Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

NCT06753500 | Recruiting Phase 4

• 1 other identifier: PRO-CEI-USB-CE-0394-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Visceral Pain; Analgesia; Opioid Use; Postoperative Nausea; Postoperative Vomiting

Keywords

autonomic neural blockade,; Visceral pain; postoperative nausea; Postoperative vomiting; analgesic consumption; opioid use

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• pain level

  1, 24 and 48 hours after surgery

Other Outcomes (2)

• postoperative nausea

  1,8 and 24 hours after surgery

• postoperative vomiting

  1,8,24 hours after surgery

Study Arms (2)

Autonomic Neural Blockade

EXPERIMENTAL

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

NO BLOCKADE

NO INTERVENTION

Patients will undergo a laparoscopic cholecystectomy without an autonomic neural blockade

Interventions

Autonomic neural blockade PROCEDURE

Autonomic nerve block performed with: * Bupivacaine: 20 mL of 0.5%. * Dexamethasone: 8 mg.

Also known as: BLOCKADE

Autonomic Neural Blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Simón Bolívar: lead

Study Sites (2)

Clinica Portoazul

Barranquilla, Atlantivo, 080020, Colombia

RECRUITING

clinica Iberoamerica

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Related Publications (4)

• 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.

  PMID: 36050617 RESULT

• 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.

  PMID: 38091501 RESULT

• 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.

  PMID: 39382864 RESULT

• Daes J, Hanssen A, Luque E, Mercado J, De la Rosa DG, Pauli EM. Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial. Surg Endosc. 2026 Jan 13. doi: 10.1007/s00464-025-12542-2. Online ahead of print.

  PMID: 41530355 DERIVED

MeSH Terms

Conditions

Visceral Pain; Agnosia; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Central Study Contacts

Jorge Daes, MD

CONTACT

+573106363636; jorgedaez@gmail.com

Andres Hanssen, MD

CONTACT

+573123012321; anhanssen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be conducted using sealed envelopes stratified by the institution in blocks of six. The data manager will prepare and store the randomization list, and only they will have access to it during the study. The sealed envelopes will be placed in the patient's medical record and opened only when the patient is in the operating room and general anesthesia has been initiated. Both the patient and the independent investigator evaluating the data will remain blinded to the treatment group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, parallel assignment, Double-Blind (Participant, Investigator), Preventive

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: January 15, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 4, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: during the review process in the indicated Journal
• Access Criteria: though the corresponding Journal"s editorial manager.

Locations

CO (2)