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在全髋关节置换术后,比较骼腹股沟筋膜和囊周神经群阻滞对术后疼痛和功能恢复的影响:一项非劣效性随机临床试验。

Comparison between supra-inguinal fascia iliaca and pericapsular nerve group blocks on postoperative pain and functional recovery after total hip arthroplasty: A noninferiority randomised clinical trial.

机构信息

From the Department of Anaesthesia and Intensive Care Medicine, Liege University Hospital (MC, FB, NP, J-PL, VLB), Inflammation and Enhanced Rehabilitation Laboratory (Regional Anaesthesia and Analgesia), GIGA-I3 Thematic Unit, GIGA-Research (MC, NP, J-PL), Anaesthesia and Perioperative Neuroscience Laboratory, GIGA-Consciousness Thematic Unit, GIGA-Research (FB, VLB) and Department of Physical Medicine, Rehabilitation and Sports Traumatology, Liege University Hospital, Liege, Belgium (SD).

出版信息

Eur J Anaesthesiol. 2023 Sep 1;40(9):660-671. doi: 10.1097/EJA.0000000000001875. Epub 2023 Jun 30.

Abstract

BACKGROUND

Pain after a posterolateral approach for total hip arthroplasty (THA) may affect early functional recovery. Supra-inguinal fascia iliaca (SFIB) and pericapsular nerve group (PENG) blocks have been proposed as promising analgesia techniques.

OBJECTIVES

This trial was conducted to compare a PENG with a SFIB for controlling postoperative pain and for providing functional recovery.

DESIGN

Noninferiority monocentric randomised controlled study.

SETTING

One hundred and two patients scheduled for a total hip arthroplasty via the posterolateral approach under spinal anaesthesia were prospectively allocated to two groups. Data acquisition occurred between October 2021 and July 2022 at the University Hospital of Liege.

PATIENTS

One hundred and two patients completed the trial.

INTERVENTIONS

Group SFIB received supra-inguinal fascia iliaca block (SFIB) (40 ml ropivacaine 0.375%), whereas group PENG received a PENG block (20 ml ropivacaine 0.75%).

MAIN OUTCOME MEASURES

Rest and mobilisation pain on a 0 to 10 numeric rating scale at fixed time points: 1 and 6 h after surgery, on day-1 and day-2 at 8 a.m.,1 p.m. and 6 p.m. On day-1 and day-2, evolution of quality-of-recovery-15 score was assessed, and timed-up-and-go, 2 and 6 min-walking tests. The noninferiority margin was set as 1 numeric rating scale point 6 h after surgery.

RESULTS

Six hours after surgery, pain scores in group PENG were noninferior to those of group SFIB, with a difference between medians at 0 (95% CI -0.93 to 0.93). There were no significant differences between the groups regarding rest and dynamic pain trajectories during the first 48 postoperative hours, with no significant effects of group (rest P  = 0.800; dynamic P  = 0.708) or interaction between group and time (rest P  = 0.803; dynamic P  = 0.187). Similarly, no significant differences were observed regarding motor and functional recovery as assessed by timed-up-and-go ( P  = 0.197), 2 min ( P  = 0.364), and 6 min walking ( P  = 0.347) tests and quality-of-recovery-15 ( P  = 0.417) score.

CONCLUSION

Following a total hip arthroplasty via the posterolateral approach, a PENG block is noninferior to SFIB regarding postoperative pain control 6 h after surgery, and functional recovery.

TRIAL REGISTRATION

European Clinical Trial Register under EudraCT-number 2020-005126-28 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005126-28/BE ).

摘要

背景

全髋关节置换术(THA)后路手术后的疼痛可能会影响早期功能恢复。髂筋膜上神经群(PENG)和囊周神经群(PENG)阻滞被认为是有前途的镇痛技术。

目的

本试验旨在比较 PENG 与 SFIB 对控制术后疼痛和促进功能恢复的效果。

设计

非劣效性单中心随机对照研究。

地点

102 例拟在椎管内麻醉下采用后路全髋关节置换术的患者前瞻性地分为两组。数据采集于 2021 年 10 月至 2022 年 7 月在列日大学医院进行。

患者

102 例患者完成了试验。

干预

SFIB 组接受髂筋膜上神经群阻滞(SFIB)(40ml 罗哌卡因 0.375%),而 PENG 组接受 PENG 阻滞(20ml 罗哌卡因 0.75%)。

主要观察指标

在固定时间点(术后 1 和 6 小时,第 1 天和第 2 天上午 8 点、下午 1 点和 6 点)用 0 到 10 的数字评分量表评估静息和活动时的疼痛:在第 1 天和第 2 天,评估质量恢复 15 分的变化,以及计时起立和走试验,2 分钟和 6 分钟步行试验。非劣效性边界设定为术后 6 小时 1 个数字评分量表点。

结果

术后 6 小时,PENG 组的疼痛评分与 SFIB 组相当,中位数差异为 0(95%CI -0.93 至 0.93)。在术后 48 小时内,两组的静息和动态疼痛轨迹均无显著差异,组间无显著影响(静息 P = 0.800;动态 P = 0.708)或组间交互作用(静息 P = 0.803;动态 P = 0.187)。同样,在计时起立和走试验(P = 0.197)、2 分钟(P = 0.364)和 6 分钟步行试验(P = 0.347)以及质量恢复 15 分(P = 0.417)评分方面,两组之间也没有观察到运动和功能恢复的显著差异。

结论

在全髋关节置换术采用后路入路后,PENG 阻滞在术后 6 小时的术后疼痛控制和功能恢复方面与 SFIB 相比不劣效。

试验注册

欧洲临床试验注册中心,注册号 EudraCT-number 2020-005126-28(https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005126-28/BE)。

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