COMFORT trial protocol: a triple-blind randomized controlled trial of surgeon-administered TAP block during complex cesarean delivery

The COMFORT Trial (Complex Obstetric Management with Focused Regional Transversus Abdominis Plane Block) is a randomized controlled trial evaluating postoperative pain management in complex cesarean delivery. Transversus abdominis plane (TAP) blocks are commonly performed using local anesthetics such as bupivacaine and have been shown to reduce postoperative opioid consumption and improve pain control. When administered intraoperatively, TAP blocks may provide early and prolonged analgesia, potentially reducing opioid requirements and improving postoperative recovery. However, most studies evaluating TAP blocks in obstetrics have focused on routine Pfannenstiel cesarean deliveries. Limited data exist regarding their effectiveness in more complex obstetric surgeries, such as cesarean deliveries complicated by dense adhesions or other operative challenges. Optimizing postoperative pain management while minimizing opioid exposure remains an important priority in obstetric care. Despite the widespread use of TAP blocks, the role of intraoperative bupivacaine TAP block placement in complex obstetric surgery remains underexplored. This triple-blind randomized controlled trial aims to evaluate whether intraoperative TAP block placement with bupivacaine during complex cesarean deliveries reduces cumulative postoperative opioid consumption at 24 hours and 48 hours after surgery, expressed as morphine milligram equivalents, and improves postoperative analgesia. www.clinicaltrials.gov identifier is NCT06925152 What is this study about? Some C-sections are more complex than others, such as when a person has had several C-sections, has had other abdominal surgery, or has scar tissue from previous surgery. Recovery from these surgeries can be more painful. After surgery, many patients get strong pain medicines called opioids. Opioids work well, but they can cause side effects, and some people keep using them long after surgery. Doctors want to control pain while using fewer opioids. In this study, the surgeon injects numbing medicine into the layers of the belly wall during the C-section in hopes to decrease postoperative pain. How does the study work? Patients are placed by chance into one of two groups. One group gets the numbing medicine. The other gets a placebo. The patient, their surgeons, and the people measuring the results do not know who is in which group. Everyone gets the usual post-operative pain medications. What is being measured? The main question is how much opioid medicine women use in the first one and two days after surgery. The study also looks at pain, and at everyday activities one week later. Who is taking part? Up to 120 pregnant patients having a difficult C-section at one hospital in Memphis, Tennessee. Why does this matter? If it works, the numbing shot could help patients recover from difficult C-sections with less opioid medicine.