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经皮丁丙诺啡贴剂与常规镇痛药在股骨近端囊外骨折术后固定中的疗效和安全性比较。

Comparison of the efficacy and safety of transdermal buprenorphine patch to conventional analgesics after operative fixation of extra capsular fracture of proximal femur.

机构信息

Consultant Orthopedic Surgeon, Criticare Asia Hospital, Andheri, Mumbai, India.

Consultant Anesthesiologist, Criticare Asia Hospital, Andheri, India.

出版信息

Injury. 2024 Jun;55 Suppl 2:111395. doi: 10.1016/j.injury.2024.111395. Epub 2024 Aug 2.

Abstract

INTRODUCTION

Proximal femur fractures are common among older individuals and pose challenges in achieving effective post-operative analgesia. Age-related co-morbidities limit the selection of analgesics in this population. This study aimed to compare the safety and effectiveness of transdermal buprenorphine (TDB) patch with traditional analgesics after fixation of an extracapsular fracture of the proximal femur.

METHODOLOGY

A prospective randomized controlled study was conducted over a 2-year period, involving 60 patients who underwent surgery for extra capsular intertrochanteric fracture fixation. The patients were randomly assigned to two groups by random envelope method. Group A received an intravenous formulation of paracetamol and tramadol for the initial 48 h, followed by an oral formulation. Group B received a transdermal buprenorphine (TDB) patch delivering 5 mcg/hour immediately after surgery, which continued for 2 weeks postoperatively. During the 14-day monitoring period, patients' pain scores were assessed using the Visual Analog Scale (VAS) at rest and during movement. The primary objective was to maintain a VAS score of 4 or lower. Rescue analgesics were administered if the VAS score reached 6. The secondary objectives included evaluating the quantity of rescue analgesics required and monitoring for any adverse effects or complications.

RESULTS

Pain scores at rest and during movement were significantly lower in Group B at all-time points (p-value 0.0006 - ≤ 0.0001), and the requirement for rescue analgesia was also significantly lower in this group. The administration of the TDB patch did not result in any significant adverse effects.

CONCLUSION

TDB patch is secure and offers better compliance and analgesia than other analgesics in the postoperative period whilst treating proximal femur extra capsular fracture.

摘要

简介

股骨近端骨折在老年人中较为常见,术后有效镇痛具有挑战性。与年龄相关的合并症限制了此类人群中镇痛药的选择。本研究旨在比较经皮丁丙诺啡(TDB)贴剂与传统镇痛药在治疗股骨近端囊外骨折固定后的安全性和有效性。

方法

一项为期 2 年的前瞻性随机对照研究,共纳入 60 例行股骨近端囊外骨折固定术的患者。采用随机信封法将患者随机分为两组。A 组在术后最初 48 小时内接受静脉注射对乙酰氨基酚和曲马多,然后口服。B 组在术后立即给予透皮丁丙诺啡(TDB)贴剂,每贴 5 mcg/h,持续 2 周。在 14 天的监测期内,使用视觉模拟评分(VAS)评估患者的静息和运动时疼痛评分。主要目标是维持 VAS 评分在 4 分以下。如果 VAS 评分达到 6 分,则给予解救性镇痛。次要目标包括评估所需解救性镇痛的数量以及监测任何不良反应或并发症。

结果

在所有时间点,B 组的静息和运动时疼痛评分均显著低于 A 组(p 值均<0.0006 至 ≤0.0001),B 组需要解救性镇痛的患者也明显较少。TDB 贴剂的使用并未导致任何显著的不良反应。

结论

TDB 贴剂在治疗股骨近端囊外骨折后具有良好的安全性,与其他镇痛药相比,能提供更好的依从性和镇痛效果。

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