Effect of pannus elevation device on postoperative pain after cesarean delivery: a randomized controlled trial

Abstract

This study examines whether an abdominal pannus elevation device decreases opioid use and improves postoperative pain after cesarean birth. The device adheres to the pannus allowing it to be positioned away from the incision during wound healing and can be repositioned during use over several days. Patients >18 years old were randomized 1:1 device versus no device on postoperative day 1 following cesarean birth. Patients with vertical skin incision or chronic opioid use were excluded. Participants were surveyed at 10 days post-delivery about opioid tablets remaining and pain satisfaction. Primary outcome was total morphine milligram equivalents (MME) used postpartum. Secondary outcomes were inpatient and outpatient opioid use, pain scores, and PROMIS 29 scores. We determined that 216 participants were required to detect a 40% reduction in MME using 80% power with an alpha of 5%. We estimated 20% lost to follow up for primary outcome. We planned an a priori subgroup analysis of obese patients (BMI>30) since they may uniquely benefit from pannus elevation. Of 538 patients screened, 484 (90%) qualified and 275 (56%) consented for randomization. Fifty-three (19%) were lost to follow up leaving 222 (118 device vs 104 control) for analysis (Figure). Follow up frequency was similar between groups (p=.09). Demographic and clinical characteristics were similar between groups. Median device use was 5 days (IQR 3-9). There were no statistically significant differences in MME, other opioid use measures, or pain satisfaction outcomes (Table). A 20% reduction in primary outcome as well as lower pain scores were observed, and 64% of participants randomized to device stated they would use it after another birth but these did not reach statistical significance. We observed similar trends among obese participants (N=152). Surgical site infection was rare (n=3) and was not assessed. A pannus elevation device did not reduce total opioid use by 40% after cesarean. This study may be underpowered to detect smaller but clinically significant differences, especially among obese patients.View Large Image Figure ViewerDownload Hi-res image Download (PPT)