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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
University of Tennessee
Study ID
NCT06925152
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cesarean Delivery
  • Complex Obstetric Surgery
  • Perioperative Pain Management
  • Postoperative Pain Control

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Bupivicaine intervention arm — DRUG
    TAP blocks in intervention group will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine
  • Placebo arm — DRUG
    Placebo group TAP block syringe will include 30mL normal saline

Study Details

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 Dates

Start date
Jul 15, 2025
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo group
    Placebo group TAP (Transversus Abdominis Plane) block syringe will include 30mL normal saline.
  • Active Comparator: Intervention group
    TAP (Transversus Abdominis Plane) blocks will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine.

Primary Outcome Measure

Pain medication requested [ Time Frame: Between 24 and 48 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Regional One HealthMemphisTennessee38103
Michael Vandillen, MD
[email protected]
314-619-1046

Find similar trials in Memphis, TN

By research site
Regional One Health· Memphis, TN

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