Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial.

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.
Competing Interests: Financial Disclosure Unrelated to this work, Marcela C. Smid reports that she serves as a consultant for Gilead Science Inc and Alydia/Organon. Her institution receives research funding from both organizations. Rebecca Clifton reports payment from the University of Arkansas for Medical Sciences for DSMB reviews. Sindhu Srinivas reports receiving payments from Goodall, Decries, Leech & Dawn, LLP, and Huff Powell Bailey. Ruth Landau reports receiving payments from PACIRA Biosciences and Regional Anesthesia and Pain Medicine. Cora MacPherson reports receiving payments from PCORI and Natera. The other authors did not report any potential conflicts of interest.
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