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

NCT06925152 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-11

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Bupivicaine intervention arm

TAP blocks in intervention group will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine

DRUG

Placebo arm

Placebo group TAP block syringe will include 30mL normal saline

Sponsors & Collaborators

  • Regional One Health

    collaborator OTHER

  • University of Tennessee

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06925152 on ClinicalTrials.gov