Continuous ropivacaine wound infiltration versus epidural morphine after unplanned caesarean delivery: A noninferiority randomised controlled study.

IF 4.2 2区 医学 Q1 ANESTHESIOLOGY
European Journal of Anaesthesiology Pub Date : 2025-05-01 Epub Date: 2025-02-05 DOI:10.1097/EJA.0000000000002135
Marine Bruillot, Audrey Pieper, Dimitri Sourd, Ana Roge, Edith Ramain, Samia Salah, Jean-Luc Bosson, Jean-Francois Payen
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引用次数: 0

Abstract

Background: Treatment programs designed to enhance recovery after caesarean delivery include multimodal analgesia to ensure optimal analgesia while reducing exposure to systemic opioids. Evidence for the effectiveness of continuous wound infiltration with local anaesthetic after unplanned caesarean delivery is needed.

Objective: To determine whether continuous ropivacaine wound infiltration has noninferior analgesic properties compared to epidural morphine, while reducing side effects related to opioids.

Design: Triple-blinded, noninferiority, randomised controlled trial.

Setting: One university hospital, between February 2015 and August 2021.

Patients: Eighty-one women undergoing unplanned lower segment caesarean section under epidural anaesthesia.

Intervention: At the end of the procedure, randomly assigned patients received either an epidural bolus of 0.9% saline with 48 h continuous ropivacaine wound infusion (ropivacaine group) or an epidural bolus of morphine with 48 h 0.9% saline wound infusion (morphine group).

Main outcome measures: Pain during mobilisation at 24 h postsurgery was assessed using the visual analogue pain scale (VAS 0 to 10) with no indication of the allocated group.

Results: Pain scores were 4.4 (95% CI, 3.6 to 5.1) in the ropivacaine group versus 3.1 (95% CI, 2.4 to 3.9) in the morphine group. The mean VAS pain difference between the two groups was 1.2 (95% CI, 0.2 to 2.3), which exceeded the prespecified noninferiority margin of 1. The differences between the two groups at rest and during mobilisation at 6 and 24 h were statistically significant. The ropivacaine group received rescue morphine more frequently, and were less satisfied despite fewer morphine-related side effects. Continuous wound infiltration was not technically feasible in 18% of the patients.

Conclusions: We failed to show that continuous ropivacaine wound infiltration was noninferior to epidural morphine in providing analgesia after unplanned caesarean delivery. Because of a significant rate of technical failures, continuous wound infiltration should only be considered when neuraxial morphine is contraindicated.

非计划剖宫产后持续罗哌卡因伤口浸润与硬膜外吗啡:一项非劣效性随机对照研究。
背景:旨在提高剖宫产后恢复的治疗方案包括多模式镇痛,以确保最佳镇痛,同时减少全身阿片类药物的暴露。非计划剖宫产后持续伤口浸润局部麻醉的有效性需要证据。目的:探讨罗哌卡因创面持续浸润与硬膜外吗啡相比,是否具有良好的镇痛性能,同时减少阿片类药物的副作用。设计:三盲、非劣效性、随机对照试验。地点:一所大学医院,2015年2月至2021年8月。患者:硬膜外麻醉下行无计划下段剖宫产81例。干预:在手术结束时,随机分配患者接受0.9%生理盐水硬膜外注射并连续48 h罗哌卡因创面输注(罗哌卡因组)或吗啡硬膜外注射并连续48 h 0.9%生理盐水创面输注(吗啡组)。主要结果测量:术后24小时活动时疼痛采用视觉模拟疼痛量表(VAS 0 - 10)进行评估,无分配组指示。结果:罗哌卡因组疼痛评分为4.4 (95% CI, 3.6 ~ 5.1),吗啡组为3.1 (95% CI, 2.4 ~ 3.9)。两组间VAS疼痛的平均差异为1.2 (95% CI, 0.2 ~ 2.3),超过了预定的非劣效性界限1。两组在休息和活动6和24 h时的差异有统计学意义。罗哌卡因组使用吗啡的频率更高,尽管吗啡相关的副作用较少,但满意度较低。18%的患者在技术上不可行。结论:我们未能证明持续罗哌卡因伤口浸润在提供意外剖宫产后镇痛方面优于硬膜外吗啡。由于技术失败率很高,只有当神经轴向吗啡是禁忌时,才应考虑持续伤口浸润。
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来源期刊
CiteScore
6.90
自引率
11.10%
发文量
351
审稿时长
6-12 weeks
期刊介绍: The European Journal of Anaesthesiology (EJA) publishes original work of high scientific quality in the field of anaesthesiology, pain, emergency medicine and intensive care. Preference is given to experimental work or clinical observation in man, and to laboratory work of clinical relevance. The journal also publishes commissioned reviews by an authority, editorials, invited commentaries, special articles, pro and con debates, and short reports (correspondences, case reports, short reports of clinical studies).
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