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

Abstract

Background: Suboptimal treatment of postpartum pain is associated with persistent pain and postpartum depression. Multimodal analgesia can achieve superior pain relief and decreased opioid consumption after surgery. There is limited and conflicting data on abdominal support devices to reduce postoperative pain and opioid use after cesarean delivery.

Objective: This study aimed to examine whether the use of a panniculus elevation device decreases opioid use and improves postoperative pain after cesarean delivery.

Study design: This was an unblinded prospective trial in which eligible, consenting patients aged ≥18 years were randomized to the panniculus elevation device group or no device group within 36 hours after cesarean delivery. The device studied adheres to the abdomen and lifts the panniculus. Moreover, it can be repositioned during use. Patients with a vertical skin incision or chronic opioid use disorder were excluded. Participants were surveyed 10 and 14 days after delivery about opioid use and pain satisfaction. The primary outcome was total morphine milligram equivalents used after delivery. The secondary outcomes were inpatient and outpatient opioid use, subjective pain scores, and Patient-Reported Outcomes Measurement Information System pain interference scores. An a priori subgroup analysis was performed on participants with obesity who may uniquely benefit from panniculus elevation.

Results: Of 538 patients screened for inclusion from April 2021 to July 2022, 484 were eligible, and 278 were consented and randomized. Moreover, 56 participants (20%) were lost to follow-up, leaving 222 (118 in the device group vs 104 in the control group) for analysis. Follow-up frequency was similar between groups (P=.09). Demographic and clinical characteristics were similar between groups. There was no statistically significant difference in total opioid use, other opioid use measures, or pain satisfaction outcomes. Median device use was 5 days (interquartile range, 3-9), and 64% of participants randomized to device use stated that they would use it again. Here, similar trends were observed among participants with obesity (n=152).

Conclusion: The use of a panniculus elevation device did not significantly reduce total opioid use after cesarean delivery in patients.

Trial registration: ClinicalTrials.gov NCT04797637.

Keywords: cesarean delivery; multimodal analgesia; postoperative pain.