LIDOCAINE HYDROCHLORIDE for Postanesthetic complications following open hepatectomy

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Undergoing a scheduled surgery for open hepatectomy\n- Effective contraception in accordance with CFTG recommendations\n- Having received oral and written information about the protocol and having signed a consent form to take part in this research\n- Affiliated to a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Weight > 100 kg\n- Obstructive sleep apnoea syndrome\n- Severe hepatic insufficiency (Prothrombin Ratio < 15%)\n- Patient with an ongoing opioid medication that will blur the results\n- 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\n- Known participation in other interventional research (RIPH1 or RIPH2)\n- 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\n- Allergy to one of the drugs used for anaesthesia or one of their excipients\n- Nefopam contraindication and, in particular: 1) Renal insufficiency (Creatinine clearance < 50 mL/min) | 2) Inflammatory bowel disease | 3) Allergy\n- Ketoprofen contraindication and, in particular: 1) Untreated glaucoma | 2) Uncontrolled epilepsy | 3) Allergy\n- Urgent surgery\n- Transplant surgery or transplanted patients\n- Surgery with planned regional anaesthesia\n- Patient with a preoperative Sp02 < 95%"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Occurrence of any of the listed opioid-related adverse events within 48 hours after extubation; hypoxemia defined as SpO₂ < 95% requiring oxygen supplementation; ileus defined as intolerance to an oral diet (e.g., soft food or light meal). Assessment is performed blinded to randomization."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Record occurrence of nausea and vomiting within 48 hours after extubation; record any use of anti-emetic medication."}
• {"endpoint_text":"- Occurrence of a postoperative opioid-related hypoxemia within the first 48 hours after extubation ; the duration of oxygen treatment will also be recorded","definition_or_measurement_approach":"Record episodes of hypoxemia within 48 hours after extubation (SpO₂ criteria per primary endpoint) and record duration of oxygen therapy."}
• {"endpoint_text":"- Occurrence of a postoperative opioid-related ileus within the first 48 hours after extubation","definition_or_measurement_approach":"Record clinical occurrence of postoperative ileus within 48 hours after extubation (intolerance to oral diet as defined)."}
• {"endpoint_text":"- Occurrence of a postoperative opioid-related absence of flatus or stools","definition_or_measurement_approach":"Record absence of flatus or stools postoperatively as an opioid-related outcome within the assessment window."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Numeric rating scale assessments at specified intervals: every 10 minutes in PACU and every 6 hours up to 48 hours after surgery, at rest and during movement."}
• {"endpoint_text":"- Opioid consumption (mg) during the 48 hours following extubation","definition_or_measurement_approach":"Total opioid consumption in milligrams during the 48 hours after extubation will be recorded."}
• {"endpoint_text":"- Time between extubation (H0) and an Aldrete score ≥ 9","definition_or_measurement_approach":"Measure elapsed time from extubation (H0) until Aldrete score reaches ≥9."}
• {"endpoint_text":"- Rate of unscheduled admission in intensive care unit","definition_or_measurement_approach":"Record occurrence (yes/no) of unplanned ICU admissions postoperatively."}
• {"endpoint_text":"- Hospital length of stay (max 28 days) defined as the number of days after extubation (H0) before first hospital discharge","definition_or_measurement_approach":"Count number of days from extubation to first discharge, up to 28 days maximum."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Record new pneumonia episodes meeting modified CDC criteria within 7 days post-surgery or until discharge (max 28 days)."}
• {"endpoint_text":"- Acute kidney insufficiency defined with KDIGO ≥ 2 within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)","definition_or_measurement_approach":"Identify acute kidney injury stage ≥2 per KDIGO criteria within 7 days post-surgery or until discharge (max 28 days)."}
• {"endpoint_text":"- Need for reintervention because of surgical complication within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)","definition_or_measurement_approach":"Record any reintervention for surgical complications within 7 days post-surgery or until discharge (max 28 days)."}
• {"endpoint_text":"- New onset of postoperative atrial fibrillation within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)","definition_or_measurement_approach":"Record new postoperative atrial fibrillation within 7 days or until discharge (max 28 days)."}
• {"endpoint_text":"- Quality of recovery measured with the QoR40 score between 24 and 48 hours after extubation","definition_or_measurement_approach":"Assess QoR-40 questionnaire between 24 and 48 hours after extubation to measure quality of recovery."}
• {"endpoint_text":"- Adverse effects of IV experimental treatment","definition_or_measurement_approach":"Monitor and record adverse events related to IV lidocaine administration per safety reporting procedures."}
• {"endpoint_text":"- Ancillary pharmacological study in 20 patients included in the coordinating centre: plasma lidocaine concentration","definition_or_measurement_approach":"Measure plasma lidocaine concentrations in 20 patients at the coordinating centre as part of an ancillary PK study."}

Methods

• Preoperative clinic screening at participating hospital sites: patients scheduled for open hepatectomy under general anaesthesia are identified during preoperative consultation or at hospital admission and assessed for eligibility; inclusion occurs after explanation of the protocol and signing of informed consent either the day before or on the day of surgery (France).

France

Earliest CTIS Part Ii Submission Date

17-12-2025

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

83

Number Of Sites

9

Number Of Participants

312

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Rennes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France