NCT04296396

Opioid Prescription After Cesarean Trial

Prescription After Cesarean Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,521 (actual)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Non-inferiority randomized trial of 5,500 women with a cesarean delivery 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 oxycodone 5mg.

Detailed description

This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were 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 was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was 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 were 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 was stratified by site. Women were followed through 90 days postpartum.

Conditions

• Pregnancy Related
• Opioid Use
• Pain

Interventions

Type	Name	Description
DRUG	0 to 20 tablets of oxycodone 5mg	Individualized opioid prescription protocol (IOPP) that includes shared decision making
DRUG	Fixed opioid prescription	20 tablets of oxycodone 5mg

Timeline

• Start date: 2020-09-21
• Primary completion: 2022-04-07
• Completion: 2022-07-08
• First posted: 2020-03-05
• Last updated: 2023-10-03
• Results posted: 2023-10-03

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study