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NCT Number: NCT02894710

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

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.

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Key information

Conditions

Carcinologic Ear, Nose, and Throat (ENT) Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Léon Bérard, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Total morphine requirement during the first 48 postoperative hours

    Time frame: 48 postoperative hours (H48)

    Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.

Secondary outcomes

  1. Remifentanil peroperative consumption

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

    from the beginning of anesthesia to end of surgery

  2. Total morphine requirement

    Time frame: 24 postoperative hours (H24)

    Total morphine requirement during the first 24 postoperative hours.

  3. Evaluation of chronic post-surgical pain

    Time frame: 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)

  4. Incidence of side effects that can be attributed to lidocaine infusion

    Time frame: 3 to 6 months after surgery (M3-6)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ELICO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2016
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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