Status:
NOT_YET_RECRUITING
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
Regional One Health
Conditions:
Complex Obstetric Surgery
Perioperative Pain Management
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief 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 w...
Detailed Description
The Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that targets the nerves innervating the abdominal wall, providing effective postoperative analgesia for patients undergoi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion Criteria:
- Received general anesthesia
- History of less than 3 cesarean deliveries if do not meet other inclusion criteria
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06925152
Start Date
May 1 2025
End Date
May 1 2028
Last Update
April 13 2025
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