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脂质体布比卡因腹横肌平面阻滞与硬膜外镇痛在结直肠手术加速康复路径中的比较:一项随机临床试验。

Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial.

机构信息

Department of Surgery, St Joseph Mercy Hospital, Ann Arbor, Michigan.

Department of Academic Research, St Joseph Mercy Hospital, Ann Arbor, Michigan.

出版信息

Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.

Abstract

BACKGROUND

Multimodal pain management is an integral part of enhanced recovery pathways. The most effective pain management strategies have not been determined.

OBJECTIVE

The purpose of this study was to compare liposomal bupivacaine transversus abdominis plane block with epidural analgesia in patients undergoing colorectal surgery.

DESIGN

This is a single-institution, open-label randomized (1:1) trial.

SETTING

This study compared liposomal bupivacaine transversus abdominis plane block with epidural analgesia in patients undergoing elective open and minimally invasive colorectal surgery in an enhanced recovery pathway.

PATIENTS

Two hundred were enrolled. Following randomization, allocation, and follow-up, there were 92 patients with transversus abdominis plane block and 87 patients with epidural analgesia available for analysis.

INTERVENTIONS

The interventions comprised liposomal bupivacaine transversus abdominis plane block versus epidural analgesia.

MAIN OUTCOME MEASURES

The primary outcomes measured were numeric pain scores and the overall benefit of analgesia scores.

RESULTS

There were no significant differences in the Numeric Pain Scale and Overall Benefit of Analgesia Score between groups. Time trend analysis revealed that patients with transversus abdominis plane block had higher numeric pain scores on the day of surgery, but that the relationship was reversed later in the postoperative period. Opioid use was significantly less in the transversus abdominis plane block group (206.84 mg vs 98.29 mg, p < 0.001). There were no significant differences in time to GI recovery, hospital length of stay, and postoperative complications. Cost was considerably more for the epidural analgesia group.

LIMITATIONS

This study was conducted at a single institution.

CONCLUSIONS

This randomized trial shows that perioperative pain management with liposomal bupivacaine transversus abdominis plane block is as effective as epidural analgesia and is associated with less opioid use and less cost. These data and the more favorable risk profile suggest that liposomal bupivacaine transversus abdominis plane block is a viable multimodal perioperative pain management option for this patient population in an established enhanced recovery pathway.

CLINICAL TRIAL REGISTRATION

http://www.clinicaltrials.gov (NCT02591407). See Video Abstract at http://links.lww.com/DCR/A737.

摘要

背景

多模式疼痛管理是加速康复途径的重要组成部分。尚未确定最有效的疼痛管理策略。

目的

本研究旨在比较罗哌卡因腹横肌平面阻滞与硬膜外镇痛在结直肠手术患者中的效果。

设计

这是一项单中心、开放标签、随机(1:1)试验。

地点

本研究比较了罗哌卡因腹横肌平面阻滞与硬膜外镇痛在加速康复途径下择期开腹和微创结直肠手术患者中的效果。

患者

共纳入 200 例患者。随机分组、分配和随访后,92 例患者接受腹横肌平面阻滞,87 例患者接受硬膜外镇痛,可供分析。

干预措施

干预措施包括罗哌卡因腹横肌平面阻滞与硬膜外镇痛。

主要结局测量指标

主要结局测量指标为数字疼痛评分和镇痛总获益评分。

结果

两组间数字疼痛评分和镇痛总获益评分无显著差异。时间趋势分析显示,腹横肌平面阻滞组患者在手术当天的数字疼痛评分较高,但在术后后期,这种关系发生了逆转。腹横肌平面阻滞组阿片类药物用量显著减少(206.84mg 比 98.29mg,p<0.001)。胃肠恢复时间、住院时间和术后并发症无显著差异。硬膜外镇痛组的成本明显更高。

局限性

本研究仅在一家机构进行。

结论

本随机试验表明,罗哌卡因腹横肌平面阻滞用于围手术期疼痛管理与硬膜外镇痛同样有效,且阿片类药物用量更少,成本更低。这些数据和更有利的风险特征表明,罗哌卡因腹横肌平面阻滞是该患者人群在既定加速康复途径下多模式围手术期疼痛管理的可行选择。

临床试验注册

http://www.clinicaltrials.gov(NCT02591407)。详见视频摘要,网址:http://links.lww.com/DCR/A737。

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