Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial
Document Type
Journal Article
Publication Date
6-10-2024
Journal
Obstetrics and gynecology
DOI
10.1097/AOG.0000000000005649
Abstract
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.
APA Citation
Smid, Marcela C.; Clifton, Rebecca G.; Rood, Kara; Srinivas, Sindhu; Simhan, Hyagriv N.; Casey, Brian M.; Longo, Monica; Landau, Ruth; MacPherson, Cora; Bartholomew, Anna; Sowles, Amber; Reddy, Uma M.; Rouse, Dwight J.; Bailit, Jennifer L.; Thorp, John M.; Chauhan, Suneet P.; Saade, George R.; Grobman, William A.; and Macones, George A., "Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial" (2024). GW Authored Works. Paper 5125.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/5125
Department
Epidemiology