Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Postoperative Pain After Laparoscopic Liver Resection Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine infusion

Drug

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.

Placebo

Other

The placebo group will be administered normal saline 0.9% at the same volume, infusion rate and timing as lidocaine in the lidocaine group

Primary outcomes

opioid consumption during the first 24 hours after the surgery

Time frame: First 24 hours after the end of the surgery (extubation)

the mean cumulative opioid consumption during the first 24 hours after the surgery

Secondary outcomes

gut recovery

Time frame: from the end of the surgery (extubation) until the date of first documented flatus or stool, whichever came first, assessed up to 72 hours

time to first flatus or stool after surgery
HOMA-IR

Time frame: from the day 0 after surgery to day 3 after surgery

fasting blood glucose concentration, insulin levels preoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Dudek, MD

CONTACT

[email protected]

+48225992002

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Acronym: ICLIL

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 10, 2025
Registry last updated: Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting