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

September 30, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Lyon, France, 69004
        • Hospices Civils de Lyon / Hôpital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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).
Placebo Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 postoperative hours (H48)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of surgery (an average of 3 hours et 10 minutes)
Total morphine requirement
Time Frame: 24 postoperative hours (H24)
Total morphine requirement during the first 24 postoperative hours.
24 postoperative hours (H24)
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)
3 to 6 months after surgery (M3-6)
Incidence of side effects that can be attributed to lidocaine infusion
Time Frame: 3 to 6 months after surgery (M3-6)
3 to 6 months after surgery (M3-6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimated)

September 9, 2016

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0743
  • 2015-005799-90 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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