髋臼周围截骨术后早期恢复：48 毫克与 8 毫克地塞米松的双盲、随机、单中心试验。

Early postoperative recovery after peri-acetabular osteotomy: A double-blind, randomised single-centre trial of 48 vs. 8 mg dexamethasone.

机构信息

From the Department of Anaesthesiology, Centre for Cancer and Organ Diseases (KJS, HNA, EKA), the Surgical Pathophysiology Unit (KJS, HK), the Department of Anaesthesiology, Centre of Head and Orthopaedics (JD), the Department of Orthopaedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (JS, NSW).

出版信息

Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S41-S49. doi: 10.1097/EJA.0000000000001410.

DOI:10.1097/EJA.0000000000001410

PMID:33399374

Abstract

BACKGROUND

Peri-acetabular osteotomy is the joint-preserving treatment of choice in young adults with hip dysplasia but is associated with intense pain and high opioid consumption postoperatively.

OBJECTIVES

To investigate whether 48 mg of pre-operative dexamethasone was superior to a standard dose of 8 mg on reducing pain in the immediate postoperative phase.

DESIGN

A randomised, double-blind trial.

SETTING

Single-centre, primary facility. May 2017 to August 2019.

PATIENTS

At least 18 years undergoing peri-acetabular osteotomy.

INTERVENTIONS

Patients were randomised 1 : 1 to 48 or 8 mg dexamethasone intravenous (i.v.) as a single pre-operative injection. All patients received a standardised peri-operative protocol, including pre-operative acetaminophen and gabapentin, total i.v. anaesthesia and local anaesthetic catheter based wound administration.

MAIN OUTCOME MEASURE

Number of patients with moderate/severe pain [>3 on a numeric rating scale (NRS)] in the immediate postoperative phase.

RESULTS

Sixty-four patients (32 in each group) were included, and their data analysed. At some point from tracheal extubation until transfer to the ward, the NRS was more than 3 in 75% (24/32) of the 48 mg group and in 66% (21/32) in the 8 mg group, odds ratio 1.571 (95% CI, 0.552 to 4.64), P = 0.585. Patients in the 48 mg group received less opioid [cumulative rescue analgesics, oral morphine equivalents (OMEQ)] during postoperative days 0-4: median [IQR] OMEQ was 36 [15 to 85] mg vs. 79 [36 to 154] mg in the 48 and 8 mg group, respectively, P = 0.034. There were no statistically significant differences regarding complications, rate of infections or readmissions.

CONCLUSION

Forty-eight milligram of dexamethasone did not reduce pain in the immediate postoperative phase compared with an 8 mg dose. We observed insignificantly lower pain scores and significantly lower cumulated opioid requirements in the 48 mg group during the first four postoperative days.

TRIAL REGISTRATION

Clinicaltrials.gov, NCT03161938, EudraCT (2017-000544-1).

摘要

背景

髋臼周围截骨术是年轻髋关节发育不良患者首选的保关节治疗方法，但术后疼痛剧烈，阿片类药物消耗量大。

目的

研究术前使用 48mg 地塞米松是否优于标准剂量 8mg 地塞米松，以减少术后即刻的疼痛。

设计

随机、双盲试验。

地点

单中心，初级医疗机构。2017 年 5 月至 2019 年 8 月。

患者

至少 18 岁，行髋臼周围截骨术。

干预措施

患者按 1：1 随机分为 48mg 或 8mg 地塞米松静脉（i.v.）单次术前注射组。所有患者均接受标准化围手术期方案，包括术前对乙酰氨基酚和加巴喷丁、全静脉麻醉和局部麻醉导管伤口给药。

主要观察指标

术后即刻有中度/重度疼痛（NRS>3）的患者人数。

结果

共纳入 64 例患者（每组 32 例），并对其数据进行了分析。在气管拔管至转至病房的某个时间点，48mg 组中 75%（24/32）的患者和 8mg 组中 66%（21/32）的患者的 NRS 评分大于 3，比值比为 1.571（95%CI，0.552 至 4.64），P=0.585。48mg 组患者在术后第 0-4 天接受的阿片类药物（口服吗啡等效剂量（OMEQ））更少：中位数[IQR]OMEQ 分别为 36[15 至 85]mg 和 79[36 至 154]mg，48mg 和 8mg 组，P=0.034。两组在并发症、感染率或再入院率方面无统计学差异。