaine analgesia via intercostal catheters after lung resection: a randomized, double-blind, placebo-controlled, superiority study.

机构信息

Department of Thoracic Surgery, University Hospital Basel, University of Basel, Basel, Switzerland.

Clinic for Anesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, University of Basel, Basel, Switzerland.

出版信息

Eur J Cardiothorac Surg. 2024 Oct 1;66(4). doi: 10.1093/ejcts/ezae342.

Abstract

OBJECTIVES

Postoperative pain remains a burden for patients after minimally invasive anatomic lung resection. Current guidelines recommend the intraoperative placement of intercostal catheters to promote faster recovery. This trial aimed to determine the analgesic efficacy of continuous loco-regional ropivacaine application via intercostal catheter and establish this method as a possible standard of care.

METHODS

Between December 2021 and October 2023, patients were randomly assigned to receive ropivacaine 0.2% or a placebo through an intercostal catheter with a flow rate of 6-8 ml/h for 72 h after surgery. Patients were undergoing anatomic VATS lung resection under general anaesthesia for confirmed or suspected stage I lung cancer (UICC, 8th edition). The sample size was calculated to assess a difference in numerical rating scale associated with pain reduction of 1.5 points.

RESULTS

Fourteen patients were included in the ropivacaine group, whereas the placebo group comprised 18 participants. Patient characteristics and preoperative pain scores were similar in both groups. There was no statistically significant difference in postoperative pain scores and morphine consumption between the 2 groups. The mean numerical rating scale when coughing during the first 24 h postoperatively was 4.9 (SD: 2.2) in the ropivacaine group and 4.3 (SD: 2.4); P = 0.47 in the placebo group. We were unable to determine any effect of administered ropivacaine on the postoperative pulmonary function (FEV1, PEF).

CONCLUSIONS

Our preliminary results suggest that continuous loco-regional ropivacaine administration via surgically placed intercostal catheter has no positive effect on postoperative pain scores or morphine requirements.

CLINICAL REGISTRATION NUMBER

NCT04939545.

摘要

目的

微创解剖性肺切除术后,患者仍存在术后疼痛问题。目前的指南建议术中放置肋间导管以促进更快的康复。本试验旨在确定通过肋间导管持续局部应用罗哌卡因的镇痛效果,并将这种方法确立为一种可能的常规护理方法。

方法

2021 年 12 月至 2023 年 10 月,患者随机分配到罗哌卡因 0.2%或安慰剂组,通过术后 72 小时内以 6-8ml/h 的流速通过肋间导管给药。患者在全身麻醉下接受解剖性 VATS 肺切除术,用于确诊或疑似 I 期肺癌(UICC,第 8 版)。样本量的计算旨在评估与疼痛减轻 1.5 点相关的数字评定量表的差异。

结果

罗哌卡因组纳入 14 例患者,安慰剂组纳入 18 例患者。两组患者的特征和术前疼痛评分相似。两组术后疼痛评分和吗啡消耗量无统计学差异。术后 24 小时内咳嗽时的平均数字评定量表评分在罗哌卡因组为 4.9(SD:2.2),在安慰剂组为 4.3(SD:2.4);P=0.47。我们无法确定给予罗哌卡因对术后肺功能(FEV1、PEF)有任何影响。

结论

我们的初步结果表明,通过手术放置的肋间导管持续局部给予罗哌卡因对术后疼痛评分或吗啡需求没有积极影响。

临床试验注册号

NCT04939545。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/054f/11470208/d716517b9572/ezae342f4.jpg

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