COMFORT Trial: Pain Management for Complex Cesarean Deliveries

This study, called the COMFORT Trial, is looking at how well a nerve block called a Transversus Abdominis Plane (TAP) block helps manage pain after complex cesarean deliveries. If you join, you would receive either bupivacaine (a numbing medicine) or a placebo (saltwater) as part of your TAP block during surgery. The researchers want to see if bupivacaine reduces the amount of opioid pain medicine you need after surgery. You may be able to join if you are a woman between 18 and 50 years old and have a history of certain abdominal surgeries or three or more prior cesarean deliveries. The study will measure how much pain medication you request between 24 and 48 hours after surgery. The current status of this study is unclear.

Study design
This interventional study plans to enroll 120 women. Participants will be randomly assigned to receive either bupivacaine or a placebo as part of their TAP block.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain medication requests will be measured between 24 and 48 hours after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06925152

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

Recruiting
PHASE4Ages 18–50InterventionalTreatment
University of Tennessee
~120 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Bupivicaine intervention armPlacebo arm

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain medication requested
Measured over Between 24 and 48 hours after surgery
Complex Obstetric Surgery
Perioperative Pain Management
Cesarean Delivery
Postoperative Pain Control
1 sites across 1 states
Tennessee1
Michael VanDillen Fellow physician, PI of study, MD
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Eligibility criteria

Inclusion

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
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

Exclusion

Received general anesthesia
  • Pain medication requestedBetween 24 and 48 hours after surgery

    Total pain medication requested expressed in morphine milligram equivalents.