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

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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)

Regional One Health

Memphis, Tennessee, United States

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NCT06925152