Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO) (ELICO)
Carcinologic Ear, Nose, and Throat (ENT) Surgery
About this trial
This is an interventional treatment trial for Carcinologic Ear, Nose, and Throat (ENT) Surgery focused on measuring postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing major carcinological ENT surgery (total laryngectomy, oropharyngectomy with or without mandibulotomy, crico-hyoido-epiglotto-pexy, intraoral extended resection, partial laryngectomy, partial pharyngectomy, extended pelvectomy, pelviglossectomy, with or without pectoralis major flap or free flap, with or without lymphadenectomy)
- Patient receiving standardized Patient Controlled Analgesia (PCA)
- Written informed consent
Exclusion Criteria:
- Hypersensitivity to local anesthetics of the amide group,
- Acute porphyria
- Atrioventricular conduction disorders requiring permanent electro-systolic
- Epilepsy not controlled by treatment
- Hepatocellular insufficiency (PT<50%) or cirrhosis
- Systolic heart failure (LVEF <50%)
- Major inflation State
- Hypersensitivity to any component of Glucose 5%
- Treatment with beta-blockers or antiarrhythmic of Vaughan Williams classification
- BMI > 30kg/m2
- Patient already treated for chronic pain with level 3 analgesic or for neuropathic pain
- Pregnant or lactating women
- Refusal to give consent
- Patient under legal protection measure
Sites / Locations
- Hospices Civils de Lyon / Hôpital de la Croix Rousse
- Centre Léon Bérard
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lidocaine 20mg/ml
Glucose 5% (placebo)
Patients in Lidocaine group received an intravenous bolus injection of 1,5 mg/kg lidocaine (0,075mL/kg of Lidocaine 20mg/mL) followed by a continuous lidocaine infusion of 2 mg/kg/hr during surgery (0,1mL/kg/hr of Lidocaine 20mg/mL) and 1 mg/kg/hr in recovery room (0,05mL/kg/hr of Lidocaine 20mg/mL).
Patients in control group received an intravenous bolus injection of 0,075mL/kg of placebo (Glucose 5%) by a continuous lidocaine infusion of 0,1mL/kg/hr of placebo (Glucose 5%) during surgery and 0,05mL/kg/hr of placebo (Glucose 5%) in recovery room.