Opioid Prescription After Cesarean Trial

Phase 3

Completed

Conditions: Pregnancy Related
Opioid Use
Pain

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

Registration Number: NCT04296396

Lead Sponsor: The George Washington University Biostatistics Center

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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 5521

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Opioid Prescription	0 to 20 tablets of oxycodone 5mg	Individualized opioid prescription protocol and shared decision making
Fixed Opioid Prescription	Fixed opioid prescription	Fixed opioid prescription of 20 tablets of oxycodone 5mg

Primary Outcome Measures

Name	Time	Method
Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory	1 week post hospital discharge	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge	After hospital discharge and up to 90 days postpartum	Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum
Number of Opioid Prescriptions Filled	90 days postpartum	Number of opioid prescriptions filled by ninety days postpartum
Number of Opioid Tablets Unused Since Discharge	90 days postpartum	Number of opioid tablets unused from discharge to 90 days postpartum
Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge	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.
Worst Pain Severity Score at 2 Weeks Post Discharge	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.
Pain Interference Score ≥ 4 at 2 Weeks Post Discharge	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.
Number of Participants Who Indicated an Improved Global Impression of Change	2 weeks post discharge	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.
Infant Hospital Readmissions	6 weeks postpartum	Proportion of infants readmitted to the hospital
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.

Trial Locations

Locations (12): University of Alabama - Birmingham
🇺🇸
Birmingham, Alabama, United States
Northwestern University
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Chicago, Illinois, United States
Columbia University
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New York, New York, United States
University of North Carolina-Chapel Hill
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Chapel Hill, North Carolina, United States
Case Western Reserve-Metrohealth
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Cleveland, Ohio, United States
Ohio State University
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Columbus, Ohio, United States
Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Magee Womens Hospital of UPMC
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Pittsburgh, Pennsylvania, United States
Brown Univeristy
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Providence, Rhode Island, United States
University of Texas Medical Branch
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Galveston, Texas, United States
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University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States