Actively Recruiting
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Led by University of Tennessee · Updated on 2026-03-11
120
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
U
University of Tennessee
Lead Sponsor
R
Regional One Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 50 years
- History of at 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 will not qualify if you...
- Received general anesthesia
- History of fewer than 3 cesarean deliveries if none of the other inclusion criteria are met
- History of chronic opioid use
- History of substance abuse including alcohol, methamphetamine/amphetamine, prescription opioid abuse, or heroin use
- History of chronic kidney disease
- Allergies to bupivacaine or oral analgesics
- Patient preference not to participate
- Cesarean hysterectomy
- Administration of 4 mg or more morphine to epidural
- Lost to follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Regional One Health
Memphis, Tennessee, United States, 38103
Actively Recruiting
Research Team
M
Michael VanDillen Fellow physician, PI of study, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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