HepatectomyPhase 4ILHEPNCT07590830
Intravenous Lidocaine for Hepatectomy
A Phase 4 study testing Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine in people with Hepatectomy, run by Rennes University Hospital at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 9 sitesFrance
- Study dates
- 1 Aug 2026to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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 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 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)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites
Centre 03 - CHU de Clermont-Ferrand, Hôpital Estaing
Clermont-Ferrand, 63100
Ugo SCHIFF, MD, +33473755168, uschiff@chu-clermontferrand.fr
Ugo SCHIFF, MD
Centre 04 - Centre Hospitalier Départemental de la Vendée
La Roche-sur-Yon, 85000
Alexis DUCHALAIS, MD, +33251446237, alexis.duchalais@ght85.fr
Alexis DUCHALAIS, MD
Centre 02 - CH Louis Pasteur, Les Hôpitaux de Chartres
Le Coudray, 28630
Nidhal CHEBBI, MD, +33237303030, nchebbi@ch-chartres.fr
Nidhal CHEBBI, MD
Centre 05 - CHU de Lille
Lille, 59000
Gilles LEBUFFE, MD, +330320444508, gilles.lebuffe@chru-lille.fr
Gilles LEBUFFE, MD
Centre 06 - Centre Léon Bérard
Lyon, 69008
Grégoire WALLON, MD, +33478782971, gregoire.wallon@lyon.unicancer.fr
Grégoire WALLON, MD
Centre 07 - CHU Nice, Hôpital Archet 2
Nice, 06200
Romain ROZIER, MD, +33492036647, rozier.r@chu-nice.fr
Romain ROZIER, MD
Centre 08 - AP-HP - Sorbonne Université, Hôpital de la Pitié-Salpêtrière
Paris, 75013
Alexandre SITBON, MD, +33184827379, alexandre.sitbon@aphp.fr
Alexandre SITBON, MD
Centre 01 - CHU de RENNES, Hôpital Pontchaillou
Rennes, 35000
Pr Hélène BELOEIL, MD, +33299282422, helene.beloeil@chu-rennes.fr
Pr Hélène BELOEIL, MD
Centre 09 - CHU Toulouse, Hôpital Rangueil
Toulouse, 31400
Guillaume PORTA BONETE, MD, +33561323565, porta-bonete.g@chu-toulouse.fr
Guillaume PORTA BONETE, MD
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hepatectomy
- Being tested
- Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine, Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo
- Keywords
- Lidocaine, Pain management, Analgesics, Postoperative opioid related-side effects, Double-Blind Method, Hepatectomy, Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous LidocaineDrug
Also called 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
Standardized General Anesthesia Induction and Maintenance Protocol incorporating PlaceboDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Standard anaesthesia protocol with lidocaine Receives: Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine |
| Control Group | Placebo comparator | Standard anaesthesia protocol with placebo (NaCl) Receives: Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from Hour 0 (extubation) to Hour 48
Secondary outcomes (22)
Determine the occurrence of postoperative opioid-related nausea and vomiting
Occurrence of postoperative opioid-related nausea and vomiting (the need for anti-emetic medication will also be recorded)
Measured: from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related hypoxemia
Occurrence of postoperative opioid-related hypoxemia (duration of oxygen treatment will also be recorded)
Measured: from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related ileus
Occurrence of postoperative opioid-related ileus
Measured: from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related absence of flatus or stools
Occurrence of postoperative opioid-related absence of flatus or stools
Measured: 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.
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.
Measured: 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.
Maximum Numeric rating scale score recorded at rest Numeric rating scale : Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: 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
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.
Measured: 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.
Maximum Numeric rating scale score recorded during movement Numeric rating scale : Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: from Hour 0 to Hour 48
Determine if lidocaine can reduce postoperative opioid consumption
Opioid consumption (mg)
Measured: from Hour 0 to Hour 48
Determine if lidocaine can reduce the delay to obtain an Aldrete score ≥ 9 after extubation
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.
Measured: 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)
Rate of unscheduled admission in intensive care unit
Measured: from Hour 0 to Day 28
Determine if lidocaine reduces the length of stay in the hospital
Hospital length of stay (minutes)
Measured: from Hour 0 to Day 28
Determine if lidocaine reduces the incidence of the most frequent complications, particularly pneumonia
Occurrence of pneumonia episodes of newly confirmed pneumonia according to the modified Centers for Disease Control and Prevention (CDC) criteria.
Measured: 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
Occurrence of acute kidney insufficiency defined with Kidney Disease Improving Global Outcomes (KDIGO) ≥ 2
Measured: 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
Occurrence of reintervention because of surgical complication
Measured: 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
Occurrence of a new onset of postoperative atrial fibrillation
Measured: 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
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).
Measured: from Hour 24 to Hour 48
Monitore the adverse effects of intravenous lidocaine
Number of adverse effects of intravenous experimental treatment
Measured: 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
Maximal total plasma lidocaine concentrations : Cmax , measured 5 minutes after the end of the IV lidocaine bolus
Measured: 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
Maximal free plasma lidocaine concentrations : Cmaxμ, measured 5 minutes after the end of the IV lidocaine bolus
Measured: 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
Steady-state total plasma lidocaine concentration : Css, measured at the end of IV continuous lidocaine administration
Measured: 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
Steady-state free plasma lidocaine concentration : Cssµ, measured at the end of IV continuous lidocaine administration
Measured: Day 0 (at the end of IV continuous lidocaine administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The ILHEP study is a multicenter, prospective, randomized, controlled double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590830
- Sponsor's protocol ID
- 35RC23_8878_ILHEP
- Other IDs
- 2025-522462-73-00, 2025
- Acronym
- ILHEP
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Intravenous Lidocaine on Postoperative Opioid Related-side Effects After Open HEPatectomy: a Multicentre Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07590830
- Acronym / sponsor ID
- ILHEP / 35RC23_8878_ILHEP
- Conditions
- Hepatectomy
- Keywords
- Lidocaine, Pain management, Analgesics, Postoperative opioid related-side effects, Double-Blind Method, Hepatectomy, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The ILHEP study is a multicenter, prospective, randomized, controlled double-blind study
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous LidocaineStandard anaesthesia protocol with lidocaine |
| Control Group | Placebo comparator | Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating PlaceboStandard anaesthesia protocol with placebo (NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- Exclusion criterion 2 : Allergy or contraindication to lidocaine or one of its excipients and, in particular:
- 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:
- Exclusion criterion 5 : Ketoprofen contraindication and, in particular:
- Exclusion criterion 7 : Transplant surgery or transplanted patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous LidocaineAlso: LidocaineStandard general anaesthesia induction protocol with pre-defined bolus of lidocaine and standard general anaesthesia maintenance protocol with pre-defined continuous intravenous infusion of lidocaine | Drug | Lidocaine Group |
| Standardized General Anesthesia Induction and Maintenance Protocol incorporating PlaceboAlso: PlaceboStandard general anaesthesia induction protocol with pre-defined bolus of placebo and standard general anaesthesia maintenance protocol with pre-defined continuous intravenous infusion of placebo | Drug | Control Group |
Primary outcome
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.
Time frame: 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)
22 secondary outcomes
Determine the occurrence of postoperative opioid-related nausea and vomiting
Time frame: from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related hypoxemia
Time frame: from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related ileus
Time frame: from Hour 0 to Hour 48
Determine the occurrence of postoperative opioid-related absence of flatus or stools
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: from Hour 0 to Hour 48
Determine if lidocaine can reduce postoperative opioid consumption
Time frame: from Hour 0 to Hour 48
Determine if lidocaine can reduce the delay to obtain an Aldrete score ≥ 9 after extubation
Time frame: 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)
Time frame: from Hour 0 to Day 28
Determine if lidocaine reduces the length of stay in the hospital
Time frame: from Hour 0 to Day 28
Determine if lidocaine reduces the incidence of the most frequent complications, particularly pneumonia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from Hour 24 to Hour 48
Monitore the adverse effects of intravenous lidocaine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0 (at the end of IV continuous lidocaine administration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine in people with Hepatectomy, run by Rennes University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pr Hélène BELOEIL, MD (+33299282422, helene.beloeil@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: from Hour 0 (extubation) to Hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.