Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial.

IF 4.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY Obstetrics and gynecology Pub Date : 2024-08-01 Epub Date: 2024-06-10 DOI:10.1097/AOG.0000000000005649

Marcela C Smid, Rebecca G Clifton, Kara Rood, Sindhu Srinivas, Hyagriv N Simhan, Brian M Casey, Monica Longo, Ruth Landau, Cora MacPherson, Anna Bartholomew, Amber Sowles, Uma M Reddy, Dwight J Rouse, Jennifer L Bailit, John M Thorp, Suneet P Chauhan, George R Saade, William A Grobman, George A Macones

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Abstract

Objective: To test whether an individualized opioid-prescription protocol (IOPP) with a shared decision-making component can be used without compromising postcesarean pain management.

Methods: In this multicenter randomized controlled noninferiority trial, we compared IOPP with shared decision making with a fixed quantity of opioid tablets at hospital discharge. We recruited at 31 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Study participants had uncomplicated cesarean births. Follow-up occurred through 12 weeks postdischarge. Individuals with complicated cesarean births or history of opioid use in the pregnancy were excluded. Participants were randomized 1:1 to IOPP with shared decision making or fixed quantity (20 tablets of 5 mg oxycodone). In the IOPP group, we calculated recommended tablet quantity based on opioid use in the 24 hours before discharge. After an educational module and shared decision making, participants selected a quantity of discharge tablets (up to 20). The primary outcome was moderate to severe pain (score 4 or higher [possible range 0-10]) on the BPI (Brief Pain Inventory) at 1 week after discharge. A total sample size of 5,500 participants was planned to assess whether IOPP with shared decision making was not inferior to the fixed quantity of 20 tablets.

Results: From September 2020 to March 2022, 18,990 individuals were screened and 5,521 were enrolled (n=2,748 IOPP group, n=2,773 fixed-quantity group). For the primary outcome, IOPP with shared decision making was not inferior to fixed quantity (59.5% vs 60.1%, risk difference 0.67%; 95% CI, -2.03% to 3.37%, noninferiority margin -5.0) and resulted in significantly fewer tablets received (median 14 [interquartile range 4-20] vs 20, P <.001) through 90 days postpartum.

Conclusion: Compared with fixed quantity, IOPP with shared decision making was noninferior for outpatient postcesarean analgesia at 1 week postdischarge and resulted in fewer prescribed opioid tablets at discharge.

Clinical trial registration: ClinicalTrials.gov, NCT04296396.

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优化剖腹产后阿片类药物处方量：随机对照试验

目的检验是否可以在不影响剖宫产后疼痛管理的情况下使用包含共同决策内容的个体化阿片类药物处方方案（IOPP）：在这项多中心随机对照非劣效性试验中，我们比较了 IOPP 与共同决策以及出院时固定数量的阿片类药物片剂。我们在参与尤妮斯-肯尼迪-施莱佛国家儿童健康与人类发展研究所母胎医学单位网络的 31 个中心进行了招募。研究参与者均为无并发症剖宫产。随访至出院后 12 周。患有复杂性剖宫产或在妊娠期间有阿片类药物使用史的患者被排除在外。参与者按 1:1 随机分配到共同决策的 IOPP 或固定数量（20 片 5 毫克羟考酮）组。在 IOPP 组中，我们根据出院前 24 小时内阿片类药物的使用情况计算出推荐的药片数量。经过教育模块和共同决策后，参与者选择了出院药片的数量（最多 20 片）。主要结果是出院后 1 周的 BPI（简短疼痛量表）中度至重度疼痛（得分 4 分或以上[可能范围 0-10]）。计划的总样本量为 5,500 人，以评估共同决策的 IOPP 是否不逊于固定数量的 20 片：从 2020 年 9 月到 2022 年 3 月，共有 18,990 人接受了筛查，5,521 人入组（n=2,748 人 IOPP 组，n=2,773 人固定数量组）。就主要结果而言，采用共同决策的 IOPP 不逊于固定数量组（59.5% vs 60.1%，风险差异为 0.67%；95% CI，-2.03% 至 3.37%，非劣效边距为-5.0），但收到的药片数量显著减少（中位数为 14 片 [四分位间范围为 4-20] vs 20 片，PC 结论：与固定数量相比，共同决策的 IOPP 在出院后 1 周的门诊剖宫产术后镇痛效果不劣于固定数量，出院时处方阿片类药物的数量也更少：临床试验注册：ClinicalTrials.gov，NCT04296396。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Obstetrics and gynecology 医学-妇产科学

CiteScore

11.10

自引率

4.20%

发文量

867

审稿时长

1 months

期刊介绍： "Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics. "Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.