Intraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery

NCT07012889 | Not Yet Recruiting

• 1 other identifier: KB/23/2025
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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

Keywords

postoperative pain; laparoscopic liver surgery; lidocaine infusion

Outcome Measures

Primary Outcomes (1)

• opioid consumption during the first 24 hours after the surgery

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

  First 24 hours after the end of the surgery (extubation)

Secondary Outcomes (2)

• 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

• HOMA-IR

  from the day 0 after surgery to day 3 after surgery

Study Arms (2)

The lidocaine group

EXPERIMENTAL

Drug: lidocaine infusion

The placebo group

PLACEBO COMPARATOR

Other: Placebo

Interventions

lidocaine infusion 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 lidocaine group

Placebo 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

The placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years old
• patients scheduled for laparoscopic liver surgery
• patients classified as American Society of Anesthesiology (ASA) physical status I- III

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Paula Dudek, MD

CONTACT

+48225992002; paula.dudek@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06