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Intravenous Lidocaine for Hepatectomy (ILHEP)

12 de mayo de 2026 actualizado por: Rennes University Hospital

Effect of Perioperative Intravenous Lidocaine on Postoperative Opioid Related-side Effects After Open HEPatectomy: a Multicentre Prospective Randomized Controlled Study

Liver resection is increasingly performed for hepatic tumors, mainly primary liver cancers and resectable metastases, but also for some benign lesions. Postoperative pain is often significant, regardless of the surgical technique, making effective pain control essential to promote early mobilization and reduce complications.

Current standard care relies on multimodal analgesia, combining several drugs administered during surgery, with morphine administered as rescue therapy when required. Morphine is associated with side effects such as nausea, vomiting, ileus, hypoxemia, opioid-induced hyperalgesia, and transient cognitive impairment. Therefore, there is a need to optimize pain management while reducing opioid consumption and related adverse effects.

Intravenous (IV) lidocaine has well-documented anti-inflammatory effects and is effective against neuropathic pain. Several studies have shown that intravenous lidocaine may be associated with improved analgesia, reduced opioid consumption, shorter hospital stay, and decreased postoperative ileus, nausea, and vomiting-particularly in abdominal and genitourinary surgeries. Therefore, Intravenous (IV) lidocaine may be a valuable alternative for postoperative pain management after liver surgery.

National guidelines now recommend perioperative Intravenous (IV) lidocaine for abdominal surgeries but its efficacy in liver surgery has not yet been established due to a lack of specific evidence (more specific data are needed). Findings from other types of abdominal surgery suggest a potential benefit, which should be confirmed by dedicated clinical trials and robust multicenter evaluation such as the ILHEP protocol.

The goal of this clinical trial is to assess the effect of intravenous perioperative lidocaine on postoperative opioid related-side effects and to formally confirm the safety of lidocaine during hepatic surgical procedures. The hypothesis is that Intravenous (IV) lidocaine compared with placebo (a look-alike substance that contains no drug e.g. a saline solution) would improve postoperative outcome by reducing opioid related side-effects in patients undergoing liver surgery and benefitting of the same baseline analgesia.

In the context of this trial, patients will receive either intravenous lidocaine or placebo according to their assigned randomization group during standardized general anesthesia, and will then be followed throughout their hospital stay until discharge or up to a maximum of 28 days.

An ancillary study will be conducted in patients enrolled at the coordinating center in Rennes to assess exposure to lidocaine during intravenous administration and to evaluate the relationship between blood concentrations and adverse events.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Patients scheduled for surgery under general anesthesia meeting the inclusion criteria will be eligible. During the preoperative anesthesia consultation (from Day-30 to Day-1), the investigator will present the study and the objectives of the research to the patient. When the patient arrives for admission, on the same day as the experimental visit or the day before (from Day-1 or Day 0), the investigator will verify the inclusion criteria and collect the written informed consent. Once inclusion has been validated, data will be collected : Socio-demographic data / Clinical data / List of chronic medications prior to surgery.

After signing the consent form and before the first dose of medication is taken, participants will be randomized into the control (placebo) or experimental group (lidocaine). In order to ensure group compatibility, a plan of randomization will be used : patients will be assigned to the treatment group in chronological order of randomization numbers, using a centralized randomization method via Ennov software (Ennov Clinical, Groupe Ennov, Paris, France). Randomization will be carried out online by investigators as close as possible to the surgery (Day-1 or Day 0). Participants and investigators will be blinded to the intervention.

Regarding the surgical procedure, general anesthesia will be standardized, and patients will receive either placebo or lidocaine according to the group to which they were assigned during randomization.

Physicians will be warned to reinject sufentanil or remifentanil during surgery in an opioid sparing spirit.

The postoperative protocol will be standardized. Extubation defines the Hour 0 for assessment of the primary criterion events. Aside from the placebo or lidocaine administered according to their randomization group, all patients will receive standard postoperative treatment.

An ancillary study will be conducted at the coordinating centre and is expected to include approximately 20 patients to assess drug exposure during perioperative intravenous lidocaine administration. It will also evaluate the relationship between maximal total and free concentrations (Cmax and Cmaxμ, measured at the end of the intravenous lidocaine bolus) and/or steady-state concentrations (Css and Cssμ, measured at the end of lidocaine administration) and the occurrence of adverse events. Blood samples (5 mL) will be drawn through a catheter:

  • 5 minutes after the lidocaine or placebo bolus
  • at the end of the lidocaine or placebo administration in post anesthesia care unit (PACU)

This trial is an intention to treat study, that is all randomized patients will be analyzed in their randomization group.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

312

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Francia
      • Clermont-Ferrand, Francia, 63100
        • Centre 03 - CHU de Clermont-Ferrand, Hôpital Estaing
        • Contacto:
        • Investigador principal:
          • Ugo SCHIFF, MD
      • La Roche-sur-Yon, Francia, 85000
        • Centre 04 - Centre Hospitalier Départemental de la Vendée
        • Contacto:
        • Investigador principal:
          • Alexis DUCHALAIS, MD
      • Le Coudray, Francia, 28630
        • Centre 02 - CH Louis Pasteur, Les Hôpitaux de Chartres
        • Contacto:
        • Investigador principal:
          • Nidhal CHEBBI, MD
      • Lille, Francia, 59000
        • Centre 05 - CHU de Lille
        • Investigador principal:
          • Gilles LEBUFFE, MD
        • Contacto:
      • Lyon, Francia, 69008
        • Centre 06 - Centre Léon Bérard
        • Contacto:
        • Investigador principal:
          • Grégoire WALLON, MD
      • Nice, Francia, 06200
        • Centre 07 - CHU Nice, Hôpital Archet 2
        • Contacto:
        • Investigador principal:
          • Romain ROZIER, MD
      • Paris, Francia, 75013
        • Centre 08 - AP-HP - Sorbonne Université, Hôpital de la Pitié-Salpêtrière
        • Contacto:
        • Investigador principal:
          • Alexandre SITBON, MD
      • Rennes, Francia, 35000
        • Centre 01 - CHU de RENNES, Hôpital Pontchaillou
        • Contacto:
        • Investigador principal:
          • Pr Hélène BELOEIL, MD
      • Toulouse, Francia, 31400
        • Centre 09 - CHU Toulouse, Hôpital Rangueil
        • Contacto:
        • Investigador principal:
          • Guillaume PORTA BONETE, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Inclusion criterion 1 : Age ≥ 18 years
  • Inclusion criterion 2 : Undergoing a scheduled surgery for open hepatectomy
  • Inclusion criterion 3 : Effective contraception in accordance with CFTG recommendations
  • Inclusion criterion 4 : Having received oral and written information about the protocol and having signed a consent form to take part in this research
  • Inclusion criterion 5 : Affiliated to a social security scheme

Exclusion Criteria:

  • Exclusion criterion 1 : Weight > 100 kg

  • Exclusion criterion 2 : Allergy or contraindication to lidocaine or one of its excipients and, in particular:

    • Known hypersensitivity to lidocaine hydrochloride, to amide-type local anesthetics, or to any of the excipients (sodium chloride, sodium hydroxide solution or concentrated hydrochloric acid solution, water for injection)
    • Treatment with following antiarythmic medication : class I, class III or Sotalol
    • Heart failure NYHA grade 3-4, AV-block >1, without pacemaker
    • Acute porphyria
    • Recurrent porphyrias
    • Uncontrolled epilepsy / Seizure at enrollment
  • Exclusion criterion 3 : Allergy to one of the drugs used for anaesthesia or one of their excipients

  • Exclusion criterion 4 : Nefopam contraindication and, in particular:

    • Renal insufficiency (Creatinine clearance < 15 mL/min)
    • Untreated glaucoma
    • Uncontrolled epilepsy
    • Allergy

  • Exclusion criterion 5 : Ketoprofen contraindication and, in particular:

    • Renal insufficiency (Creatinine clearance < 50 mL/min)
    • Inflammatory bowel disease
    • Allergy
  • Exclusion criterion 6 : Urgent surgery
  • Exclusion criterion 7 : Transplant surgery or transplanted patients
  • Exclusion criterion 8 : Surgery with planned regional anaesthesia
  • Exclusion criterion 9 : Patient with a preoperative Sp02 < 95%
  • Exclusion criterion 10 : Obstructive sleep apnea syndrome
  • Exclusion criterion 11 : Severe hepatic insufficiency (Prothrombin Ratio < 15%)
  • Exclusion criterion 12 : Patient with an ongoing opioid medication that will blur the results
  • Exclusion criterion 13 : Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breast-feeding women, minors, persons unable to express their consent, persons hospitalized for a different reason
  • Exclusion criterion 14 : Known participation in other interventional research (RIPH1 or RIPH2)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lidocaine Group
Standard anaesthesia protocol with lidocaine
Droga: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine
Standard general anaesthesia induction protocol with pre-defined bolus of lidocaine and standard general anaesthesia maintenance protocol with pre-defined continuous intravenous infusion of lidocaine
Otros nombres:
  • Lidocaína
Comparador de placebos: Control Group
Standard anaesthesia protocol with placebo (NaCl)
Droga: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo
Standard general anaesthesia induction protocol with pre-defined bolus of placebo and standard general anaesthesia maintenance protocol with pre-defined continuous intravenous infusion of placebo
Otros nombres:
  • Placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To compare the effects of a perioperative lidocaine infusion versus placebo on the composite incidence of postoperative opioid-related adverse events, assessed blinded to the randomization group, in patients undergoing open hepatectomy.
Periodo de tiempo: from Hour 0 (extubation) to Hour 48
Number of participants with at least one of the following postoperative opioid-related adverse events : Postoperative nausea and vomiting defined as any nausea or vomiting ; Postoperative hypoxemia defined as SpO2 < 95% with a need for oxygen supplementation ; Postoperative ileus duration. Ileus is defined as an intolerance to an oral diet (e.g. soft food or light meal)
from Hour 0 (extubation) to Hour 48

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Determine the occurrence of postoperative opioid-related nausea and vomiting
Periodo de tiempo: from Hour 0 to Hour 48
Occurrence of postoperative opioid-related nausea and vomiting (the need for anti-emetic medication will also be recorded)
from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related hypoxemia
Periodo de tiempo: from Hour 0 to Hour 48
Occurrence of postoperative opioid-related hypoxemia (duration of oxygen treatment will also be recorded)
from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related ileus
Periodo de tiempo: from Hour 0 to Hour 48
Occurrence of postoperative opioid-related ileus
from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related absence of flatus or stools
Periodo de tiempo: from Hour 0 to Hour 48
Occurrence of postoperative opioid-related absence of flatus or stools
from Hour 0 to Hour 48
Determine if lidocaine is associated with a better postoperative analgesia at rest, as measured by the number of episodes with a Numeric Rating Scale score > 3, recorded every 10 minutes during post anesthesia care unit stay and every 6 hours thereafter.
Periodo de tiempo: from Hour 0 to Hour 48
Number of episodes with Numeric Rating Scale score > 3 at rest Numeric rating scale : Zero is equivalent to no pain and 10 indicates the worst possible pain.
from Hour 0 to Hour 48
Determine if lidocaine is associated with a better postoperative analgesia at rest, as measured by the maximum Numeric Rating Scale score recorded.
Periodo de tiempo: from Hour 0 to Hour 48
Maximum Numeric rating scale score recorded at rest Numeric rating scale : Zero is equivalent to no pain and 10 indicates the worst possible pain.
from Hour 0 to Hour 48
Determine if lidocaine is associated with a better postoperative analgesia during movement, as measured by the number of episodes with a NRS score > 3, recorded every 10 minutes during Post-Anesthesia Care Unit stay and every 6 hours thereafter
Periodo de tiempo: from Hour 0 to Hour 48
Number of episodes with Numeric rating scale > 3 during movement Numeric rating scale : Zero is equivalent to no pain and 10 indicates the worst possible pain.
from Hour 0 to Hour 48
Determine if lidocaine is associated with a better postoperative analgesia during movement, as measured by the maximum Numeric Rating Scale score recorded.
Periodo de tiempo: from Hour 0 to Hour 48
Maximum Numeric rating scale score recorded during movement Numeric rating scale : Zero is equivalent to no pain and 10 indicates the worst possible pain.
from Hour 0 to Hour 48
Determine if lidocaine can reduce postoperative opioid consumption
Periodo de tiempo: from Hour 0 to Hour 48
Opioid consumption (mg)
from Hour 0 to Hour 48
Determine if lidocaine can reduce the delay to obtain an Aldrete score ≥ 9 after extubation
Periodo de tiempo: from Hour 0 (extubation) to Post-Anesthesia Care Unit discharge, up to 24 hours

Time (minutes) between extubation (H0) and achieving an Aldrete score ≥ 9 Aldrete Scoring System consists of 5 clinically relevant parameters reflecting physiological recovery from anesthesia (muscle activity, respiration, circulation, consciousness, and color) ranging from 0 (no recovery) to 10 (full recovery).

A total score of 0 indicates no recovery across the assessed criteria and reflects the poorest possible post-anesthesia status. A total score of 10 indicates full recovery across all assessed criteria, represents the best possible post-anesthesia status and is generally ready for discharge from the post-anesthesia care unit.
from Hour 0 (extubation) to Post-Anesthesia Care Unit discharge, up to 24 hours
Determine if lidocaine reduces postoperative rate of unscheduled admission in intensive care unit (ICU)
Periodo de tiempo: from Hour 0 to Day 28
Rate of unscheduled admission in intensive care unit
from Hour 0 to Day 28
Determine if lidocaine reduces the length of stay in the hospital
Periodo de tiempo: from Hour 0 to Day 28
Hospital length of stay (minutes)
from Hour 0 to Day 28
Determine if lidocaine reduces the incidence of the most frequent complications, particularly pneumonia
Periodo de tiempo: from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Occurrence of pneumonia episodes of newly confirmed pneumonia according to the modified Centers for Disease Control and Prevention (CDC) criteria.
from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Determine if lidocaine reduces the incidence of the most frequent complications, particularly acute kidney injury
Periodo de tiempo: from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Occurrence of acute kidney insufficiency defined with Kidney Disease Improving Global Outcomes (KDIGO) ≥ 2
from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Determine if lidocaine reduces the incidence of the most frequent complications, particularly the need for reintervention because of a surgical complication
Periodo de tiempo: from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Occurrence of reintervention because of surgical complication
from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Determine if lidocaine reduces the incidence of the most frequent complications, particularly new onset of postoperative atrial fibrillation
Periodo de tiempo: from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Occurrence of a new onset of postoperative atrial fibrillation
from Hour 0 to Day 7 or until hospital discharge, whichever occurs first; maximum Day 28
Determine if lidocaine is associated with a better quality of recovery
Periodo de tiempo: from Hour 24 to Hour 48
Quality of recovery questionnaire QoR-40 is a 40-item questionnaire used to assess postoperative quality of recovery : the total score ranges from 40 (the worst possible recovery) to 200 (the best possible recovery).
from Hour 24 to Hour 48
Monitore the adverse effects of intravenous lidocaine
Periodo de tiempo: from Hour 0 to Hour 24
Number of adverse effects of intravenous experimental treatment
from Hour 0 to Hour 24
Evaluate drug exposure in 20 patients included in the coordinating center : relationship between maximal total plasma lidocaine concentration and the occurrence of adverse events
Periodo de tiempo: Perioperative/Periprocedural (5 minutes after the end of the IV lidocaine bolus)
Maximal total plasma lidocaine concentrations : Cmax , measured 5 minutes after the end of the IV lidocaine bolus
Perioperative/Periprocedural (5 minutes after the end of the IV lidocaine bolus)
Evaluate drug exposure in 20 patients included in the coordinating center : relationship between maximal free plasma lidocaine concentration and the occurrence of adverse events
Periodo de tiempo: Perioperative/Periprocedural (5 minutes after the end of the IV lidocaine bolus)
Maximal free plasma lidocaine concentrations : Cmaxμ, measured 5 minutes after the end of the IV lidocaine bolus
Perioperative/Periprocedural (5 minutes after the end of the IV lidocaine bolus)
Evaluate drug exposure in 20 patients included in the coordinating center : relationship between steady-state total plasma lidocaine concentration and the occurrence of adverse events
Periodo de tiempo: Day 0 (at the end of IV continuous lidocaine administration)
Steady-state total plasma lidocaine concentration : Css, measured at the end of IV continuous lidocaine administration
Day 0 (at the end of IV continuous lidocaine administration)
Evaluate drug exposure in 20 patients included in the coordinating center : relationship between steady-state free plasma lidocaine concentration and the occurrence of adverse events
Periodo de tiempo: Day 0 (at the end of IV continuous lidocaine administration)
Steady-state free plasma lidocaine concentration : Cssµ, measured at the end of IV continuous lidocaine administration
Day 0 (at the end of IV continuous lidocaine administration)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Rennes University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de septiembre de 2028

Finalización del estudio (Estimado)

1 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 35RC23_8878_ILHEP
  • 2025-522462-73-00 (Ctis)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Undecided

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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