NCT06925152 COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
| NCT ID | NCT06925152 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Tennessee |
| Condition | Complex Obstetric Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-07-15 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess the effect of intraoperative transversus abdominis plane (TAP) blocks on the amount of opioid pain medications expressed as morphine milliequivalents (MME) used postoperatively in patients who have undergone cesarean delivery (CD) in the setting of complex obstetric surgery (COS).
Eligibility 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 abdominoplasty * History of abdominal re-exploration surgery Exclusion Criteria: * Received general anesthesia * 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 * Cesarean hysterectomy * Administration of ≥4mg morphine to epidural * Loss to follow-up
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06925152 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Complex Obstetric Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06925152 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06925152 currently recruiting?
Yes, NCT06925152 is actively recruiting participants. Contact the research team at mvandill@uthsc.edu for enrollment information.
Where is the NCT06925152 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT06925152 clinical trial?
NCT06925152 is sponsored by University of Tennessee. The trial plans to enroll 120 participants.