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超声引导下肌间沟阻滞与锁骨上阻滞用于日间关节镜下肩袖修复术的镇痛效果比较:一项随机非劣效性研究。

Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study.

机构信息

From the Department of Anaesthesiology (JC, TV), Department of Shoulder Surgery, Ramsay Générale de Santé - Hôpital Privé Jean Mermoz, Centre Paul Santy (LN-J), and Department of Anaesthesiology, Ramsay Générale de Santé - Hôpital Privé Claude Galien, Quincy-Sous-Sénard, France (LM).

出版信息

Eur J Anaesthesiol. 2019 Oct;36(10):778-786. doi: 10.1097/EJA.0000000000001065.

DOI:10.1097/EJA.0000000000001065
PMID:31361631
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6738543/
Abstract

BACKGROUND

Ultrasound-guided interscalene block (ISB) is the reference technique for pain control after ambulatory upper limb surgery, but supraclavicular block (SCB) is an alternative.

OBJECTIVES

The aim of this study was to compare the efficacy of SCB vs. ISB in patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR), with the hypothesis of noninferiority of SCB analgesia compared with ISB.

DESIGN

A randomised, single-blind, noninferiority study.

SETTING

Hôpital Privé Jean Mermoz, Centre Paul Santy, Lyon, France.

PATIENTS

Ambulatory ARCR patients.

INTERVENTION

Patients were randomly allocated (1 : 1) to receive a single injection SCB or ISB, as well as general anaesthesia. All patients received a postoperative analgesic prescription for home use before leaving hospital (including fast-acting oral morphine sulphate). Patients completed a telephone questionnaire on days 1 and 2 postsurgery.

MAIN OUTCOME MEASURES

Primary endpoint was oral morphine consumption (mg) during the first 2 days postsurgery. If the difference between mean morphine consumption in the SCB vs. ISB group was less than 30 mg, noninferiority of SCB compared with ISB would be demonstrated. Secondary evaluation criteria included pain scores (numerical rating scale), duration of motor and sensory blockade, and satisfaction with treatment.

RESULTS

The per-protocol cohort included 103 patients (SCB = 52, ISB = 51) (57% men, median age 58 years). Mean morphine consumption in the 48 h postsurgery was 9.4 vs. 14.7 mg in the SCB and ISB groups, respectively (difference -5.3, P < 0.001). The upper limit of the 95% CI was less than 30 mg, demonstrating noninferiority of SCB compared with ISB. No difference was observed between the two groups in terms of pain scores or the duration of motor or sensory blockade. Overall, 98% of patients in the SCB group vs. 90% in the ISB group were satisfied with their treatment.

CONCLUSION

SCB is as effective as ISB in terms of postoperative analgesia based on oral morphine consumption in patients undergoing ambulatory ARCR.

TRIAL REGISTRATION

EudraCT number: 2016-A00747-47.

摘要

背景

超声引导下锁骨下入路阻滞(ISB)是上肢手术术后镇痛的参考技术,但锁骨上入路阻滞(SCB)是另一种选择。

目的

本研究旨在比较 SCB 与 ISB 在接受门诊关节镜下肩袖修复术(ARCR)患者中的疗效,假设 SCB 镇痛效果不劣于 ISB。

设计

随机、单盲、非劣效性研究。

地点

法国里昂 Jean Mermoz 私立医院,Paul Santy 中心。

患者

门诊 ARCR 患者。

干预措施

患者被随机分配(1:1)接受单次 SCB 或 ISB 注射,以及全身麻醉。所有患者在出院前都收到了一份术后家庭使用的镇痛处方(包括速释口服硫酸吗啡)。患者在术后第 1 天和第 2 天通过电话完成问卷。

主要观察指标

主要终点是术后第 1 天和第 2 天的口服吗啡消耗量(mg)。如果 SCB 与 ISB 组的平均吗啡消耗量差异小于 30mg,则证明 SCB 不劣于 ISB。次要评估标准包括疼痛评分(数字评分量表)、运动和感觉阻滞持续时间以及治疗满意度。

结果

符合方案的队列包括 103 例患者(SCB=52 例,ISB=51 例)(57%为男性,中位年龄 58 岁)。术后 48 小时内 SCB 组和 ISB 组的吗啡消耗量分别为 9.4mg 和 14.7mg(差异-5.3,P<0.001)。95%CI 的上限小于 30mg,表明 SCB 不劣于 ISB。两组患者在疼痛评分或运动和感觉阻滞持续时间方面无差异。总体而言,SCB 组 98%的患者对治疗满意,而 ISB 组为 90%。

结论

在接受门诊 ARCR 的患者中,基于口服吗啡消耗量,SCB 在术后镇痛方面与 ISB 同样有效。

试验注册

EudraCT 编号:2016-A00747-47。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71a3/6738543/1ada4da47c8c/ejanet-36-778-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71a3/6738543/d48aa03b7e50/ejanet-36-778-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71a3/6738543/1ada4da47c8c/ejanet-36-778-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71a3/6738543/d48aa03b7e50/ejanet-36-778-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71a3/6738543/1ada4da47c8c/ejanet-36-778-g002.jpg

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