Opioid Prescription After Cesarean Trial
Purpose
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.
Conditions
- Pregnancy Related
- Opioid Use
- Pain
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) - Singleton, twin or triplet gestation
Exclusion Criteria
- An opioid prescription filled during the current pregnancy - Known history of opioid use disorder, by medical record review - Contraindication to opioids (oxycodone) - Contraindications to both acetaminophen and ibuprofen - Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different - Fetal or neonatal death prior to randomization - Inability to randomize within 1 day before planned discharge from the hospital - Inability to participate in shared decision making as assessed by research staff - Language barrier (non-English or Spanish speaking) - Participation in this trial in a previous pregnancy - Participation in another intervention study that influences the primary outcome in this trial
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants were randomized 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.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Individualized Opioid Prescription |
Individualized opioid prescription protocol and shared decision making |
|
Other Fixed Opioid Prescription |
Fixed opioid prescription of 20 tablets of oxycodone 5mg |
|
More Details
- Status
- Completed
- Sponsor
- The George Washington University Biostatistics Center
Study Contact
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.