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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5,521
Individualized opioid prescription protocol (IOPP) that includes shared decision making
20 tablets of oxycodone 5mg
University of Alabama - Birmingham
Birmingham, Alabama, United States
Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
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.
Time frame: 1 week post hospital discharge
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
Time frame: After hospital discharge and up to 90 days postpartum
Number of Opioid Prescriptions Filled
Number of opioid prescriptions filled by ninety days postpartum
Time frame: 90 days postpartum
Number of Opioid Tablets Unused Since Discharge
Number of opioid tablets unused from discharge to 90 days postpartum
Time frame: 90 days postpartum
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.
Time frame: 2 weeks post discharge
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.
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University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve-Metrohealth
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, 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 Texas Medical Branch
Galveston, Texas, United States
...and 2 more locations
Time frame: 2 weeks post discharge
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.
Time frame: 2 weeks post discharge
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.
Time frame: 2 weeks post discharge
Infant Hospital Readmissions
Proportion of infants readmitted to the hospital
Time frame: 6 weeks postpartum
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.
Time frame: 6 weeks postpartum