Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research Net

George Washington University, Washington DC

Investigators

Linked publications & trials

Abstract

Cesarean deliveries are the most commonly performed surgical procedure in the United States. Opioids are almost 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 prescribed more tablets at discharge than needed. These often go unused, unguarded, and undisposed, providing an important reservoir of opioids contributing to the opioid crisis. The one-size-fits-all approach to pain management is clearly suboptimal. The consequence of overprescribing opioids for 1.2 million cesareans annually is 12.5 million unused tablets. In addition to over-prescribing, one small study reported that pain scores were actually higher among women who were prescribed opioids compared with those who were prescribed ibuprofen and acetaminophen. To improve post-cesarean opioid prescribing practices without compromising pain management, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network proposes an individualized, patient empowered approach for pain management and opioid prescription quantity as part of the HEAL Pain Management Effectiveness Research Network. In an attempt to accomplish this, we propose a non-inferiority randomized trial of 5,500 women with a cesarean delivery who will be randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of 5mg oxycodone. Enrolled women will have four study visits after discharge and be followed through 90 days postpartum.