罗哌卡因和酮咯酸用于剖宫产术后镇痛的伤口灌洗：一项随机对照试验。

Ropivacaine and Ketorolac Wound Infusion for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial.

机构信息

Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina; the Anesthesia Medical Group, Inc., Nashville, Tennessee; and the Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.

出版信息

Obstet Gynecol. 2020 Feb;135(2):427-435. doi: 10.1097/AOG.0000000000003601.

DOI:10.1097/AOG.0000000000003601

PMID:31923061

Abstract

OBJECTIVE

To evaluate the efficacy of wound infusion with ropivacaine plus ketorolac compared with placebo for post-cesarean delivery analgesia in women who received a multimodal analgesic regimen including intrathecal morphine.

METHODS

In a randomized double-blind study, women undergoing scheduled cesarean delivery under spinal or combined spinal epidural anesthesia were randomized to wound infusion with ropivacaine 0.2% plus ketorolac, or saline placebo using an elastometric pump for 48 hours. The primary outcome was pain score with movement at 24 hours after surgery (0-10 scale, 0=no pain and 10=worst possible pain). Secondary outcomes included pain scores at rest at 24 hours, pain scores at rest and with movement at 2 and 48 hours, opioid consumption, and time to first rescue analgesic. A sample size of 35 per group (n=70) was planned.

RESULTS

From November 8, 2016, to May 17, 2019, 247 women were screened, and 71 completed the study per protocol: 38 in the placebo group and 33 in the ropivacaine plus ketorolac group. Patient demographics and intraoperative characteristics were comparable between the groups. There was no significant difference between the groups in the primary outcome of pain score with movement at 24 hours (difference in median score 0, 95% CI -1 to 2, P=.94). There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16).

CONCLUSION

There was no benefit of wound infusion with ropivacaine and ketorolac in women who received intrathecal morphine and a multimodal analgesic regimen.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT02829944.

FUNDING SOURCE

The study was supported in part by Avanos Medical Inc.

摘要

目的

评估罗哌卡因联合酮咯酸用于接受鞘内吗啡的多模式镇痛方案的剖宫产术后镇痛的疗效。

方法

在一项随机双盲研究中，接受脊髓或腰硬联合麻醉下择期剖宫产的女性被随机分为两组，分别接受罗哌卡因 0.2%联合酮咯酸或生理盐水安慰剂的伤口输注，使用弹性泵输注 48 小时。主要结局为术后 24 小时运动时的疼痛评分（0-10 分，0 分无疼痛，10 分疼痛最严重）。次要结局包括术后 24 小时静息时的疼痛评分、术后 2 小时和 48 小时静息和运动时的疼痛评分、阿片类药物的消耗以及首次解救镇痛的时间。计划每组纳入 35 例（n=70）。

结果

从 2016 年 11 月 8 日至 2019 年 5 月 17 日，共筛选了 247 名女性，71 名女性按方案完成了研究：安慰剂组 38 名，罗哌卡因联合酮咯酸组 33 名。两组患者的人口统计学和术中特征无显著差异。在术后 24 小时运动时的疼痛评分这一主要结局方面，两组之间没有显著差异（中位数差值 0，95%CI-1 至 2，P=.94）。在其他时间点的疼痛评分、总阿片类药物消耗量（中位数消耗量差值-12.5mg，95%CI-30 至 5，P=.11）或解救镇痛的时间（中位数[四分位数范围]660[9-1496]与 954[244-1710]分钟，风险比 0.69，95%CI 0.41 至 1.17，P=.16）方面，安慰剂组和罗哌卡因联合酮咯酸组之间也没有显著差异。