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全膝关节置换术中鞘内注射吗啡或局部浸润麻醉后的围手术期镇痛:一项随机对照试验方案

Perioperative analgesia after intrathecal morphine or local infiltration anesthesia for total knee replacement: A protocol for randomized controlled trial.

作者信息

Qi Zhengrong, Guo Ai, Ma Lifeng, Li Zhiyao, Yang Bo, Zhang Jingxin

机构信息

Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

出版信息

Medicine (Baltimore). 2020 Sep 25;99(39):e22394. doi: 10.1097/MD.0000000000022394.

Abstract

OBJECTIVE

We perform this protocol for randomized controlled trial to compare the efficacy of intrathecal morphine and local infiltration anesthesia (LIA) in the treatment of the postoperative pain after total knee replacement (TKR).

METHODS

This is a randomized controlled, single center trial which was performed from March 2019 to March 2020. This trial is conducted according to the SPIRIT Checklist of randomized researches. It is authorized via the Ethics Committee of Beijing Friendship Hospital (2019-P2-050-01). Eighty participants who undergo TKR were randomized into 2 groups. Intrathecal morphine group: 0.1 mg of the morphine was intrathecally injected, and the spinal anesthetic was injected at the same time in the group LIA; In the LIA group: the knee joint was infiltrated with epinephrine, ketorologic acid and ropivacaine in the process of operation, and the identical mixture was injected 2 bolus through the intraarticular catheter after operation. The main outcome variables were the visual analog scale and the consumption amount of opioid every 6-hour interval within 2 days postoperatively. The secondary outcome variables were the side effects associated with opioid, the length of hospital stay, motion range, and the loss of blood collected by the closed suction drainage. All the required analyses were carried out via applying the SPSS for Windows Version 19.0.

RESULTS

The clinical outcome variables between groups were shown in .

CONCLUSION

This protocol will provide the evidence on which technique can achieve better analgesia after TKR.

摘要

目的

我们执行此随机对照试验方案,以比较鞘内注射吗啡与局部浸润麻醉(LIA)在全膝关节置换术(TKR)后治疗术后疼痛的疗效。

方法

这是一项于2019年3月至2020年3月进行的单中心随机对照试验。本试验按照随机研究的SPIRIT清单进行。该试验经北京友谊医院伦理委员会批准(2019-P2-050-01)。80例行TKR的参与者被随机分为2组。鞘内注射吗啡组:鞘内注射0.1毫克吗啡,LIA组同时注射脊髓麻醉剂;LIA组:术中膝关节用肾上腺素、酮咯酸和罗哌卡因浸润,术后通过关节内导管注射2次相同混合物。主要结局变量为术后2天内每6小时间隔的视觉模拟评分和阿片类药物消耗量。次要结局变量为与阿片类药物相关的副作用、住院时间、活动范围以及闭式吸引引流收集的失血量。所有所需分析均通过应用Windows版SPSS 19.0进行。

结果

组间临床结局变量见表。

结论

本方案将为TKR后哪种技术能实现更好的镇痛提供证据。

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