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高剂量地塞米松用于全髋关节置换术高疼痛反应者:一项随机对照试验。

High dose dexamethasone in high pain responders undergoing total hip arthroplasty: A randomized controlled trial.

作者信息

Nielsen Niklas I, Kehlet Henrik, Gromov Kirill, Troelsen Anders, Husted Henrik, Varnum Claus, Kjærsgaard-Andersen Per, Rasmussen Lasse E, Pleckaitiene Lina, Foss Nicolai B

机构信息

From the Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark (NIN, NBF), Section of Surgical Pathophysiology, University of Copenhagen, Blegdamsvej 9, Denmark (HK), Department of Orthopaedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark (KG, AT, HH), Department of Orthopaedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark (CV, PK-A, LER), Department of Anaesthesiology, Lillebaelt Hospital - Vejle, Vejle, Denmark (LP).

出版信息

Eur J Anaesthesiol. 2023 Oct 1;40(10):737-746. doi: 10.1097/EJA.0000000000001853. Epub 2023 May 11.

DOI:10.1097/EJA.0000000000001853
PMID:37166257
Abstract

BACKGROUND

Postoperative pain after total hip arthroplasty (THA) may delay postoperative mobilization and discharge. Postoperative pain has been shown to be higher in pain catastrophisers and patients receiving opioids. A single dose of glucocorticoid reduces pain after THA, and an increased dose of glucocorticoids has been found to be effective in patients at high risk of postoperative pain after total knee arthroplasty (TKA), however, the ideal dose in THA remains unknown.

OBJECTIVE

To evaluate the effect of a high dose (1 mg kg -1 ) vs. intermediate dose (0.3 mg kg -1 ) of dexamethasone on pain after THA.

DESIGN

A randomized double-blind controlled study.

SETTING

A two-centre study including two large arthroplasty sites in Denmark was conducted from February 2019 to August 2020.

PATIENTS

A total of 160 patients undergoing THA by neuraxial block with multimodal analgesia, having a Pain Catastrophising Scale score >20 and/or preoperative opioid use were included.

INTERVENTION

Patients were randomly assigned to receive dexamethasone 1 mg kg -1 or 0.3 mg kg -1 before THA.

MAIN OUTCOME MEASURES

Primary outcome was percentage of patients experiencing moderate to severe pain (visual analogue scale, VAS > 30 mm on a 0 to 100 mm scale) on ambulating 24 h after surgery. Secondary outcomes included cumulated pain scores, C-reactive protein (CRP), opioid use, postoperative recovery scores, length of stay, complications, and re-admission within 30 and 90 days.

RESULTS

No difference was found in percentage of VAS >30 mm 24 h after surgery in the 5-m walk test (VAS > 30/VAS ≤ 30%); 33/42 (44%) vs. 32/43 (43%), relative risk = 1.04 (95% confidence interval 0.72-1.51; P  = 0.814) in 1 mg kg -1vs. 0.3 mg kg -1 respectively. No differences were found in CRP and opioid use between groups. Also, no intergroup differences were found in recovery scores, re-admissions, or complications.

CONCLUSION

1 mg kg -1vs. 0.3 mg kg -1 dexamethasone improved neither postoperative pain nor recovery in THA in a cohort of predicted high pain responders.

TRIAL REGISTRATION

ClinicalTrials.gov ID-number NCT03763760 and EudraCT-number 2018-2636-25.

摘要

背景

全髋关节置换术(THA)后的术后疼痛可能会延迟术后活动和出院。研究表明,疼痛灾难化者和接受阿片类药物治疗的患者术后疼痛程度更高。单剂量糖皮质激素可减轻THA后的疼痛,并且已发现增加糖皮质激素剂量对全膝关节置换术(TKA)后有术后疼痛高风险的患者有效,然而,THA中的理想剂量仍不清楚。

目的

评估高剂量(1mg/kg-1)与中等剂量(0.3mg/kg-1)地塞米松对THA后疼痛的影响。

设计

一项随机双盲对照研究。

地点

2019年2月至2020年8月在丹麦的两个大型关节置换术中心进行了一项两中心研究。

患者

总共纳入160例接受神经轴阻滞联合多模式镇痛的THA患者,其疼痛灾难化量表评分>20且/或术前使用阿片类药物。

干预

患者在THA前被随机分配接受1mg/kg-1或0.3mg/kg-1的地塞米松。

主要观察指标

主要结局是术后24小时行走时经历中度至重度疼痛(视觉模拟量表,VAS在0至100mm量表上>30mm)的患者百分比。次要结局包括累积疼痛评分、C反应蛋白(CRP)、阿片类药物使用、术后恢复评分、住院时间、并发症以及30天和90天内的再次入院情况。

结果

在5米步行试验中,术后24小时VAS>30mm的百分比无差异(VAS>30/VAS≤30%);1mg/kg-1组为33/42(44%),0.3mg/kg-1组为32/43(43%),相对风险=1.04(95%置信区间0.72-1.51;P=0.814)。两组之间的CRP和阿片类药物使用无差异。此外,在恢复评分、再次入院或并发症方面也未发现组间差异。

结论

在一组预计疼痛反应较高的患者中,1mg/kg-1与0.3mg/kg-1的地塞米松均未改善THA后的术后疼痛或恢复情况。

试验注册

ClinicalTrials.gov标识符NCT03763760和EudraCT编号2018-2636-25。

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