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

Launched by UNIVERSITY OF TENNESSEE · Apr 5, 2025

Keywords

ClinConnect Summary

The COMFORT Trial is studying a method to help manage pain after cesarean deliveries, especially for women who have had complex surgeries. The researchers want to see if a specific type of pain relief technique, called a transversus abdominis plane (TAP) block, can reduce the amount of opioid pain medication needed after surgery. The trial will include women aged 18 to 62 who have had certain medical histories, like multiple cesarean deliveries or previous abdominal surgeries.

If you qualify for this trial, you can expect to receive the TAP block during your surgery, which may help you feel less pain afterward and use fewer opioids for pain control. However, there are some criteria that might exclude you, such as having a history of chronic opioid use or certain medical conditions. This trial is not yet recruiting participants, but it aims to improve pain management for women undergoing cesarean deliveries in complex situations.

Gender

FEMALE

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 abdominoplasty
• • History of abdominal re-exploration surgery
• Exclusion Criteria:
• • 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