Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery

NCT ID: NCT07012889

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-05-30

Brief Summary

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.

Conditions

Postoperative Pain After Laparoscopic Liver Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

The lidocaine group

Group Type: EXPERIMENTAL

lidocaine infusion

Intervention Type: 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.

The placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Paula Dudek, MD

Role: CONTACT

paula.dudek@wum.edu.pl

+48225992002

Other Identifiers

KB/23/2025

Identifier Type: -

Identifier Source: org_study_id