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全膝关节置换术中腘动脉与膝关节囊间隙浸润的疗效与安全性:一项前瞻性随机试验方案

The efficacy and safety of the infiltration of the interspace between the popliteal artery and the capsule of the knee block in total knee arthroplasty: A prospective randomized trial protocol.

作者信息

Cong Zhongxiao, Zhang Lejun, Ma Fengying

机构信息

Department of Operating Room, Qilu Hospital of Shandong University, Shandong, China.

出版信息

Medicine (Baltimore). 2020 Aug 14;99(33):e21670. doi: 10.1097/MD.0000000000021670.

Abstract

BACKGROUND

Total knee arthroplasty (TKA) is an established and successful surgical procedure which is the major treatment for degenerative knee joint diseases. A novel technique to address posterior knee joint pain is the infiltration of local anesthetic between the interspace between the popliteal artery and capsule of the knee (IPACK). The goal of this randomized clinical trial was to assess the efficacy and safety of adding IPACK to adductor canal block (ACB) after TKA.

METHODS

This was a prospectively randomized trial that investigated the effectiveness and safety of the IPACK after TKA. Approval from Clinical Studies Ethical Committee in Qilu Hospital of Shandong University was obtained. The inclusion criteria were adult patients undergoing primary unilateral TKA and American Society of Anesthesiologists grade 1 or 2 with normal cognitive function. The patients were randomized to 1 of 2 treatment options: ACB-alone group and ACB + IPACK group. The primary outcome was the total morphine consumption during postoperative 24 hours. Secondary outcomes included postoperative pain score, time to first and total dosage of rescue morphine in postoperative 48 hours, early and late postoperative period (from postoperative day 0-3 months follow-up) performance-based test (Timed-Up and Go test, and quadriceps strength). Postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and other adverse events were also evaluated.

RESULTS

It was hypothesized that when combined with a control group, the IPACK block would result in a lower morphine consumption and pain score after TKA.

TRIAL REGISTRATION

This study protocol was registered in Research Registry (researchregistry5765).

摘要

背景

全膝关节置换术(TKA)是一种成熟且成功的外科手术,是退行性膝关节疾病的主要治疗方法。一种解决膝关节后方疼痛的新技术是在腘动脉与膝关节囊间隙(IPACK)之间注射局部麻醉剂。这项随机临床试验的目的是评估TKA术后在收肌管阻滞(ACB)基础上加用IPACK的有效性和安全性。

方法

这是一项前瞻性随机试验,研究TKA术后IPACK的有效性和安全性。获得了山东大学齐鲁医院临床研究伦理委员会的批准。纳入标准为接受初次单侧TKA的成年患者,美国麻醉医师协会分级为1或2级,认知功能正常。患者被随机分为2种治疗方案中的1种:单纯ACB组和ACB + IPACK组。主要结局是术后24小时内吗啡的总消耗量。次要结局包括术后疼痛评分、术后48小时内首次及吗啡总用量的时间、术后早期和晚期(术后0天至3个月随访)基于表现的测试(计时起立行走测试和股四头肌力量)。还评估了术后恶心呕吐、住院时间、患者满意度及其他不良事件。

结果

假设与对照组相比,IPACK阻滞在TKA术后会导致更低的吗啡消耗量和疼痛评分。

试验注册

本研究方案已在研究注册库(researchregistry5765)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e9d/7437726/094ee3b92c8a/medi-99-e21670-g001.jpg

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