Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Carcinologic Ear, Nose, and Throat (ENT) Surgery

Treatments: Drug: Glucose 5% (placebo); Drug: Lidocaine 20mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT02894710

2015-005799-90 (EudraCT Number)

69HCL15_0743

Details and patient eligibility

About

Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption.

This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours.

Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 2 patient groups, including a placebo group

Lidocaine 20mg/ml

Experimental group

Description:

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).

Treatment:

Drug: Lidocaine 20mg/ml

Glucose 5% (placebo)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Glucose 5% (placebo)