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术后低剂量度洛西汀对初次全膝关节置换术后的镇痛效果和吗啡消耗量的影响:一项前瞻性、双盲、随机对照试验。

Does postoperative low-dose duloxetine provide analgesic effect and lower morphine consumption after primary total knee arthroplasty? A prospective, double-blind, randomized controlled trial.

机构信息

Department of Orthopaedic Surgery, Thammasat University, Pathum Thani, Thailand.

Kasetsart University Laboratory School Center for Educational Research and Development, Bangkok, Thailand.

出版信息

Arch Orthop Trauma Surg. 2024 Nov;144(11):4979-4987. doi: 10.1007/s00402-024-05591-0. Epub 2024 Sep 30.

Abstract

INTRODUCTION

Duloxetine as an adjunct analgesic has shown effective results in trials of patients undergoing total knee arthroplasty (TKA). However, the regimen has not been standardized. We, therefore, evaluated the analgesic efficacy of low-dose duloxetine after TKA.

MATERIALS AND METHODS

We conducted a double-blind, randomized controlled trial of patients undergoing unilateral primary TKA, comparing 30 mg/d of duloxetine for 6 weeks as an additive medication for pain control to modern multimodal analgesia after TKA. The primary outcome measure was a visual analogue scale (VAS) for pain at rest, during walking, and at night at 24 h, 72 h, 2 weeks, 6 weeks, and 12 weeks after the operation. Secondary outcomes were morphine consumption, adverse events, and functional outcomes: Oxford Knee Score, Knee injury and Osteoarthritis Outcome Score (KOOS).

RESULTS

Mean VAS for pain at rest, during walking, and at night at 24 h, 72 h, 2 weeks, 6 weeks, and 12 weeks showed no significant differences between the two groups, except a significantly lower mean VAS at night at 2 weeks in the duloxetine group. Mean total morphine consumption (0-72 h) was 33% less in the duloxetine group (6.8 ± 5.7 vs. 10.2 ± 7.3 mg, p = 0.04). There were no significant differences in adverse events and functional outcomes except better KOOS symptoms at 6 and 12 weeks in the duloxetine group.

CONCLUSION

Low-dose duloxetine could reduce postoperative morphine consumption and improve KOOS symptoms at 6 and 12 weeks with good tolerability. However, it did not significantly reduce pain at rest or during walking. Low-dose duloxetine can be considered an addition to contemporary multimodal pain management after TKA.

LEVEL OF EVIDENCE V

Therapeutic Level I.

摘要

介绍

度洛西汀作为一种辅助镇痛剂,在全膝关节置换术(TKA)患者的试验中显示出了有效的结果。然而,该方案尚未标准化。因此,我们评估了 TKA 后低剂量度洛西汀的镇痛效果。

材料与方法

我们进行了一项双盲、随机对照试验,纳入了接受单侧初次 TKA 的患者,比较了 TKA 后使用度洛西汀 30mg/d 作为辅助药物控制疼痛与现代多模式镇痛的效果。主要观察指标为术后 24h、72h、2 周、6 周和 12 周时静息、行走和夜间的视觉模拟评分(VAS)。次要结局指标为吗啡消耗量、不良反应和功能结局:牛津膝关节评分(Oxford Knee Score,OKS)、膝关节损伤和骨关节炎结果评分(Knee injury and Osteoarthritis Outcome Score,KOOS)。

结果

两组患者在静息、行走和夜间 VAS 评分(24h、72h、2 周、6 周和 12 周)方面无显著差异,仅在度洛西汀组 2 周时夜间 VAS 评分显著降低。度洛西汀组的吗啡总消耗量(0-72h)减少了 33%(6.8±5.7mg 比 10.2±7.3mg,p=0.04)。除了度洛西汀组在 6 周和 12 周时 KOOS 症状更好外,两组在不良反应和功能结局方面无显著差异。

结论

低剂量度洛西汀可减少术后吗啡消耗量,并在 6 周和 12 周时改善 KOOS 症状,且具有良好的耐受性。然而,它并未显著减轻静息或行走时的疼痛。低剂量度洛西汀可作为 TKA 后现代多模式疼痛管理的辅助手段。

证据水平

治疗性研究,等级 V。

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