Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain After Laparoscopic Liver Resection
• Interventions: Drug: lidocaine infusion; Other: Placebo

• Registration Number: NCT07012889
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-23
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2027-03-02
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The lidocaine group	lidocaine infusion	-
The placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
opioid consumption during the first 24 hours after the surgery	First 24 hours after the end of the surgery (extubation)	the mean cumulative opioid consumption during the first 24 hours after the surgery

Secondary Outcome Measures

Name	Time	Method
HOMA-IR	from the day 0 after surgery to day 3 after surgery	fasting blood glucose concentration, insulin levels preoperatively
gut recovery	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