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

Phase 3

Completed

• Conditions: Carcinologic Ear, Nose, and Throat (ENT) Surgery
• Interventions: Drug: Glucose 5% (placebo); Drug: Lidocaine 20mg/ml

• Registration Number: NCT02894710
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Study Start: 2016-12
• Primary Completion: 2019-06
• Status Verified: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose 5% (placebo)	Glucose 5% (placebo)	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.
Lidocaine 20mg/ml	Lidocaine 20mg/ml	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).

Primary Outcome Measures

Name	Time	Method
Total morphine requirement during the first 48 postoperative hours	48 postoperative hours (H48)	Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.

Secondary Outcome Measures

Name	Time	Method
Total morphine requirement	24 postoperative hours (H24)	Total morphine requirement during the first 24 postoperative hours.
Evaluation of chronic post-surgical pain	3 to 6 months after surgery (M3-6)	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)
Remifentanil peroperative consumption	At the end of surgery (an average of 3 hours et 10 minutes)	from the beginning of anesthesia to end of surgery
Incidence of side effects that can be attributed to lidocaine infusion	3 to 6 months after surgery (M3-6)

Trial Locations

Locations (2)

Centre Léon Bérard; 🇫🇷 Lyon, France

Hospices Civils de Lyon / Hôpital de la Croix Rousse; 🇫🇷 Lyon, France