局部应用氨甲环酸与安慰剂对桡骨远端骨折内固定术后急性疼痛的影响：四级护理手外科中心的一项随机对照试验方案——TRADR研究

The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre - The TRADR study.

作者信息

Lameire Darius Luke, Noori Atefeh, Abbas Aazad, Persitz Jonathan, Baltzer Heather, Collett Emily, Veillette Christian, Chan Andrea, Paul Ryan

机构信息

Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, University Health Network; Toronto Western Hand Program, University of Toronto, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2025 May 21;15(5):e095684. doi: 10.1136/bmjopen-2024-095684.

DOI:10.1136/bmjopen-2024-095684

PMID:40398932

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12097037/

Abstract

INTRODUCTION

Postoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient's satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.

METHODS AND ANALYSIS

The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events.

ETHICS AND DISSEMINATION

This study was approved by the University Health Network Research Ethics Board (REB 23-5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results.

TRIAL REGISTRATION NUMBER

Clinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment.

PROTOCOL VERSION

Version 2.0: August 26, 2024.

摘要

引言

桡骨远端切开复位内固定术（ORIF）患者的术后疼痛管理是一个主要问题。疼痛控制不佳会对患者满意度产生负面影响，并可能增加阿片类药物的使用。局部应用氨甲环酸（TXA）已被证明是一种有效的干预措施，可减轻全膝关节置换术后的急性疼痛。目前尚无评估TXA对桡骨远端ORIF术后急性疼痛影响的研究。本研究旨在评估在单纯桡骨远端ORIF术中局部应用TXA对术后早期疼痛的影响。

方法与分析

局部应用氨甲环酸与安慰剂对桡骨远端骨折固定术后急性疼痛的影响（TRADR）研究是一项随机对照双盲试验，将招募90名18岁及以上接受掌侧切开复位内固定术的患者。患者将按1:1的比例随机分配至局部应用TXA组与局部应用生理盐水（安慰剂）组。在标准桡骨远端固定术后手术闭合时，外科医生将向伤口应用1g局部TXA（100mg/mL；治疗组）或10mL生理盐水（对照组），并使其停留5分钟。外科医生、患者和结果评估者将对治疗组情况不知情。主要结局是通过视觉模拟量表（VAS）测量的术后急性疼痛。疼痛结局将在术后第0至7天以及术后2周和6周进行评估。次要结局包括阿片类药物使用情况、非计划急诊就诊、腕部肿胀和不良事件。