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

Primary Purpose

Carcinologic Ear, Nose, and Throat (ENT) Surgery

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lidocaine 20mg/ml
Glucose 5% (placebo)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinologic Ear, Nose, and Throat (ENT) Surgery focused on measuring postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon / Hôpital de la Croix Rousse
  • Centre Léon Bérard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine 20mg/ml

Glucose 5% (placebo)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Remifentanil peroperative consumption
from the beginning of anesthesia to end of surgery
Total morphine requirement
Total morphine requirement during the first 24 postoperative hours.
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)
Incidence of side effects that can be attributed to lidocaine infusion

Full Information

First Posted
August 11, 2016
Last Updated
December 17, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02894710
Brief Title
Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)
Acronym
ELICO
Official Title
Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinologic Ear, Nose, and Throat (ENT) Surgery
Keywords
postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine 20mg/ml
Arm Type
Experimental
Arm Description
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).
Arm Title
Glucose 5% (placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 20mg/ml
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Glucose 5% (placebo)
Intervention Description
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 Outcome Measure Information:
Title
Total morphine requirement during the first 48 postoperative hours
Description
Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.
Time Frame
48 postoperative hours (H48)
Secondary Outcome Measure Information:
Title
Remifentanil peroperative consumption
Description
from the beginning of anesthesia to end of surgery
Time Frame
At the end of surgery (an average of 3 hours et 10 minutes)
Title
Total morphine requirement
Description
Total morphine requirement during the first 24 postoperative hours.
Time Frame
24 postoperative hours (H24)
Title
Evaluation of chronic post-surgical pain
Description
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)
Time Frame
3 to 6 months after surgery (M3-6)
Title
Incidence of side effects that can be attributed to lidocaine infusion
Time Frame
3 to 6 months after surgery (M3-6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon / Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35852564
Citation
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.
Results Reference
derived
PubMed Identifier
30987664
Citation
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.
Results Reference
derived

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

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