Opioid Prescription After Cesarean Trial (PACT)

The George Washington University Biostatistics Center

Status and phase: Completed; Phase 3

Conditions: Pregnancy Related; Opioid Use; Pain

Treatments: Drug: 0 to 20 tablets of oxycodone 5mg; Drug: Fixed opioid prescription

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04296396

UG1HD040512 (U.S. NIH Grant/Contract)

UG1HD040545 (U.S. NIH Grant/Contract)

UG1HD087192 (U.S. NIH Grant/Contract)

UG1HD027915 (U.S. NIH Grant/Contract)

UG1HD040560 (U.S. NIH Grant/Contract)

UG1HD040544 (U.S. NIH Grant/Contract)

UG1HD034208 (U.S. NIH Grant/Contract)

UG1HD087230 (U.S. NIH Grant/Contract)

HD036801-PACT

UG1HD053097 (U.S. NIH Grant/Contract)

UG1HD027869 (U.S. NIH Grant/Contract)

UG1HD040485 (U.S. NIH Grant/Contract)

U24HD036801 (U.S. NIH Grant/Contract)

UG1HD040500 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,521 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,521 participants in 2 patient groups

Individualized Opioid Prescription

Experimental group

Description:

Individualized opioid prescription protocol and shared decision making

Treatment:

Drug: 0 to 20 tablets of oxycodone 5mg

Fixed Opioid Prescription

Other group

Description:

Fixed opioid prescription of 20 tablets of oxycodone 5mg

Treatment:

Drug: Fixed opioid prescription