PACT: Opioid Prescription After Cesarean Trial
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Individualized Opioid Prescription Individualized opioid prescription protocol and shared decision making |
Drug: 0 to 20 tablets of oxycodone 5mg
Individualized opioid prescription protocol (IOPP) that includes shared decision making
|
| Other: Fixed Opioid Prescription fixed opioid prescription of 20 tablets of oxycodone 5mg |
Drug: Fixed opioid prescription
20 tablets of oxycodone 5mg
|
Outcome Measures
Primary Outcome Measures
- Moderate to Severe Worst Pain Score at 1 week post discharge [1 week post hospital discharge]
Proportion of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the Brief Pain Inventory worst pain in the last 24 hours numeric scale (from 0 to 10)
Secondary Outcome Measures
- Opioid prescription filled beyond that prescribed at discharge [2 weeks post discharge, 6 weeks postpartum, and 90 days postpartum]
Proportion of participants with opioid prescription filled (beyond that prescribed at discharge) between one week post discharge and 1) two weeks post-discharge, 2) six weeks postpartum, and 3) ninety days postpartum
- Number of opioid prescriptions filled [1week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum]
Total number of opioid prescriptions filled by one and two weeks post-discharge, and six weeks and ninety days postpartum
- Number of opioid tablets prescribed and unused [1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum]
Number of opioid tablets prescribed and unused from discharge to 1 week and 2 weeks post discharge, and 6 weeks and 90 days postpartum
- Number of morphine milligram equivalents used [1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum]
Total morphine milligram equivalents (MME) used from discharge to 1 week and 2 weeks post-discharge, and 6 weeks and 90 days postpartum
- Pain severity scores (worst, least, average, current) [2 weeks post discharge and 6 weeks postpartum and 90 days postpartum]
Pain severity scores (worst, least, average, current) in last 24 hours assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge, and 6 weeks and 90 days postpartum
- Pain interference scores [1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum]
Pain interference scores in the last week assessed on the Brief Pain Inventory (numeric scale from 0 to 10) at 1 and 2 weeks post-discharge, and 6 weeks and 90 days postpartum
- Global impression of change in overall pain [1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum]
Proportion of participants with global impression of change in overall pain (improved, no change, worse) at 1 and 2 weeks post-discharge, and 6 weeks and 90 days postpartum
- Infant hospital readmissions [6 weeks postpartum]
Proportion of infants readmitted to the hospital
- Maternal postpartum weight retention [6 weeks postpartum]
- Maternal depression score ≥ 13 [6 weeks postpartum]
The proportion of participants with a score of 13 or higher on the Edinburgh Postnatal Depression Scale. The minimum score is 0 and the maximum score is 30. Higher scores indicate worse outcomes, where persons scoring about 13 are likely to be suffering from a depressive illness. The scale indicates how the respondent has felt during the previous week.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama - Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 3 | Columbia University | New York | New York | United States | 10032 |
| 4 | University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | United States | 17599 |
| 5 | Case Western Reserve-Metrohealth | Cleveland | Ohio | United States | 44109 |
| 6 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 7 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 8 | Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
| 9 | Brown Univeristy | Providence | Rhode Island | United States | 02905 |
| 10 | University of Texas Medical Branch | Galveston | Texas | United States | 77555 |
| 11 | University of Texas - Houston | Houston | Texas | United States | 77030 |
| 12 | University of Utah Medical Center | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- The George Washington University Biostatistics Center
Investigators
- Study Director: Monica Longo, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HD036801-PACT