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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Complex Obstetric Surgery, Perioperative Pain Management, Cesarean Delivery, Postoperative Pain Control

In brief

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).

Key facts

Study ID

NCT06925152

Run by

University of Tennessee

People needed

120

Starts

2025-07-15

Expected to finish

2028-05-01

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Regional One Health — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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