RecruitingPhase 4NCT06925152
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Sponsor
University of Tennessee
Enrollment
120 participants
Start Date
Jul 15, 2025
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years
Inclusion Criteria15
- 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
- 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 Criteria1
- Received general anesthesia
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGBupivicaine intervention arm
TAP blocks in intervention group will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine
DRUGPlacebo arm
Placebo group TAP block syringe will include 30mL normal saline
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06925152