Health TrialsbyHealthPanel

Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy

ConditionsVisceral PainAnalgesiaOpioid UsePostoperative NauseaPostoperative Vomiting
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Simón Bolívar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective or emergency laparoscopic cholecystectomy for cholelithiasis with or without cholecystitis.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autonomic neural blockade

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Autonomic Neural BlockadeExperimental treatment 1 intervention
Group B: NO BLOCKADENo intervention 0 interventions

Trial outcomes

Primary outcomes

1

postoperative analgesic doses

acetaminophen 1g oral tablets

Time frame
up to 72 hours
2

postoperative analgesic doses-rescue 1

Ibuprofen 400 mg oral tablets

Time frame
up to 72 hours
3

postoperative analgesic doses-rescue 2

acetaminophen 300 mg plus codeine 8 mg oral tablets

Time frame
up to 72 hours
4

postoperative analgesic-rescue 3

Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules

Time frame
up to 72 hours

Secondary outcomes

1

pain level

Visual Analog Scale (VAS) scores will be recorded (0-10)

Time frame
1, 24 and 48 hours after surgery

Other outcomes

1

postoperative nausea

presence of nausea

Time frame
1,8 and 24 hours after surgery
2

postoperative vomiting

presence of vomiting

Time frame
1,8,24 hours after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Simón Bolívar

Lead sponsor

Source ClinicalTrials.gov
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