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多模式疼痛管理用于剖宫产:一项双盲、安慰剂对照、随机临床试验。

Multimodal Pain Management for Cesarean Delivery: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial.

机构信息

Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.

Department of Anesthesia, The University of Texas Medical Branch, Galveston, Texas.

出版信息

Am J Perinatol. 2019 Sep;36(11):1097-1105. doi: 10.1055/s-0039-1681096. Epub 2019 Mar 1.

DOI:10.1055/s-0039-1681096
PMID:30822800
Abstract

OBJECTIVE

Our objective was to evaluate the efficacy of perioperative multimodal pain management in reducing opioid use after elective cesarean delivery (CD).

STUDY DESIGN

A single-center, double-blinded, placebo-controlled randomized trial of women undergoing elective CD. Participants were allocated 1:1 to receive the multimodal protocol or matching placebos. The multimodal protocol consisted of a preoperative dose of intravenous acetaminophen, preincision injection of subcutaneous bupivacaine, and intraoperative injection of intramuscular ketorolac. Primary outcome was total opioid intake at 48 hours postoperatively. Secondary outcomes were pain scores, time to first opioid intake, neonatal outcomes, and total outpatient opioid intake on postoperative day (POD) 7. Data were analyzed using parametric and nonparametric tests and quantile regression as appropriate.

RESULTS

A total of 242 women were screened with 120 randomized, 60 to the multimodal group and 60 to control group. There was no significant difference in the primary outcome of opioid use nor in the secondary outcomes. Smokers and patients with a history of drug use had higher median postoperative opiate use and earlier administration. On POD 7, only 40% of prescribed opioids had been used, and there was no difference between the groups.

CONCLUSION

This perioperative multimodal pain regimen did not reduce opioid use in 48 hours after CD. Patients who smoke or with a history of drug use required more opioids in the postoperative period. Providers significantly overprescribed opioids after CD.

摘要

目的

我们的目的是评估围手术期多模式疼痛管理在减少择期剖宫产(CD)后阿片类药物使用的效果。

研究设计

一项单中心、双盲、安慰剂对照随机试验,纳入行择期 CD 的女性。参与者以 1:1 的比例随机分配接受多模式方案或匹配安慰剂。多模式方案包括术前静脉注射对乙酰氨基酚、切口前皮下注射布比卡因和术中肌内注射酮咯酸。主要结局是术后 48 小时内的总阿片类药物摄入量。次要结局是疼痛评分、首次使用阿片类药物的时间、新生儿结局以及术后第 7 天的总门诊阿片类药物摄入量。数据采用参数和非参数检验以及适当的分位数回归进行分析。

结果

共筛选了 242 名女性,其中 120 名随机分组,60 名进入多模式组,60 名进入对照组。阿片类药物使用的主要结局和次要结局均无显著差异。吸烟者和有药物使用史的患者术后阿片类药物使用中位数较高,且用药时间更早。术后第 7 天,仅使用了处方阿片类药物的 40%,且两组之间无差异。

结论

这种围手术期多模式疼痛管理方案并不能减少 CD 后 48 小时内的阿片类药物使用。吸烟或有药物使用史的患者在术后期间需要更多的阿片类药物。CD 后,医生明显过度开具了阿片类药物。

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