Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery

N/ANot Yet RecruitingNCT07012889

Medical University of Warsaw94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain After Laparoscopic Liver Resection

Interventions

lidocaine infusionDRUG

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.

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

opioid consumption during the first 24 hours after the surgery

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

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

Secondary Outcomes

gut recovery

time to first flatus or stool after surgery

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

HOMA-IR

fasting blood glucose concentration, insulin levels preoperatively

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