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Compares treatment options for Complex Obstetric Surgery
Official title COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
ClinicalTrials.gov ID: NCT06925152
What this study is testing
What is Bupivicaine intervention arm?
Bupivicaine intervention arm is an investigational medicine, given as an once-daily, being studied as a potential treatment for complex obstetric surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.