Autonomic neural blockade
ProcedureAutonomic nerve block performed with:
- Bupivacaine: 20 mL of 0.5%.
- Dexamethasone: 8 mg.
Other names: BLOCKADE
NCT Number: NCT06753500
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Clinica Portoazul, Barranquilla, Atlantivo, Colombia
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Autonomic nerve block performed with:
Other names: BLOCKADE
Time frame: up to 72 hours
acetaminophen 1g oral tablets
Time frame: up to 72 hours
Ibuprofen 400 mg oral tablets
Time frame: up to 72 hours
acetaminophen 300 mg plus codeine 8 mg oral tablets
Time frame: up to 72 hours
Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules
Time frame: 1, 24 and 48 hours after surgery
Visual Analog Scale (VAS) scores will be recorded (0-10)
Time frame: 1,8 and 24 hours after surgery
presence of nausea
Time frame: 1,8,24 hours after surgery
presence of vomiting
Contact information is provided by the study sponsor or research team.
Andres Hanssen, MD
CONTACT
Jorge Daes, MD
CONTACT
Universidad Simón Bolívar
Other
Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial
Acronym: ANB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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