Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery (ICLIL)

Safety and Efficacy of Intraoperative Continuous Lidocaine Infusion in Patients Undergoing Laparoscopic Liver Surgery: Effects on Postoperative Pain, Gut Function and Insulin Resistance

The goal of this clinical trial is to learn about effect of intraoperative continuous lidocaine infusion on postoperative pain, gut function and insulin resistance in patients undergoing laparoscopic liver surgery in adults. It will also learn about the safety of this infusion in this setting. The main questions it aims to answer are: does the intraoperative continuous systemic lidocaine infusion lower the opioid consumption 24h after surgery? Is the time to first flatus after surgery reduced? Is there increases in insulin resistance after intraoperative lidocaine infusion? Researchers will compare intraoperative continuous systemic lidocaine infusion to a placebo (a look-alike substance that contains no drug, which will be normal saline administered at the same volume, infusion rate and timing) to see if intraoperative continuous systemic lidocaine infusion reduces postoperative pain after laparoscopic liver resection.

Participants will receive intraoperative continuous systemic lidocaine infusion or placebo. Clinical assessment will be based on gathering data of NRS scores after the surgery, time to first flatus or stool. How much opioids the patients need in the first 3 postoperative days. Laboratory assessment will include the evaluation of fasting blood glucose concentration and insulin levels preoperatively and on 1, 2 and 3 postoperative days.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain After Laparoscopic Liver Resection
• Intervention / Treatment: Drug: lidocaine infusion; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paula Dudek, MD; Phone Number: +48225992002; Email: paula.dudek@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age >18 years old
• patients scheduled for laparoscopic liver surgery
• patients classified as American Society of Anesthesiology (ASA) physical status I- III

Exclusion Criteria:

• medical history of seizure disorders
• allergy to Lidocaine
• cardiac rhythm disorders (e.g. sick sinus syndrome, Adams-Stockes syndrome, II- and III-degree AV blocks, double- bundle branch block, HR < 50/min)
• systolic heart failure (ejection fraction <50%)
• hepatic dysfunction (aspartate aminotransferase or alanine transaminase or total bilirubin >2.5 times the upper limit of normal)
• renal impairment (GFR < 50ml/min/1.73 m2)
• weight less than 45 kg, BMI > 30
• metastases occurring in other distant organs
• recent use of any analgesic medication within 48h before surgery
• history of alcohol or substance abuse
• chronic pain syndrome
• chronic opioid use
• inability to comprehend NRS or complete questionnaires due to language barrier or cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: The placebo group	Other: Placebo; The placebo group will be administered normal saline 0.9% at the same volume, infusion rate and timing as lidocaine in the lidocaine group
Experimental: The lidocaine group	Drug: lidocaine infusion; The lidocaine group will receive initial intravenous bolus dose of 1.5mg/kg lidocaine over 10 min, followed by a continuous infusion of 1.5 mg/kg/h lidocaine until the end of surgery. The dose of lidocaine will be calculated according to ideal body weight. The placebo group will be administered normal saline at the same volume, infusion rate and timing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption during the first 24 hours after the surgery	the mean cumulative opioid consumption during the first 24 hours after the surgery	First 24 hours after the end of the surgery (extubation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gut recovery	time to first flatus or stool after surgery	from the end of the surgery (extubation) until the date of first documented flatus or stool, whichever came first, assessed up to 72 hours
HOMA-IR	fasting blood glucose concentration, insulin levels preoperatively	from the day 0 after surgery to day 3 after surgery

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: June 4, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: postoperative pain; lidocaine infusion; laparoscopic liver surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: KB/23/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No