Related Experiment Video
Updated: Jun 24, 2025
An Experimental Paradigm for the Prediction of Post-Operative Pain PPOP
Published on: January 27, 2010
Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial
Marcela C Smid1, Rebecca G Clifton, Kara Rood
1Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, The Ohio State University, Columbus, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, University of Pittsburgh, Pittsburgh, Pennsylvania, University of Alabama at Birmingham, Birmingham, Alabama, Brown University, Providence, Rhode Island, Columbia University, New York, New York, University of Texas Medical Branch, Galveston, Texas, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio, University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Northwestern University, Chicago, Illinois, and University of Texas at Austin, Austin, Texas; the Department of Anesthesiology, Columbia University, New York, New York; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective:
To test whether an individualized opioid-prescription protocol (IOPP) with a shared decision-making component can be used without compromising postcesarean pain management.
Methods:
In this multicenter randomized controlled noninferiority trial, we compared IOPP with shared decision making with a fixed quantity of opioid tablets at hospital discharge. We recruited at 31 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Study participants had uncomplicated cesarean births. Follow-up occurred through 12 weeks postdischarge. Individuals with complicated cesarean births or history of opioid use in the pregnancy were excluded. Participants were randomized 1:1 to IOPP with shared decision making or fixed quantity (20 tablets of 5 mg oxycodone). In the IOPP group, we calculated recommended tablet quantity based on opioid use in the 24 hours before discharge. After an educational module and shared decision making, participants selected a quantity of discharge tablets (up to 20). The primary outcome was moderate to severe pain (score 4 or higher [possible range 0-10]) on the BPI (Brief Pain Inventory) at 1 week after discharge. A total sample size of 5,500 participants was planned to assess whether IOPP with shared decision making was not inferior to the fixed quantity of 20 tablets.
Results:
From September 2020 to March 2022, 18,990 individuals were screened and 5,521 were enrolled (n=2,748 IOPP group, n=2,773 fixed-quantity group). For the primary outcome, IOPP with shared decision making was not inferior to fixed quantity (59.5% vs 60.1%, risk difference 0.67%; 95% CI, -2.03% to 3.37%, noninferiority margin -5.0) and resulted in significantly fewer tablets received (median 14 [interquartile range 4-20] vs 20, P <.001) through 90 days postpartum.
Conclusion:
Compared with fixed quantity, IOPP with shared decision making was noninferior for outpatient postcesarean analgesia at 1 week postdischarge and resulted in fewer prescribed opioid tablets at discharge.
Clinical Trial Registration:
ClinicalTrials.gov, NCT04296396.
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