Intravenous Lidocaine for Hepatectomy

NCT07590830 | Not Yet Recruiting Phase 4

• 2 other identifiers: 35RC23_8878_ILHEP2025-522462-73-00
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Hepatectomy

Keywords

Lidocaine; Pain management; Analgesics; Postoperative opioid related-side effects; Double-Blind Method; Hepatectomy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (22)

• Determine the occurrence of postoperative opioid-related nausea and vomiting

  from Hour 0 to Hour 48

• Determine the occurrence of postoperative opioid-related hypoxemia

  from Hour 0 to Hour 48

• Determine the occurrence of postoperative opioid-related ileus

  from Hour 0 to Hour 48

• Determine the 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.

  from Hour 0 to Hour 48

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

Standard anaesthesia protocol with lidocaine

Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine

Control Group

PLACEBO COMPARATOR

Standard anaesthesia protocol with placebo (NaCl)

Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo

Interventions

Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine DRUG

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

Also known as: Lidocaine

Lidocaine Group

Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo DRUG

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

Also known as: Placebo

Control Group

Eligibility Criteria

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

You may not qualify if:

• 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
• Renal insufficiency (Creatinine clearance \< 15 mL/min)
• Untreated glaucoma
• Uncontrolled epilepsy
• Allergy
• Renal insufficiency (Creatinine clearance \< 50 mL/min)
• Inflammatory bowel disease
• Allergy

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (9)

Centre 03 - CHU de Clermont-Ferrand, Hôpital Estaing

Clermont-Ferrand, 63100, France

Location

Centre 04 - Centre Hospitalier Départemental de la Vendée

La Roche-sur-Yon, 85000, France

Location

Centre 02 - CH Louis Pasteur, Les Hôpitaux de Chartres

Le Coudray, 28630, France

Location

Centre 05 - CHU de Lille

Lille, 59000, France

Location

Centre 06 - Centre Léon Bérard

Lyon, 69008, France

Location

Centre 07 - CHU Nice, Hôpital Archet 2

Nice, 06200, France

Location

Centre 08 - AP-HP - Sorbonne Université, Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location

Centre 01 - CHU de RENNES, Hôpital Pontchaillou

Rennes, 35000, France

Location

Centre 09 - CHU Toulouse, Hôpital Rangueil

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Pr Hélène BELOEIL, MD

CONTACT

+33299282422; helene.beloeil@chu-rennes.fr

Alain CARO

CONTACT

+33299289496; alain.caro@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The ILHEP study is a multicenter, prospective, randomized, controlled double-blind study

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

FR (9)