Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06753500

Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial

Led by Universidad Simón Bolívar · Updated on 2025-01-28

60

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Undergoing elective or emergency laparoscopic cholecystectomy for gallstones with or without inflammation
Not Eligible

You will not qualify if you...

  • Having other biliary diseases such as biliary pancreatitis or cholangitis
  • Requiring additional procedures like bile duct exploration or conversion to open surgery
  • Experiencing anesthesia or surgical complications needing intensive care
  • Allergic to local anesthetics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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)

Post-operative Follow-up

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

Trial Site Locations

Total: 2 locations

1

Clinica Portoazul

Barranquilla, Atlantivo, Colombia, 080020

Actively Recruiting

2

clinica Iberoamerica

Barranquilla, Atlántico, Colombia, 080020

Actively Recruiting

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Research Team

J

Jorge Daes, MD

A

Andres Hanssen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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/36050617

Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial.

Jorge Daes, Rafael Pantoja, Jorge Luquetta...

https://pubmed.ncbi.nlm.nih.gov/38091501

Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial.

Jorge Daes, Andrés Hanssen, Elika Luque...

https://pubmed.ncbi.nlm.nih.gov/41530355