Skip to content

Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06753500
Acronym
ANB
Enrollment
60
Registered
2024-12-31
Start date
2025-01-15
Completion date
2025-11-04
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDUREAutonomic neural blockade

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

Sponsors

Universidad Simón Bolívar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative analgesic dosesup to 72 hoursacetaminophen 1g oral tablets
postoperative analgesic doses-rescue 1up to 72 hoursIbuprofen 400 mg oral tablets
postoperative analgesic doses-rescue 2up to 72 hoursacetaminophen 300 mg plus codeine 8 mg oral tablets
postoperative analgesic-rescue 3up to 72 hoursKetorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules

Secondary

MeasureTime frameDescription
pain level1, 24 and 48 hours after surgeryVisual Analog Scale (VAS) scores will be recorded (0-10)

Other

MeasureTime frameDescription
postoperative vomiting1,8,24 hours after surgerypresence of vomiting
postoperative nausea1,8 and 24 hours after surgerypresence of nausea

Countries

Colombia

Contacts

Primary ContactJorge Daes, MD
jorgedaez@gmail.com+573106363636
Backup ContactAndres Hanssen, MD
anhanssen@gmail.com+573123012321

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026