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高剂量地塞米松对髋臼周围截骨术治疗髋关节发育不良后吗啡使用的影响:一项随机双盲安慰剂对照单中心试验。

Effect of high-dose dexamethasone on morphine use after periacetabular osteotomy for hip dysplasia: a randomized double-blind placebo-controlled single center trial.

作者信息

Lindberg-Larsen Viktoria, Lindberg-Larsen Martin, Ovesen Ole, Zwisler Stine T, Lindholm Peter, Hebsgaard Stine, Christensen Robin, Overgaard Søren

机构信息

Department of Anesthesiology and Intensive Care Medicine, Odense University Hospital, Odense; Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense; Orthopaedic Research Unit, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.

出版信息

Acta Orthop. 2025 Jun 1;96:413-420. doi: 10.2340/17453674.2025.43903.

DOI:10.2340/17453674.2025.43903
PMID:40460271
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12128623/
Abstract

BACKGROUND AND PURPOSE

Periacetabular osteotomy (PAO) for hip dysplasia is associated with intensive pain and high opioid consumption. High doses of dexamethasone may reduce this. We aimed to compare the effect of 1 or 2 doses of dexamethasone 24 mg, relative to placebo, on postoperative morphine consumption after PAO.

METHODS

A 3-group, randomized, double-blind, placebo-controlled trial was undertaken on patients ≥ 18 years, undergoing PAO (ClinicalTrials.gov: NCT03874936). Randomization Group A received 1 preoperative dose of dexamethasone 24 mg and placebo 24 hours later; Group B received 1 dose of intravenous dexamethasone 24 mg preoperatively and a repeated dose 24 hours postoperatively; and Group C received placebo at both time points. The primary endpoint was the difference in least squares mean cumulative postoperative morphine consumption between the combined dexamethasone groups and placebo within 48 hours from baseline. Key secondary outcomes included postoperative pain intensity, nausea and vomiting, antiemetic consumption and Timed Up and Go at 24 and 48 hours postoperatively, and cumulative morphine consumption from 48 hours to day 14 post-operation.

RESULTS

90 patients were randomized to dexamethasone groups (n = 60) and placebo (n = 30); 58 and 28, respectively, completed the trial. Mean age was 31 years and 71 (79%) were females. In the combined dexamethasone group the mean cumulated postoperative morphine consumption within 48 hours was 92 mg vs 95 mg in the placebo group, corresponding to a between-group difference of -3 mg (95% confidence interval -27 to 21; P = 0.8). There were no differences observed between groups for any of the secondary outcomes.

CONCLUSION

High-dose dexamethasone did not reduce postoperative morphine use or improve any of the secondary outcomes after PAO.

摘要

背景与目的

髋臼周围截骨术(PAO)治疗髋关节发育不良会导致剧烈疼痛和大量使用阿片类药物。高剂量地塞米松可能会减少这种情况。我们旨在比较1或2剂24毫克地塞米松与安慰剂相比,对PAO术后吗啡用量的影响。

方法

对年龄≥18岁、接受PAO的患者进行了一项3组随机双盲安慰剂对照试验(ClinicalTrials.gov:NCT03874936)。随机分组:A组术前接受1剂24毫克地塞米松,24小时后接受安慰剂;B组术前接受1剂静脉注射24毫克地塞米松,术后24小时重复给药;C组在两个时间点均接受安慰剂。主要终点是从基线起48小时内,联合地塞米松组与安慰剂组术后最小二乘均数累积吗啡用量的差异。关键次要结局包括术后疼痛强度、恶心和呕吐、止吐药使用情况以及术后24小时和48小时的起立行走测试,以及术后48小时至第14天的累积吗啡用量。

结果

90例患者被随机分为地塞米松组(n = 60)和安慰剂组(n = 30);分别有58例和28例完成试验。平均年龄为31岁,71例(79%)为女性。联合地塞米松组术后48小时内的平均累积吗啡用量为92毫克,而安慰剂组为95毫克,组间差异为-3毫克(95%置信区间-27至21;P = 0.8)。在任何次要结局方面,各治疗组间均未观察到差异。

结论

高剂量地塞米松并未减少PAO术后的吗啡用量,也未改善任何次要结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cee/12128623/d4eca525fbb7/ActaO-96-43903-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cee/12128623/d4eca525fbb7/ActaO-96-43903-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cee/12128623/d4eca525fbb7/ActaO-96-43903-g001.jpg

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本文引用的文献

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Bernese periacetabular osteotomy (PAO): from its local inception to its worldwide adoption.伯尔尼髋臼周围截骨术(PAO):从局部起源到全球应用。
J Orthop Traumatol. 2023 Nov 2;24(1):55. doi: 10.1186/s10195-023-00734-2.
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Periacetabular Osteotomy for Symptomatic Acetabular Dysplasia in Patients ≥40 Years Old: Intermediate and Long-Term Outcomes and Predictors of Failure.髋臼周围截骨术治疗≥40 岁髋臼发育不良患者的症状:中期和长期结果及失败的预测因素。
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Guidelines for a structured manuscript: Statistical methods and reporting in biomedical research journals.结构化稿件指南:生物医学研究期刊中的统计方法与报告
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