The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.
John G McDonnell, Brian O'Donnell, Gerard Curley...
https://pubmed.ncbi.nlm.nih.gov/17179269Actively Recruiting
Phase 4
Age: 18Years - 50Years
FEMALE
ID06925152
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Led by University of Tennessee · Updated on 2026-03-11
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Tennessee
Lead Sponsor
R
Regional One Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how intraoperative transversus abdominis plane (TAP) blocks affect the amount of opioid pain medication needed after cesarean delivery during complex obstetric surgery. This study focuses on whether using bupivacaine in TAP blocks can reduce opioid use and improve pain control following surgery. The trial aims to fill gaps in understanding the role of TAP blocks specifically for high-risk or complicated cesarean deliveries. Participants are randomly assigned to one of two groups: one receives a TAP block with 0.5% bupivacaine mixed with saline, and the other receives a placebo TAP block with saline only. The TAP blocks are applied during surgery, and the study compares opioid consumption and pain outcomes between these groups. The trial uses a quadruple-blind design to ensure unbiased results. During the study, researchers will track opioid pain medication usage between 24 and 48 hours after surgery as the primary outcome. They will also look at opioid use within the first 24 hours and up to one week, assess daily living activities after one week, and monitor unplanned postoperative visits for six months. Additional data on patients' geographic regions will be collected to explore diversity and inclusion. Participants' pain, opioid use, and recovery will be carefully monitored throughout the study period, which lasts up to six months post-surgery.
CONDITIONS
Brief Title
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Patient has a history of at 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
- Female aged 18 to 50 years
You will not qualify if you...
- Received general anesthesia
- History of fewer than three cesarean deliveries if other inclusion criteria are not met
- History of chronic opioid use
- History of substance abuse (alcohol, methamphetamine/amphetamine, prescription opioid abuse, or heroin use)
- History of chronic kidney disease
- Allergies to bupivacaine or oral analgesics
- Patient preference not to participate
- Cesarean hysterectomy
- Administration of 4 mg or more morphine to epidural
- Loss to follow-up
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants undergo complex cesarean delivery surgery during which an intraoperative TAP block with either bupivacaine or placebo is administered to manage postoperative pain.
1 surgical visit (in-person)
Follow-up
Duration - Up to 6 months post-surgery
Participants are monitored for postoperative pain medication use, functional recovery, and any unplanned postoperative visits over several weeks to months after surgery.
Multiple follow-up visits including assessments at 24 hours, 48 hours, 1 week, and up to 6 months postoperatively
Trial Site Locations
Total: 1 location
1
Regional One Health
Memphis, Tennessee, United States, 38103
Actively Recruiting
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Research Team
M
Michael VanDillen Fellow physician, PI of study, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis.
N Johns, S O'Neill, N T Ventham...
https://pubmed.ncbi.nlm.nih.gov/22632762Efficacy of Single Wound Infiltration With Bupivacaine and Adrenaline During Cesarean Delivery for Reduction of Postoperative Pain: A Randomized Clinical Trial.
Gali Garmi, Mark Parasol, Noah Zafran...
https://pubmed.ncbi.nlm.nih.gov/36378307Transversus abdominis plane block for postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A systematic review and meta-analysis.
F W Abdallah, S H Halpern, C B Margarido
https://pubmed.ncbi.nlm.nih.gov/22907337