Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized 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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama - Birmingham
Birmingham, Alabama 35233
Contact:
Janatha Grant, RN
205-996-6268
jsgrant@uabmc.edu

More Details

Status
Recruiting
Sponsor
The George Washington University Biostatistics Center

Study Contact

Rebecca Clifton, Ph.D.
301-881-9260
rclifton@bsc.gwu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.