Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial.

IF 1.9 4区医学 Q2 ANESTHESIOLOGY

Acta Anaesthesiologica Scandinavica Pub Date : 2024-01-01 Epub Date: 2023-09-14 DOI:10.1111/aas.14319

Cecilie Bauer Derby, Kasper Smidt Gasbjerg, Daniel Hägi-Pedersen, Troels Haxholdt Lunn, Niels Anker Pedersen, Peter Lindholm, Stig Brorson, Henrik Morville Schrøder, Kasper Højgaard Thybo, Jens Bagger, Martin Lindberg-Larsen, Søren Overgaard, Janus Christian Jakobsen, Ole Mathiesen

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Abstract

Objectives: The DEX-2-TKA trial demonstrated that one and two doses of 24 mg intravenous dexamethasone reduced opioid consumption and pain after total knee arthroplasty (TKA). We aimed to investigate the prolonged effects of dexamethasone after the 48-h intervention period.

Design: This was a prospective, pre-planned questionnaire follow-up on postoperative days 3-7 of patients in the DEX-2-TKA trial that randomly received: DX1 (dexamethasone 24 mg + placebo), DX2 (dexamethasone 24 mg + dexamethasone 24 mg), and placebo (placebo + placebo) perioperatively and 24 h later.

Setting: A multicenter trial performed at five Danish hospitals.

Participants: We analyzed 434 of 485 adult participants enrolled in the DEX-2-TKA trial.

Outcome measures: Primary outcome was difference between groups in average of all numerical rating scale (NRS) pain scores reported in the morning, at bedtime, and the daily average pain on postoperative days 3-7. Secondary outcomes were sleep quality and patient satisfaction.

Results: The median (interquartile range) pain intensity levels for postoperative days 3-7 were: DX2 3.2 (2.1-4.3); DX1 3.3 (2.3-4.1); and placebo 3.3 (2.5-4.7). Hodges-Lehmann median differences between groups were: 0 (95% confidence interval - 0.54 to 0.2), P = 0.38 between DX1 and placebo; 0.1 (-0.47 to 0.33), p = .87 between DX1 and DX2; and 0.1 (-0.6 to 0.13), p = .20 between DX2 and placebo. We found no relevant differences between groups on sleep quality on postoperative days 3-7 nor for patient satisfaction with the analgesic treatment.

Conclusions: We found that neither one nor two doses of 24 mg intravenous dexamethasone demonstrated prolonged effects on overall pain or sleep quality on postoperative days 3-7 after total knee arthroplasty. We also found that dexamethasone had no effect on patient satisfaction.

Trial registration number: Clinicaltrials.gov NCT03506789 (main result trial).

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全膝关节置换术后地塞米松的长期作用：DEX-2-TKA 试验的一项预先计划的子研究。

目的：DEX-2-TKA试验表明，静脉注射一剂和两剂24毫克地塞米松可减少全膝关节置换术（TKA）后阿片类药物的用量和疼痛。我们旨在研究地塞米松在 48 小时干预期后的长期效果：设计：这是一项前瞻性的、预先计划好的问卷调查，在术后第3-7天对随机接受DEX-2-TKA试验的患者进行随访：DX1（地塞米松 24 毫克 + 安慰剂）、DX2（地塞米松 24 毫克 + 地塞米松 24 毫克）和安慰剂（安慰剂 + 安慰剂）：在丹麦五家医院进行的多中心试验：我们对参加 DEX-2-TKA 试验的 485 名成年参与者中的 434 人进行了分析：主要结果：各组患者在清晨、睡前和术后第 3-7 天的日平均疼痛报告中所有数字评分量表 (NRS) 疼痛评分的平均值的差异。次要结果为睡眠质量和患者满意度：术后第 3-7 天疼痛强度的中位数（四分位间距）为DX2为3.2（2.1-4.3）；DX1为3.3（2.3-4.1）；安慰剂为3.3（2.5-4.7）。组间霍奇斯-莱曼中位数差异为DX1和安慰剂之间为0（95%置信区间-0.54至0.2），P = 0.38；DX1和DX2之间为0.1（-0.47至0.33），P = 0.87；DX2和安慰剂之间为0.1（-0.6至0.13），P = 0.20。在术后第 3-7 天的睡眠质量和患者对镇痛治疗的满意度方面，我们没有发现组间存在相关差异：结论：我们发现，在全膝关节置换术后第 3-7 天，静脉注射一剂或两剂 24 毫克地塞米松都不会对总体疼痛或睡眠质量产生长期影响。我们还发现，地塞米松对患者满意度没有影响：试验注册号：Clinicaltrials.gov NCT03506789（主要结果试验）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta Anaesthesiologica Scandinavica 医学-麻醉学

CiteScore

4.30

自引率

9.50%

发文量

157

审稿时长

3-8 weeks

期刊介绍： Acta Anaesthesiologica Scandinavica publishes papers on original work in the fields of anaesthesiology, intensive care, pain, emergency medicine, and subjects related to their basic sciences, on condition that they are contributed exclusively to this Journal. Case reports and short communications may be considered for publication if of particular interest; also letters to the Editor, especially if related to already published material. The editorial board is free to discuss the publication of reviews on current topics, the choice of which, however, is the prerogative of the board. Every effort will be made by the Editors and selected experts to expedite a critical review of manuscripts in order to ensure rapid publication of papers of a high scientific standard.