What this study is
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).
What's being tested
- Bupivicaine intervention arm
Intervention · DRUG
TAP blocks in intervention group will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine
- Placebo arm
Intervention · DRUG
Placebo group TAP block syringe will include 30mL normal saline
Study details
- Sponsor
- University of Tennessee
- Conditions
- Complex Obstetric Surgery · Perioperative Pain Management · Cesarean Delivery · Postoperative Pain Control
- Enrolling
- 120 people
- Starts
- 2025-07-15
- Est. completion
- 2028-05
- Design
- Quadruple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRegional One Health
Memphis, Tennessee, United States
- Michael Vandillen, MD · Contact314-619-1046mvandill@uthsc.edu
Recruiting
Study team
Sponsor
University of Tennessee
Study ID COMFORT2025
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.