Clinical trial NCT06753500: Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy
Official title: Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Visceral Pain
Analgesia
Opioid Use
Postoperative Nausea
Postoperative Vomiting
Keywords: autonomic neural blockade,
Visceral pain
postoperative nausea
Postoperative vomiting
analgesic consumption
opioid use
Lead sponsor: Universidad Simón Bolívar
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, parallel assignment, Double-Blind (Participant, Investigator), Preventive
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative analgesic doses
timeFrame: up to 72 hours
measure: postoperative analgesic doses-rescue 1
timeFrame: up to 72 hours
measure: postoperative analgesic doses-rescue 2
timeFrame: up to 72 hours
measure: postoperative analgesic-rescue 3
timeFrame: up to 72 hours
Secondary outcomes:
measure: pain level
timeFrame: 1, 24 and 48 hours after surgery
Other outcomes:
measure: postoperative nausea
timeFrame: 1,8 and 24 hours after surgery
measure: postoperative vomiting
timeFrame: 1,8,24 hours after surgery
Locations:
city: Barranquilla
country: Colombia
facility: clinica Iberoamerica
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica Portoazul
state: Atlantivo
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.