Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-11-04

Brief Summary

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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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Detailed Description

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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.

Conditions

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Visceral Pain Analgesia Opioid Use Postoperative Nausea Postoperative Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Autonomic neural blockade

Intervention Type PROCEDURE

Autonomic nerve block performed with:

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

NO BLOCKADE

Patients will undergo a laparoscopic cholecystectomy without an autonomic neural blockade

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Autonomic neural blockade

Autonomic nerve block performed with:

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

Intervention Type PROCEDURE

Other Intervention Names

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BLOCKADE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No