2025-522462-73-00RecruitingPhase 4
ILHEP : Effect of perioperative Intravenous Lidocaine on postoperative opioid related-side effects after open HEPatectomy: a multicentre prospective randomized controlled study
Centre Hospitalier Universitaire De Rennes9 sites in 1 country312 target enrollmentStarted: January 1, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 312
- Locations
- 9
- Primary Endpoint
- Composite endpoint defined as the occurrence of a postoperative opioid-related adverse event within the first 48 hours after extubation, like : postoperative nausea and vomiting, postoperative hypoxemia (SpO₂ < 95% requiring oxygen supplementation), or postoperative ileus (intolerance to an oral diet, e.g., soft food or light meal), assessed blinded to the randomization group.
Study Overview
Brief Summary
To compare the effects of a perioperative lidocaine infusion with that of placebo on postoperative opioid related side effects after open hepatectomy.
Study Design
- Allocation
- Randomized
- Primary Purpose
- [d-1 Or D0] To D28
- Masking
- Double (Carer, Monitor, Subject, Investigator)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Undergoing a scheduled surgery for open hepatectomy
- •Effective contraception in accordance with CFTG recommendations
- •Having received oral and written information about the protocol and having signed a consent form to take part in this research
- •Affiliated to a social security scheme
Exclusion Criteria
- •Weight > 100 kg
- •Obstructive sleep apnoea syndrome
- •Severe hepatic insufficiency (Prothrombin Ratio < 15%)
- •Patient with an ongoing opioid medication that will blur the results
- •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 hospitalised for a different reason
- •Known participation in other interventional research (RIPH1 or RIPH2)
- •Allergy or contra-indication to lidocaine or one of its excipients and, in particular: 1) Treatment with following antiarythmic medication : class I, class III or Sotalol | 2) Heart failure NYHA grade 3-4, AV-block >1, without pacemaker | 3) Acute porphyria | 4) Uncontrolled epilepsy / Seizure at enrollment
- •Allergy to one of the drugs used for anaesthesia or one of their excipients
- •Nefopam contraindication and, in particular: 1) Renal insufficiency (Creatinine clearance < 50 mL/min) | 2) Inflammatory bowel disease | 3) Allergy
- •Ketoprofen contraindication and, in particular: 1) Untreated glaucoma | 2) Uncontrolled epilepsy | 3) Allergy
- •Urgent surgery
- •Transplant surgery or transplanted patients
- •Surgery with planned regional anaesthesia
- •Patient with a preoperative Sp02 < 95%
Arms & Interventions
SODIUM CHLORIDE
Placebo
Intervention: SODIUM CHLORIDE (Drug)
LIDOCAINE HYDROCHLORIDE
Test
Intervention: LIDOCAINE HYDROCHLORIDE (Drug)
Outcomes
Primary Outcomes
Composite endpoint defined as the occurrence of a postoperative opioid-related adverse event within the first 48 hours after extubation, like : postoperative nausea and vomiting, postoperative hypoxemia (SpO₂ < 95% requiring oxygen supplementation), or postoperative ileus (intolerance to an oral diet, e.g., soft food or light meal), assessed blinded to the randomization group.
Composite endpoint defined as the occurrence of a postoperative opioid-related adverse event within the first 48 hours after extubation, like : postoperative nausea and vomiting, postoperative hypoxemia (SpO₂ < 95% requiring oxygen supplementation), or postoperative ileus (intolerance to an oral diet, e.g., soft food or light meal), assessed blinded to the randomization group.
Secondary Outcomes
- Occurrence of a postoperative opioid-related nausea and vomiting within the first 48 hours after extubation ; the need for anti-emetic medication will also be recorded
- Occurrence of a postoperative opioid-related hypoxemia within the first 48 hours after extubation ; the duration of oxygen treatment will also be recorded
- Occurrence of a postoperative opioid-related ileus within the first 48 hours after extubation
- Occurrence of a postoperative opioid-related absence of flatus or stools
- Postoperative pain (numeric rating scale) after extubation at rest and during movement: every 10 minutes in PACU (Post-Anesthesia Care Unit) and every 6 hours until 48 hours after surgery
- Opioid consumption (mg) during the 48 hours following extubation
- Time between extubation (H0) and an Aldrete score ≥ 9
- Rate of unscheduled admission in intensive care unit
- Hospital length of stay (max 28 days) defined as the number of days after extubation (H0) before first hospital discharge
- Pneumonia episodes of newly confirmed pneumonia according to the modified CDC criteria within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
- Acute kidney insufficiency defined with KDIGO ≥ 2 within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
- Need for reintervention because of surgical complication within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
- New onset of postoperative atrial fibrillation within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
- Quality of recovery measured with the QoR40 score between 24 and 48 hours after extubation
- Adverse effects of IV experimental treatment
- Ancillary pharmacological study in 20 patients included in the coordinating centre: plasma lidocaine concentration
Investigators
BELOEIL Hélène
Scientific
Centre Hospitalier Universitaire De Rennes
Study Sites (9)
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