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NCT Number: NCT06753500

Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to improve visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Portoazul, Barranquilla, Atlantivo, Colombia

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About this study

Introduction

Laparoscopic cholecystectomy is the second most commonly performed procedure by general surgeons. While laparoscopy results in shorter recovery times and less intense pain compared to open surgery, it does not entirely eliminate postoperative pain, which remains the primary reason for hospitalization or readmission. Consequently, most patients undergoing laparoscopic cholecystectomy require hospitalization for 24 to 48 hours.

Postoperative pain frequently occurs after cholecystectomy, stemming from surgical incisions, manipulation of surrounding tissues, and postoperative inflammation. Various methods for pain control have been investigated, including analgesics, anti-inflammatory medication, peripheral nerve blocks, and physical interventions.

This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to enhance visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.

Justification

To date, no studies have shown the effect of visceral blockade on postoperative pain control in laparoscopic cholecystectomy. With the advancement of minimally invasive surgery, outpatient management of patients has become a realistic goal, presenting a challenge for surgeons to achieve adequate pain control and quicker recovery. Blocking the hepatoduodenal ligament provides an alternative for managing visceral pain by targeting the hepatic branches of the celiac plexus.

Objectives

General Objective To evaluate the effect of intraoperative infiltration of Bupivacaine and Dexamethasone into the hepatoduodenal ligament and the visceral peritoneum reflection of the gallbladder cystic plate (autonomic blockade) on postoperative pain and analgesic requirements in patients undergoing laparoscopic cholecystectomy.

Specific Objectives

  • To evaluate whether autonomic blockade reduces the consumption of postoperative opioid analgesics.
  • To assess whether autonomic blockade shortens hospital stay duration.
  • To determine whether autonomic blockade decreases the incidence of nausea and vomiting during the immediate postoperative period.
  • To evaluate the impact of autonomic blockade on hospitalization requirements (versus outpatient surgery) and the rate of readmissions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective or emergency laparoscopic cholecystectomy for cholelithiasis with or without cholecystitis.

Exclusion criteria

  • Associated biliary pathologies (e.g., biliary pancreatitis, cholangitis).
  • Additional procedures, such as formal bile duct exploration. Conversion to an open approach
  • Anesthesia or Surgical complications that require intensive care unit
  • Allergies to local anesthetics

Treatment and study plan

Autonomic neural blockade

Procedure

Autonomic nerve block performed with:

  • Bupivacaine: 20 mL of 0.5%.
  • Dexamethasone: 8 mg.

Other names: BLOCKADE

Primary outcomes

  1. postoperative analgesic doses

    Time frame: up to 72 hours

    acetaminophen 1g oral tablets

  2. postoperative analgesic doses-rescue 1

    Time frame: up to 72 hours

    Ibuprofen 400 mg oral tablets

  3. postoperative analgesic doses-rescue 2

    Time frame: up to 72 hours

    acetaminophen 300 mg plus codeine 8 mg oral tablets

  4. postoperative analgesic-rescue 3

    Time frame: up to 72 hours

    Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules

Secondary outcomes

  1. pain level

    Time frame: 1, 24 and 48 hours after surgery

    Visual Analog Scale (VAS) scores will be recorded (0-10)

Other outcomes

  1. postoperative nausea

    Time frame: 1,8 and 24 hours after surgery

    presence of nausea

  2. postoperative vomiting

    Time frame: 1,8,24 hours after surgery

    presence of vomiting

Study contacts

Contact information is provided by the study sponsor or research team.

Andres Hanssen, MD

CONTACT

[email protected]

+573123012321

Jorge Daes, MD

CONTACT

[email protected]

+573106363636

Sponsors and collaborators

Lead sponsor

Universidad Simón Bolívar

Other

Registry information

Official study title

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

Acronym: ANB

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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