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

NCT02894710 | Completed Phase 3

• 2 other identifiers: 69HCL15_07432015-005799-90
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

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.

Conditions

Carcinologic Ear, Nose, and Throat (ENT) Surgery

Keywords

postoperative pain; intravenous lidocaine; chronic post-surgical pain; remifentanil; patient controlled analgesia; morphine consumption; ENT surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Remifentanil peroperative consumption

  At the end of surgery (an average of 3 hours et 10 minutes)

• Total morphine requirement

  24 postoperative hours (H24)

• Evaluation of chronic post-surgical pain

  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)

Study Arms (2)

Lidocaine 20mg/ml

EXPERIMENTAL

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

Glucose 5% (placebo)

PLACEBO COMPARATOR

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)

Interventions

Lidocaine 20mg/ml DRUG

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).

Lidocaine 20mg/ml

Glucose 5% (placebo) DRUG

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.

Glucose 5% (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hospices Civils de Lyon / Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Related Publications (2)

• Omar E, Wallon G, Bauer C, Axiotis G, Bouix C, Soubirou JL, Aubrun F. Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial. Trials. 2019 Apr 15;20(1):220. doi: 10.1186/s13063-019-3303-x.

  PMID: 30987664 BACKGROUND

• Wallon G, Erbacher J, Omar E, Bauer C, Axiotis G, Thevenon S, Soubirou JL, Aubrun F. Effect of intravenous lidocaine on pain after head and neck cancer surgery (ELICO trial): A randomised controlled trial. Eur J Anaesthesiol. 2022 Sep 1;39(9):735-742. doi: 10.1097/EJA.0000000000001712. Epub 2022 Jul 20.

  PMID: 35852564 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Glucose

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 9, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (2)