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Study of lidocaine hydrochloride to reduce side effects from pain medication in patients undergoing open liver surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients undergoing an open hepatectomy, which is a major surgical procedure to remove a portion of the liver. The research aims to compare the effects of an infusion of lidocaine hydrochloride with a placebo on side effects caused by opioids, which are strong pain medications, following the surgery. Potential complications being monitored include postoperative nausea and vomiting, hypoxemia, which is a condition where there is not enough oxygen in the blood, and postoperative ileus, a temporary lack of normal muscle contractions in the intestines that prevents the passage of food or gas.

Participants in the study will receive either lidocaine hydrochloride or sodium chloride through an intravenous infusion, meaning the substance is delivered directly into a vein. The study period covers the time around the surgery and the first 48 hours after the breathing tube is removed. Various factors such as pain levels, the amount of pain medication used, the length of time spent in the hospital, and the risk of other issues like pneumonia or acute kidney insufficiency will be observed during the recovery process.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    During the surgery for open hepatectomy (a procedure to remove part of the liver), an intravenous infusion (medicine delivered directly into a vein) is provided.

    One group receives lidocaine hydrochloride at a dose of 1.50 mg/kg/h, while another group receives sodium chloride (a placebo, which is a substance with no active medicinal effect) at the same dose of 1.50 mg/kg/h.

  2. Step 2

    <b>postoperative monitoring</b>

    After the breathing tube is removed (extubation), pain levels are measured every 10 minutes while in the post-anesthesia care unit (the recovery area immediately after surgery).

    Following the initial recovery period, pain levels are assessed every 6 hours for up to 48 hours after the breathing tube is removed.

  3. Step 3

    <b>observation of side effects</b>

    For the first 48 hours after the breathing tube is removed, the occurrence of side effects related to opioid pain medication is monitored. these include nausea and vomiting, low blood oxygen levels (hypoxemia), and intestinal issues (ileus), such as an inability to tolerate food or an absence of gas and bowel movements.

    The need for anti-nausea medication and the duration of oxygen treatment are also recorded during this time.

  4. Step 4

    <b>extended monitoring and recovery</b>

    Over the next 7 days or until hospital discharge, observations are made regarding the occurrence of pneumonia (lung infection), acute kidney insufficiency (sudden loss of kidney function), surgical complications requiring further procedures, and atrial fibrillation (an irregular heartbeat).

    The total length of stay in the hospital, up to a maximum of 28 days, is tracked.

    Between 24 and 48 hours after the breathing tube is removed, the quality of recovery is measured.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older.
  • You must be scheduled to have an open hepatectomy, which is a type of major surgery to remove part or all of the liver through a large incision.
  • You must be using an effective method of contraception (methods used to prevent pregnancy) that follows the study guidelines.
  • You must receive oral and written information about the study and sign a consent form, which is a document where you officially agree to participate after understanding the details.
  • You must be covered by a social security scheme, which is a government or private insurance program that helps pay for medical costs.

Who cannot join the trial?

18 criteria

  • Weight greater than 100 kg.
  • Obstructive sleep apnoea syndrome, which is a condition where breathing repeatedly stops and starts during sleep.
  • Severe hepatic insufficiency, which means the liver is not working well enough, specifically measured by a Prothrombin Ratio (a blood test used to see how well your blood clots) of less than 15%.
  • Taking opioid medication (strong pain relief drugs) currently, as this could hide the true results of the study.
  • Being an adult under legal protection (such as having a legal guardian), being in prison, being pregnant or breast-feeding, being a minor (under 18), being unable to give consent (permission), or being in the hospital for a reason other than this surgery.
  • Participating in other interventional research studies.
  • Having an allergy or a medical reason not to use lidocaine (a medicine used to numb pain) or any of the ingredients used to make it.
  • Taking certain antiarrhythmic medications, which are drugs used to treat irregular heartbeats.
  • Having heart failure (specifically NYHA grade 3-4, which refers to severe symptoms during rest or light activity) or AV-block (an issue with the heart's electrical system) without a pacemaker.
  • Having acute porphyria, a group of rare genetic disorders that can cause skin or nerve problems.
  • Having uncontrolled epilepsy or seizures (sudden electrical disturbances in the brain) at the time of joining the study.
  • Having an allergy to any drugs or ingredients used during anaesthesia (the medicine used to make you sleep during surgery).
  • Having a medical reason not to take Nefopam (a type of pain medication), such as renal insufficiency (kidney problems measured by a creatinine clearance of less than 50 mL/min), inflammatory bowel disease (conditions that cause swelling in the digestive tract), or an allergy.
  • Having a medical reason not to take Ketoprofen (a type of pain medication), such as untreated glaucoma (increased pressure in the eye), uncontrolled epilepsy, or an allergy.
  • Needing urgent surgery.
  • Undergoing transplant surgery or being a patient who has already had an organ transplant.
  • Having a surgery where regional anaesthesia (numbing only a specific part of the body) is planned.
  • Having a preoperative SpO2 (blood oxygen level measured before surgery) of less than 95%.
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Investigated drugs

Lidocaine is a medication given through a vein during and around the time of surgery to see if it can help reduce the side effects caused by pain relief medicines (opioids) after a liver surgery.

What is already known about the treatment

  • SODIUM CHLORIDE

    This substance is administered through a direct injection or a slow drip into a vein and is commonly used in medical settings as a neutral placebo. It is a simple salt solution that is widely recognized and used to balance fluids in the body without having a specific medicinal effect for treating pain. In this study, it serves as a control to compare against the active test medication.

  • LIDOCAINE HYDROCHLORIDE

    This medication is given through an injection or a slow drip into a vein and is widely used in medicine to manage pain and stabilize heart rhythms. It works by blocking specific signals in the nerves that send pain messages to the brain, effectively numbing the area or reducing the sensation of discomfort. This drug belongs to a group called local anesthetics and is being studied here to see if it can help reduce side effects from other pain medicines after surgery.

Investigated diseases

Postanesthetic complications - These are various adverse medical issues that occur during the recovery period following the administration of anesthesia. They can manifest as digestive disturbances, breathing difficulties, or heart rhythm changes. The condition typically develops shortly after a patient wakes up from surgery. These effects may be triggered by the medications used during or after the surgical procedure. The symptoms vary depending on how the individual's body reacts to the anesthetic agents.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522462-73-00Protocol code35RC23_8878_ILHEPEstimated enrolment312 patientsSponsorCentre Hospitalier Universitaire De Rennes

sourced from the EU Clinical Trials Register and site verification

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