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

Study Overview
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Brief Summary
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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.

Official Title
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Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain

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

Intervention / Treatment
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* Drug: Lidocaine 20mg/ml
* Drug: Glucose 5% (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine 20mg/ml<br>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). | Drug: Lidocaine 20mg/ml<br>* 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).<br>|
| Placebo Comparator: Glucose 5% (placebo)<br>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. | Drug: Glucose 5% (placebo)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine requirement during the first 48 postoperative hours | Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour. | 48 postoperative hours (H48) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remifentanil peroperative consumption | from the beginning of anesthesia to end of surgery | At the end of surgery (an average of 3 hours et 10 minutes) | 
| Total morphine requirement | Total morphine requirement during the first 24 postoperative hours. | 24 postoperative hours (H24) | 
| Evaluation of chronic post-surgical pain | Chronic post-surgical pain will be evaluated from 3 to 6 month after surgery by a personal interview of each patient with the french version of McGill pain questionnaire (Questionnaire de Saint-Antoine - version abrégée) | 3 to 6 months after surgery (M3-6) | 
| Incidence of side effects that can be attributed to lidocaine infusion |  | 3 to 6 months after surgery (M3-6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery