Prescription After CesareanTrial - (PACT) MFMU Supplement

项目总结 剖腹产是美国最常见的大型外科手术。系统性 阿片类药物已被普遍用于剖宫产后的止痛管理，片剂的数量 开出的处方在提供者和机构之间差别很大。痛阈值和止痛药需求 不同患者的情况不同，研究表明，大多数女性至少会开出10张以上的处方 出院时片剂超过所需。120万例剖宫产患者过量使用阿片类药物的后果 每年有1250万片未使用的药片。这些不用的药片经常没有人看管，也不会被丢弃，因为 一个重要的阿片类药物储藏库，可能被误用、转移或意外摄入，导致 阿片类药物危机。一刀切的疼痛管理方法显然不是最优的。有些女性可能不会 甚至需要阿片类药物：一项小型研究报告称，服用阿片类药物的女性疼痛评分更高 阿片类药物比那些开布洛芬和对乙酰氨基酚处方的人更多。虽然最近的研究评估了 在阿片类药物处方实践中，关于使用个性化阿片类药物处方的效果的数据有限 剖腹产后的协议。 尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所母胎 医疗单位(MFMU)网络提出了一项非劣势多中心5500人的随机试验 接受剖腹产的妇女在出院前被随机分为两组，一组服用个性化的阿片类药物 处方协议(IoPP)，包括共享决策或20片的固定阿片类药物处方 羟考酮5毫克，接近参与机构目前的护理标准。初级阶段 目的是评估共享决策的IoPP是否不逊于20%的固定阿片类药物处方 羟考酮5毫克片剂在疼痛治疗中的定义为有/没有中度至重度疼痛 出院后1周。次级AIMS将评估IoPP是否具有共享决策1) 减少阿片类药物补充处方，2)减少阿片类药物处方总量和总 使用的吗啡毫克当量，3)具有相同的疼痛强度和干扰，以及满足感 得分，以及4)减少不利的母婴结局。

PROJECT SUMMARY Cesarean delivery is the most commonly performed major surgical procedure in the United States. Systemic opioids have been universally used for post-cesarean analgesia management, with the number of tablets prescribed varying significantly between providers and institutions. Pain thresholds and analgesic requirements vary between patients, and studies suggest that most women are given prescriptions for at least 10 more tablets at discharge than needed. The consequence of over-prescribing opioids for 1.2 million cesareans annually is 12.5 million unused tablets. These unused tablets often go unguarded, and undisposed, providing an important reservoir of opioids that may be misused, diverted or accidentally ingested, contributing to the opioid crisis. The one-size-fits-all approach to pain management is clearly suboptimal. Some women may not even need opioids: one small study reported that pain scores were higher among women who were prescribed opioids than those who were prescribed ibuprofen and acetaminophen. While recent studies have evaluated opioid prescribing practices, there are limited data on the effect of using an individualized opioid prescription protocol following a cesarean delivery. The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal Fetal Medicine Units (MFMU) Network proposes a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who are randomized before discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision-making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg which approximates current standard of care at the participating institutions. The primary aim is to evaluate whether IOPP with shared decision-making is not inferior to a fixed opioid prescription of 20 tablets of oxycodone 5mg in pain management defined as the presence/absence of moderate to severe pain at 1 week after discharge. Secondary aims will evaluate whether IOPP with shared decision making 1) decreases an opioid refill prescription, 2) decreases the total amount of opioid tablets prescribed and the total morphine milligram equivalents used, 3) has equivalent pain intensity and interference, and satisfactions scores, and 4) reduces adverse maternal and infant outcomes.