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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Tennessee

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Bupivicaine intervention arm
  • Placebo arm

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Tennessee

Lead sponsor

Regional One Health

Collaborator