Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized controlled trial involving 170 opioid naive women ages 19-40 undergoing scheduled C-sections at Carilion Roanoke Memorial Hospital. Participants are randomized to receive either 10 or 20 tabs of oxycodone 5mg as an initial postoperative prescription in a double-blinded parallel trial design. Outcome metrics related to overall opioid consumption and patient satisfaction with pain management are collected at three different time points post-operative: 2-3 days (in hospital), 10-14 days, and 6 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Carilion Clinic
• Collaborator: Virginia Polytechnic Institute and State University
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Female

• Age 19-40 years old

• Pregnant

• Scheduled to undergo cesarean section at Carilion Roanoke Memorial Hospital

• opioid naïve (defined as no opioid use within 30 days of surgery

Exclusion Criteria:

• History of chronic pain

• History of opioid use disorder

• History of any known intolerance or allergies to analgesics

• Women with postoperative complications (hysterectomy during or after birth, bowel or bladder injury during birth, need for re-operation, or immediate wound complication)

• Language barrier preventing screening or consent