Prescription After CesareanTrial - (PACT) MFMU Supplement

剖腹产试验后的处方 - (PACT) MFMU 补充

• 批准号: 10434255
• 负责人: Rebecca Gersnoviez Clifton
• 金额: $ 55万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10434255
• 关键词: Absence of pain sensation; Acetaminophen; Acute; Analgesics; Birth; Caring; Cesarean section; Cessation of life; Chronic; Client satisfaction; Clinical; Data; Dependence; Development; Face; Hospitalization; Hospitals; Ibuprofen; Individual; Ingestion; Institution; Lead; Life; Maternal Mortality; Maternal-Fetal Medicine Units Network; Morphine; National Institute of Child Health and Human Development; Non-Steroidal Anti-Inflammatory Agents; Operative Surgical Procedures; Opioid; Opioid Analgesics; Overdose; Oxycodone; Pain; Pain Threshold; Pain intensity; Pain interference; Pain management; Patients; Play; Postoperative Pain; Postoperative Period; Pregnancy Rate; Prescription opioid overdose; Process; Protocols documentation; Provider; Randomized; Regimen; Reporting; Role; Surgeon; Tablets; Testing; United States; Woman; adverse maternal outcomes; impression; improved; improved outcome; infant outcome; milligram; non-opioid analgesic; nonmedical use; opioid epidemic; opioid use; pain score; pandemic disease; postcesarean section; pregnancy associated death; prescription opioid; randomized trial; satisfaction; shared decision making; standard of care

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.

项目摘要 剖腹产是美国最常见的主要外科手术。系统性 阿片类药物已普遍用于剖宫产术后镇痛管理， 规定的供应商和机构之间差异很大。疼痛阈值和镇痛需求 不同的病人，研究表明，大多数妇女被给予处方至少10多个 出院时服用的片剂多于所需。对120万剖腹产者过度处方阿片类药物的后果 每年有1250万片未使用的药片。这些未使用的药片往往无人看管，也没有处理， 阿片类药物的重要储存库，可能被滥用、转移或意外摄入， 鸦片危机一刀切的疼痛管理方法显然是次优的。有些女人可能不会 甚至需要阿片类药物：一项小型研究报告称， 服用布洛芬和对乙酰氨基酚的人更少。虽然最近的研究评估了 阿片类药物处方实践，关于使用个体化阿片类药物处方的影响的数据有限 剖腹产后的协议。 Eunice Kennedy Shriver国家儿童健康和人类发展研究所 医学单位（MFMU）网络提出了一项非劣效性多中心非盲随机试验， 接受剖腹产的女性，出院前随机接受个体化阿片类药物 处方协议（IOPP），包括共同决策或20片的固定阿片类药物处方 羟考酮5 mg，接近参与机构的当前护理标准。主 目的是评估具有共同决策的IOPP是否不劣于20的固定阿片类药物处方 羟考酮5 mg片剂用于疼痛管理，定义为存在/不存在中度至重度疼痛， 出院后1周。次要目标将评估IOPP是否具有共同决策1） 减少阿片类药物补充处方，2）减少阿片类药物片剂处方总量和总 使用吗啡毫克当量，3）具有相同的疼痛强度和干扰， 分数，和4）减少不利的孕产妇和婴儿的结果。