Phase 3
N=5,521
Opioid Prescription After Cesarean Trial
Pregnancy Related · Opioid Use · Pain
Bottom Line
View on ClinicalTrials.gov: NCT04296396 ↗Enrolled (actual)
5,521
Serious AEs
2.6%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory — 1497; 1535 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0 to 20 tablets of oxycodone 5mg (Drug); Fixed opioid prescription (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- The George Washington University Biostatistics Center
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory |
1497; 1535 | — |
| SECONDARY Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge |
200; 166 | 0.046 sig |
| SECONDARY Number of Opioid Prescriptions Filled |
601; 452; 1873; 2086; 163; 140 | <0.001 sig |
| SECONDARY Number of Opioid Tablets Unused Since Discharge |
2; 7 | <0.001 sig |
| SECONDARY Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge |
22.5; 37.5 | <0.001 sig |
| SECONDARY Worst Pain Severity Score at 2 Weeks Post Discharge |
2.0; 2.0 | 1.0 |
| SECONDARY Pain Interference Score ≥ 4 at 2 Weeks Post Discharge |
415; 427 | 0.52 |
| SECONDARY Number of Participants Who Indicated an Improved Global Impression of Change |
2436; 2436 | 0.15 |
| SECONDARY Infant Hospital Readmissions |
59; 63 | — |
| SECONDARY Maternal Depression Score ≥ 13 |
185; 191 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04296396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.