A randomized trial of individualized opioid prescription protocol versus fixed quantity for post-cesarean pain management

Abstract

To evaluate whether an individualized opioid prescription protocol (IOPP) with a shared decision-making component is non-inferior to a fixed quantity prescription of opioid tablets for outpatient cesarean pain management at 1-week post-discharge. We performed a non-inferiority open-label trial at 31 US sites (NCT04296396). Prior to hospital discharge, participants who had undergone cesarean delivery were randomly assigned to IOPP or fixed quantity (20 tablets of 5mg oxycodone) and followed through 90 days postpartum. In the IOPP group, individuals received education on post-operative pain expectations, opioid side effects, and the number of recommended tablets based on their morphine milligram equivalent (MME) use in the past 24 hours. They then selected a quantity of post-discharge tablets (up to 20) to be prescribed. The primary outcome was moderate to severe pain (≥ 4) at 1-week post-discharge on the Brief Pain Inventory (BPI, 0-10) in the last 24 hrs. Secondary outcomes were pain scores and post-discharge opioid prescriptions within 90 days. A planned sample size of 5500 tested non-inferiority of IOPP compared to fixed quantity assuming 90% power, type I error 0.025 1-sided and inferiority margin of 5%. From Sep 2020 through March 2022, of 9963 eligible individuals, 5520 (55%) were enrolled (n=2748 IOPP, n=2772 fixed). Baseline characteristics were similar between groups. In the IOPP group, participants requested a median of 14 tablets (IQR range 6-20). The primary outcome rate was not inferior between the IOPP and fixed groups (59% vs. 60%, Risk Difference -0.7; 95% CI -3.4, 2.0), and worst pain was similar throughout follow-up (Figure). The proportion filling an opioid prescription after discharge was similar between groups (7.6% vs 6.2%, relative risk 1.22, 95% CI [1.00, 1.48]). Reported opioid-related side effects were similar between groups (13.5% vs. 13.9%, p=0.7). Compared to fixed quantity opioid prescription, IOPP was non-inferior for outpatient post-cesarean pain management at 1-week post discharge.