Opioid Prescription After Cesarean Trial

Summary

Participation Requirements

Description

This is 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 ...

This is 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. The primary endpoint is the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain is defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women will be assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization will be stratified by site. Women will be followed through 90 days postpartum.

Tracking Information