Pain Clinical Trial
— PACTOfficial title:
Prescription After Cesarean Trial
Verified date | September 2023 |
Source | The George Washington University Biostatistics Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5521 |
Est. completion date | July 8, 2022 |
Est. primary completion date | April 7, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama - Birmingham | Birmingham | Alabama |
United States | University of North Carolina-Chapel Hill | Chapel Hill | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Case Western Reserve-Metrohealth | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | University of Texas - Houston | Houston | Texas |
United States | Columbia University | New York | New York |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
United States | Brown Univeristy | Providence | Rhode Island |
United States | University of Utah Medical Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
The George Washington University Biostatistics Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | Number 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 "Worst Pain" question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. | 1 week post hospital discharge | |
Secondary | Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge | Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum | After hospital discharge and up to 90 days postpartum | |
Secondary | Number of Opioid Prescriptions Filled | Number of opioid prescriptions filled by ninety days postpartum | 90 days postpartum | |
Secondary | Number of Opioid Tablets Unused Since Discharge | Number of opioid tablets unused from discharge to 90 days postpartum | 90 days postpartum | |
Secondary | Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge | Total morphine milligram equivalents (MME) used from discharge to 2 weeks post-discharge. MME is the amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength. | 2 weeks post discharge | |
Secondary | Worst Pain Severity Score at 2 Weeks Post Discharge | Pain severity scores assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. | 2 weeks post discharge | |
Secondary | Pain Interference Score = 4 at 2 Weeks Post Discharge | Pain interference scores = 4 on the Brief Pain Inventory (numeric scale from 0 to 10) at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. This outcome asks participants to indicate their pain scores for the week prior to completing the inventory. | 2 weeks post discharge | |
Secondary | Number of Participants Who Indicated an Improved Global Impression of Change | Number of participants who indicated an improved global impression of change in overall pain at 2 weeks post-discharge. This represents a selection on a multiple choice survey question with the response options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. | 2 weeks post discharge | |
Secondary | Infant Hospital Readmissions | Proportion of infants readmitted to the hospital | 6 weeks postpartum | |
Secondary | Maternal Depression Score = 13 | 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. | 6 weeks postpartum |
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