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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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%.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Ceoxrk Ltqe Byuzmf Lyon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.01.2026

Trial locations

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.

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 ID:
2025-522462-73-00
Protocol code:
35RC23_8878_ILHEP
Trial Phase:
Therapeutic confirmatory (Phase III)

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