COMFORT Trial Evaluating Intraoperative Bupivacaine TAP Blocks for Pain Control After Complex Cesarean Delivery

What this Trial Is About

Researchers are evaluating how intraoperative transversus abdominis plane TAP blocks affect the amount of opioid pain medication needed after cesarean delivery during complex obstetric surgery. This study focuses on whether using bupivacaine in TAP blocks can reduce opioid use and improve pain control following surgery. The trial aims to fill gaps in understanding the role of TAP blocks specifically for high-risk or complicated cesarean deliveries. Participants are randomly assigned to one of two groups one receives a TAP block with 0.5% bupivacaine mixed with saline, and the other receives a placebo TAP block with saline only. The TAP blocks are applied during surgery, and the study compares opioid consumption and pain outcomes between these groups. The trial uses a quadruple-blind design to ensure unbiased results. During the study, researchers will track opioid pain medication usage between 24 and 48 hours after surgery as the primary outcome. They will also look at opioid use within the first 24 hours and up to one week, assess daily living activities after one week, and monitor unplanned postoperative visits for six months. Additional data on patients geographic regions will be collected to explore diversity and inclusion. Participants pain, opioid use, and recovery will be carefully monitored throughout the study period, which lasts up to six months post-surgery.

COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block