Opioid Prescription After Cesarean Trial

Pain Clinical Trial

— PACT  

Official title:

Prescription After Cesarean Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296396
• Other study ID #: HD036801-PACT
• Secondary ID: U24HD036801UG1HD
• Status: Completed
• Phase: Phase 3
• Start date: September 21, 2020
• Est. completion date: July 8, 2022

Study information

• Verified date: September 2023
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Opioid Use
• Pain
• Pregnancy Related

Intervention

Drug:
• 0 to 20 tablets of oxycodone 5mg
Individualized opioid prescription protocol (IOPP) that includes shared decision making
• Fixed opioid prescription
20 tablets of oxycodone 5mg

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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