Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery (ICLIL)

Medical University of Warsaw

Status: Not yet enrolling

Conditions: Postoperative Pain After Laparoscopic Liver Resection

Treatments: Drug: lidocaine infusion; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07012889

KB/23/2025

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

The lidocaine group

Experimental group

Treatment:

Drug: lidocaine infusion

The placebo group

Placebo Comparator group

Treatment:

Other: Placebo