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Study on Lidocaine and Sodium Chloride for Patients Undergoing Liver Tumor Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing liver surgery due to liver tumors. The study is investigating the use of lidocaine, a local anesthetic, administered through an intravenous solution, to see if it can help improve recovery after surgery. The trial will also use sodium chloride, commonly known as saline, as part of the treatment process. The main goal is to evaluate how effective lidocaine is in helping patients recover from a minor liver surgery, known as a hepatectomy.

Participants in the study will receive either lidocaine or a placebo during their surgery. The study will monitor various aspects of recovery, such as the amount of pain medication needed in the first 24 to 48 hours after surgery, the intensity of pain experienced, and any complications that may arise. Other factors being observed include the time it takes for normal bowel movements to resume, any feelings of nausea or vomiting, and the overall length of the hospital stay.

The study will also measure the concentration of lidocaine in the blood at different times during the surgery and recovery process. The aim is to gather comprehensive data on how lidocaine affects recovery and to assess any potential side effects or adverse events. This information will help determine if lidocaine can be a beneficial addition to the recovery process for patients undergoing liver surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written consent. Eligibility requires being 18 years or older and scheduled for minor liver surgery.

  2. Step 2

    Pre-surgery preparation

    Before surgery, intravenous administration of lidocaine and sodium chloride is prepared. This involves setting up an intravenous line for medication delivery.

  3. Step 3

    Surgery and medication administration

    During surgery, lidocaine is administered intravenously. The goal is to assess its effectiveness in reducing pain and opioid use post-surgery.

  4. Step 4

    Post-surgery monitoring

    After surgery, monitoring includes measuring opioid consumption over the first 24 and 48 hours. Pain levels are assessed using a numerical rating scale.

    Blood samples are taken to measure lidocaine and MEGX concentrations at specific times: immediately after anesthesia induction, 30 minutes post-resection, and at the end of infusion.

  5. Step 5

    Recovery and follow-up

    Recovery involves tracking various factors such as time to first bowel movement, nausea, vomiting, and overall hospital stay length.

    Additional assessments include quality of recovery (QoR-40) and any adverse events. The study aims to complete by January 31, 2026.

Who can join the trial?

3 criteria

  • Must be **18 years or older**.
  • Must be a **patient scheduled for minor liver surgery**. This means a planned operation on the liver that is not extensive.
  • Must provide **written informed consent**. This means you agree to participate in the study after being fully informed about it and sign a document to confirm your agreement.

Who cannot join the trial?

1 criterion

  • Patients who have had surgery to remove liver tumors cannot participate.
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Investigated drugs

Lidocaine is a medication used in this trial to help with recovery after liver surgery. It is given through an IV (intravenous) to patients who have undergone a minor hepatectomy, which is a type of liver surgery. The main goal of using lidocaine in this study is to see how well it helps patients recover after their surgery.

What is already known about the treatment

Lidocaine – Lidocaine is administered intravenously and is currently being studied for its effectiveness in improving post-operative recovery in patients undergoing liver surgery. It is well-established in medical literature as a local anesthetic and antiarrhythmic agent. The main therapeutic indication in this trial is to aid recovery after liver surgery. At the molecular level, lidocaine works by blocking sodium channels, which helps to reduce pain and stabilize nerve activity. It is classified pharmacologically as a local anesthetic and antiarrhythmic medication.

Investigated diseases

Liver Tumors – Liver tumors are abnormal growths of tissue within the liver. They can be benign (non-cancerous) or malignant (cancerous), with the latter being more serious. Malignant liver tumors, such as hepatocellular carcinoma, often arise due to chronic liver diseases like hepatitis or cirrhosis. These tumors can grow and spread to other parts of the body if not managed. Symptoms may include abdominal pain, weight loss, and jaundice. The progression of liver tumors depends on various factors, including the type of tumor and underlying liver health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508173-90-00Estimated enrolment124 patientsSponsorRegion Skane

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