Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial.
Jorge Daes, David J Morrell, Andrés Hanssen...
https://pubmed.ncbi.nlm.nih.gov/36050617Actively Recruiting
Phase Not Applicable
Age: 20Years - 50Years
All Genders
ID06973122
Effect of Combined Paragastric Autonomic Neural Blockade and Laparoscopic Assisted Transversus Abdominis Plane Block on Visceral Pain After Bariatric Surgery
Led by Alexandria University · Updated on 2025-05-15
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating visceral pain, a common and challenging issue after laparoscopic bariatric surgery, which often causes nausea and vomiting and does not respond well to usual pain treatments. This study aims to evaluate the effect of combining paragastric autonomic neural blockade with laparoscopic assisted transversus abdominis plane block on reducing visceral pain during and shortly after surgery. Participants will be randomly assigned to one of two groups: one group will receive general anesthesia along with both the paragastric autonomic neural blockade and the transversus abdominis plane block, while the other group will receive general anesthesia with only the transversus abdominis plane block. The neural blockades involve injecting anesthetic near specific nerves during surgery to potentially reduce pain signals. Both groups will receive standard anesthesia and pain medications during the procedure. During the study, patients will be monitored for pain levels using a visual analog scale at several time points up to 24 hours after surgery. Researchers will also track opioid use, time to first rescue pain medication, nausea, vomiting, and vital signs. Safety and effectiveness of the pain control methods will be assessed in a double-blind, randomized manner with follow-up in the post-anesthesia care unit and hospital ward. The total participation period covers surgery and the early postoperative phase.
CONDITIONS
Brief Title
Paragastric Neural Blockade and Laparoscopic Assisted Transversus Abdominis Plane Block on Visceral Pain After Surgery
Who Can Participate
Age: 20Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 20 and 50 years, any sex
- ASA physical status class I to III
- Body mass index (BMI) between 35 and 50 kg/m²
You will not qualify if you...
- Severe cardiac disorder
- Chronic renal failure
- Liver cirrhosis
- Allergy to bupivacaine
- History of chronic opioid use
- Glycosylated hemoglobin (HBA1C) higher than 7%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo laparoscopic bariatric surgery under general anesthesia with either combined paragastric autonomic neural blockade and laparoscopic assisted transversus abdominis plane block or laparoscopic assisted transversus abdominis plane block alone. After surgery, participants are monitored in the post-anesthesia care unit (PACU) where pain and nausea are assessed.
1 visit (in-person on surgery day and PACU stay)
Post-operative Follow-up
Duration - Up to 24 hours after surgery
Participants are monitored for pain levels, opioid use, nausea, and vomiting during the first 24 hours after surgery with assessments at 4, 8, 12, and 24 hours. Pain control continues in the hospital ward with medications as needed.
Multiple assessments in hospital within 24 hours
Trial Site Locations
Total: 1 location
1
Alexandria University
Alexandria, Egypt
Actively Recruiting
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Research Team
S
sarah m elgamal, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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