Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy (ANB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Opioid Use; Visceral Pain; Postoperative Nausea; Postoperative Vomiting
• Intervention / Treatment: Procedure: Autonomic neural blockade

Detailed Description

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

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jorge Daes, MD; Phone Number: +573106363636; Email: jorgedaez@gmail.com
• Study Contact Backup: Name: Andres Hanssen, MD; Phone Number: +573123012321; Email: anhanssen@gmail.com

Study Locations

• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Recruiting
      • clinica Iberoamerica
      • Contact: Roberto Tarud; Phone Number: +57 3184187524; Email: rtarud@colsanitas.com
  • Atlantivo
    • Barranquilla, Atlantivo, Colombia, 080020
      • Recruiting
      • Clinica Portoazul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autonomic Neural Blockade; This group will receive the Autonomic nerve block performed with: Bupivacaine: 20 mL of 0.5%.; Dexamethasone: 8 mg. Procedure: Percutaneous injection under direct laparoscopic visualization into the hepatoduodenal ligament and the visceral peritoneal reflection.	Procedure: Autonomic neural blockade; Autonomic nerve block performed with: Bupivacaine: 20 mL of 0.5%.; Dexamethasone: 8 mg.; Other Names: BLOCKADE
No Intervention: NO BLOCKADE; Patients will undergo a laparoscopic cholecystectomy without an autonomic neural blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative analgesic doses	acetaminophen 1g oral tablets	up to 72 hours
postoperative analgesic doses-rescue 1	Ibuprofen 400 mg oral tablets	up to 72 hours
postoperative analgesic doses-rescue 2	acetaminophen 300 mg plus codeine 8 mg oral tablets	up to 72 hours
postoperative analgesic-rescue 3	Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules	up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain level	Visual Analog Scale (VAS) scores will be recorded (0-10)	1, 24 and 48 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea	presence of nausea	1,8 and 24 hours after surgery
postoperative vomiting	presence of vomiting	1,8,24 hours after surgery

Collaborators and Investigators

• Sponsor: Universidad Simón Bolívar

Publications and helpful links

General Publications

• Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
• Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
• Daes J, Pauli E. Autonomic Neural Blockade in Minimally Invasive Surgery. JAMA Surg. 2024 Dec 1;159(12):1433-1434. doi: 10.1001/jamasurg.2024.2334.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 4, 2025

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: postoperative nausea; opioid use; Visceral pain; analgesic consumption; Postoperative vomiting; autonomic neural blockade,
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nociceptive Pain; Nausea; Vomiting; Postoperative Nausea and Vomiting; Visceral Pain
• Other Study ID Numbers: PRO-CEI-USB-CE-0394-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the raw data of the study( all IPD that underlie results in a publication) will be shared with the reviewers of the correspondent Journal
• IPD Sharing Time Frame: during the review process in the indicated Journal
• IPD Sharing Access Criteria: though the corresponding Journal"s editorial manager.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No