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
Led by Universidad Simón Bolívar · Updated on 2025-01-28
60
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating the use of a combined injection of Bupivacaine, a long-acting local anesthetic, and Dexamethasone, a corticosteroid, during laparoscopic cholecystectomy surgery. The goal is to block the hepatic branches of the celiac plexus by infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate. This approach aims to improve control of visceral pain after surgery, reduce the need for pain medications, decrease nausea and vomiting, and lower hospital readmissions, thus aiding recovery. Participants will be randomly assigned to one of two groups. One group will receive the autonomic nerve block involving a percutaneous injection of 20 mL of 0.5% Bupivacaine and 8 mg of Dexamethasone under direct laparoscopic visualization into the targeted areas. The other group will undergo the standard laparoscopic cholecystectomy procedure without this nerve block. The study is double-blind, meaning neither the participants nor the researchers know who receives the nerve block. During the study, participants will be monitored for up to 72 hours after surgery to record the doses of postoperative analgesics used, including rescue medications. Pain levels will be assessed at 1, 24, and 48 hours after the operation. Researchers will also observe hospital stay duration, incidence of nausea and vomiting, and readmission rates. This monitoring aims to evaluate the effectiveness of the autonomic blockade in managing postoperative pain and related symptoms. The trial is expected to run until November 2025.
CONDITIONS
Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical day
Participants undergo laparoscopic cholecystectomy, with or without intraoperative autonomic neural blockade using Bupivacaine and Dexamethasone to help control postoperative pain.
1 visit (in-person, surgical procedure)
Duration - Up to 3 days (72 hours)
Participants are monitored for postoperative pain, analgesic use, nausea, vomiting, and hospital stay duration for up to 72 hours after surgery.
Approximately 1 to 3 visits during hospital stay
Total: 2 locations
1
Clinica Portoazul
Barranquilla, Atlantivo, Colombia, 080020
Actively Recruiting
2
clinica Iberoamerica
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
J
Jorge Daes, MD
A
Andres Hanssen, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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