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NCT06925152
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Conditions: Complex Obstetric Surgery, Perioperative Pain Management, Cesarean Delivery, Postoperative Pain Control
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 120
Sponsor: University of Tennessee
Location: Regional One Health Memphis Tennessee
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 Criteria
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 abdominal re-exploration surgery
Exclusion Criteria:
* Planned general anesthesia
* Supraumbilical skin incision
* 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
* Planned cesarean hysterectomy
* Administration of \>4mg morphine to epidural
Source: ClinicalTrials.gov (NCT06925152). StuddyBuddy aggregates publicly available trial information.