Complex cesarean delivery with an intraoperative transversus abdominis plane (TAP) block
Official title: COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Run by University of Tennessee · NCT06925152 · Data updated 2026-11-12
This study tests whether giving a TAP nerve block with bupivacaine during complex cesarean deliveries lowers the amount of opioid pain medicine patients need after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | University of Tennessee Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | July 15, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06925152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients having a cesarean delivery with features of complex obstetric surgery (for example prior laparotomy, adhesions, or three or more prior cesareans) who are not chronic opioid users and are receiving neuraxial rather than general anesthesia.
✕Probably not a fit
Patients who have chronic opioid use or substance abuse, chronic kidney disease, allergies to bupivacaine or oral analgesics, those undergoing cesarean hysterectomy, or those who receive general anesthesia are unlikely to benefit or are excluded from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional Phase 4 study enrolls patients undergoing cesarean delivery in the setting of complex obstetric surgery and compares an intraoperative TAP block with bupivacaine versus a placebo TAP block. Participants receive the assigned TAP intervention during their cesarean and postoperative opioid use is tracked and converted to morphine milliequivalents (MME) to measure opioid consumption. The trial focuses on patients with prior abdominal surgeries, adhesions, multiple prior cesareans, or other factors that increase surgical complexity. The primary outcome is postoperative opioid use, with secondary interest in pain control and recovery measures at the single study site.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative opioid requirements and improve pain control and recovery after complex cesarean deliveries.
How similar studies have gone: Previous randomized and observational studies in lower abdominal and cesarean surgery have shown intraoperative TAP blocks can reduce opioid consumption and improve pain scores, supporting the rationale for this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: Patient has a history of a least one of the following: * Prior exploratory laparotomy * History of non-obstetric open intra-abdominal surgery * History of three or more prior cesarean deliveries * History of intra-abdominal or pelvic adhesive disease * History of abdominal re-exploration surgery Exclusion Criteria: * Planned general anesthesia * Supraumbilical skin incision * History of less than 3 cesarean deliveries if do not meet other inclusion criteria * History of chronic opioid use * History of substance abuse (i.e. alcohol, methamphetamine/amphetamine, abuse of prescription opioid medication, or heroin use) * History of chronic kidney disease * Allergies to bupivacaine or oral analgesics * Patient preference * Planned cesarean hysterectomy * Administration of \>4mg morphine to epidural
Where it's running
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Regional One Health
Memphis, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Michael VanDillen Fellow physician, PI of study, MD
- Email: mvandill@uthsc.edu
- Phone: 901-646-1321
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.