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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Intervention groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain medication requested

Total pain medication requested expressed in morphine milligram equivalents.

Time frame
Between 24 and 48 hours after surgery

Secondary outcomes

1

Total MME requested within first 24 hours postoperatively

Time frame
24 hours postoperatively
2

Total MME requested within 48 hours postoperatively

Time frame
48 hours postoperatively
3

Total MME at one week after surgery

Time frame
One week postoperatively
4

Functional assessment of activities of daily life (ADL) at one week postoperatively

Time frame
One week postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee

Lead sponsor

Regional One Health

Collaborator