Prescription After CesareanTrial - (PACT) MFMU Supplement

项目总结

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.