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度洛西汀减少全髋关节置换术后疼痛:一项前瞻性、随机对照研究。

Duloxetine reduces pain after Total hip arthroplasty: a prospective, randomized controlled study.

机构信息

Department of Orthopaedics, West China Hospital, Sichuan University, 37# WuhouGuoxue Road, Chengdu, China.

Department of Orthopaedics, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, China.

出版信息

BMC Musculoskelet Disord. 2021 May 28;22(1):492. doi: 10.1186/s12891-021-04377-4.

Abstract

BACKGROUND

Previous studies have demonstrated the efficacy of duloxetine in reducing postoperative pain and opioid consumption. However, the effect of duloxetine on total hip arthroplasty (THA) remains unclear. The objective of this study was to assess the efficacy of oral duloxetine in THA.

METHODS

We enrolled 96 patients in this randomized controlled trial. These patients were randomized (1,1) to either the duloxetine group or the placebo group and received daily doses of 60 mg duloxetine or placebo, respectively, from 2 d pre-operation to 14 d after surgery. The primary outcome was pain severity upon movement measured by a visual analogue scale (VAS). The secondary outcomes included VAS scores for resting pain, morphine consumption, Harris Hip Score, patient satisfaction at discharge, length of postoperative hospital stay, and adverse events.

RESULTS

Patients in the duloxetine group had significantly lower pain severity scores upon movement within 3 postoperative weeks (p < 0.05) while none of the differences met the minimum clinically important difference (MCID). Moreover, patients in the duloxetine group performed better in terms of resting pain (in 3 weeks after surgery), morphine requirements, and satisfaction level at discharge (all p < 0.05). There was no difference between groups in the prevalence of adverse events.

CONCLUSIONS

Although it did not result in a clinically meaning reduction in pain after total hip arthroplasty, perioperative administration of 60 mg of duloxetine daily significantly alleviated pain in the postoperative 3 weeks and morphine requirements during the postoperative 48 h. Therefore, duloxetine still shows promise in optimizing the multimodal pain-management protocols in total hip arthroplasty.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR2000033606 , 06/06/2020.

摘要

背景

先前的研究已经证明度洛西汀在减轻术后疼痛和减少阿片类药物消耗方面的疗效。然而,度洛西汀对全髋关节置换术(THA)的影响尚不清楚。本研究旨在评估口服度洛西汀在 THA 中的疗效。

方法

我们进行了这项随机对照试验,共纳入 96 例患者。这些患者按 1:1 随机分为度洛西汀组或安慰剂组,分别在术前 2 天至术后 14 天期间每天服用 60mg 度洛西汀或安慰剂。主要结局是通过视觉模拟评分(VAS)测量的运动时疼痛严重程度。次要结局包括静息疼痛的 VAS 评分、吗啡消耗量、Harris 髋关节评分、出院时患者满意度、术后住院时间和不良事件。

结果

在术后 3 周内,度洛西汀组患者的运动时疼痛严重程度评分显著降低(p<0.05),但无任何差异达到最小临床重要差异(MCID)。此外,度洛西汀组患者在静息疼痛(术后 3 周)、吗啡需求和出院时满意度方面表现更好(均 p<0.05)。两组间不良事件的发生率无差异。

结论

虽然术前口服度洛西汀 60mg 并未导致全髋关节置换术后疼痛的临床显著减轻,但它显著缓解了术后 3 周内的疼痛和术后 48 小时内的吗啡需求。因此,度洛西汀在优化全髋关节置换术的多模式疼痛管理方案方面仍有一定的应用前景。

试验注册

中国临床试验注册中心,ChiCTR2000033606,2020 年 6 月 6 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d2d/8161627/7681a8d4455b/12891_2021_4377_Fig1_HTML.jpg

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