Clinical trial NCT07012889: Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery
Official title: Safety and Efficacy of Intraoperative Continuous Lidocaine Infusion in Patients Undergoing Laparoscopic Liver Surgery: Effects on Postoperative Pain, Gut Function and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain After Laparoscopic Liver Resection
Keywords: postoperative pain
laparoscopic liver surgery
lidocaine infusion
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: opioid consumption during the first 24 hours after the surgery
timeFrame: First 24 hours after the end of the surgery (extubation)
Secondary outcomes:
measure: gut recovery
timeFrame: from the end of the surgery (extubation) until the date of first documented flatus or stool, whichever came first, assessed up to 72 hours
measure: HOMA-IR
timeFrame: from the day 0 after surgery to day 3 after surgery
Other outcomes:
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