Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

Phase 4

Recruiting

• Conditions: Visceral Pain; Analgesia; Opioid Use; Postoperative Nausea; Postoperative Vomiting

• Registration Number: NCT06753500
• Lead Sponsor: Universidad Simón Bolívar

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-21
• Study First Posted: 2024-12-31
• Study Start: 2025-01-15
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

clinica Iberoamerica; 🇨🇴 Barranquilla, Atlantico, Colombia

Clinica Portoazul; 🇨🇴 Barranquilla, Atlantivo, Colombia