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脂质体布比卡因与罗哌卡因用于老年股骨转子间骨折患者术前镇痛的髂筋膜间隙阻滞比较疗效:一项随机对照试验方案

Comparative efficacy of fascia iliaca compartment block using liposomal bupivacaine versus ropivacaine for preoperative analgesia in elderly patients with intertrochanteric femur fracture: a randomised controlled trial protocol.

作者信息

Zhang Yu, Qin Zhijun, Dong Jing, Zhang Chong, Feng Ji, Wang Wencan, Yin Chenzhu, Liu Lei

机构信息

Department of Anesthesiology, Sichuan Province Orthopedic Hospital, Chengdu, Sichuan, China.

Department of Anesthesiology, Sichuan Province Orthopedic Hospital, Chengdu, Sichuan, China

出版信息

BMJ Open. 2025 Jul 16;15(7):e093756. doi: 10.1136/bmjopen-2024-093756.

Abstract

INTRODUCTION

Intertrochanteric femur fractures are common in the elderly, with effective pain management being crucial. Fascia iliaca compartment block (FICB) is a well-established method for preoperative analgesia in these patients, but whether liposomal bupivacaine is more effective for this application remains uncertain. This trial aims to evaluate whether liposomal bupivacaine provides superior preoperative analgesia compared to ropivacaine in elderly patients with intertrochanteric femur fracture.

METHODS

This randomised controlled trial will include 84 elderly patients with intertrochanteric femur fracture. Participants will be randomised to receive either liposomal bupivacaine (n=42) or ropivacaine (n=42) via FICB. The outcomes assessed will include pain intensity, anxiety, sleep quality, additional analgesic requirements and rebound pain from FICB administration until preprocedure. Additionally, the study will evaluate in-hospital complications, as well as clinical outcomes at 30 days postsurgery.

ETHICS AND DISSEMINATION

Approved by the Ethics Committee of Sichuan Province Orthopaedic Hospital (Approval No. KY2023-045-01), the study will be published in a peer-reviewed journal. Results will offer evidence-based insights into optimal preoperative analgesia for this patient population.

TRIAL REGISTRATION NUMBER

ChiCTR2400082747.

摘要

引言

股骨转子间骨折在老年人中很常见,有效的疼痛管理至关重要。髂筋膜间隙阻滞(FICB)是这些患者术前镇痛的成熟方法,但脂质体布比卡因在此应用中是否更有效仍不确定。本试验旨在评估在老年股骨转子间骨折患者中,脂质体布比卡因与罗哌卡因相比是否能提供更优的术前镇痛效果。

方法

这项随机对照试验将纳入84例老年股骨转子间骨折患者。参与者将被随机分组,通过FICB接受脂质体布比卡因(n = 42)或罗哌卡因(n = 42)。评估的结果将包括疼痛强度、焦虑、睡眠质量、额外镇痛需求以及从FICB给药到术前的反弹疼痛。此外,该研究将评估住院期间的并发症以及术后30天的临床结局。

伦理与传播

该研究经四川省骨科医院伦理委员会批准(批准号KY2023 - 045 - 01),将发表在同行评审期刊上。结果将为该患者群体的最佳术前镇痛提供基于证据的见解。

试验注册号

ChiCTR2400082747。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6a1a/12273064/98b5010b89c9/bmjopen-15-7-g001.jpg

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