Carcinologic Ear, Nose, and Throat (ENT) SurgeryPhase 3ELICONCT02894710
Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)
A Phase 3 study testing Lidocaine 20mg/ml in people with Carcinologic Ear, Nose, and Throat (ENT) Surgery, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinologic Ear, Nose, and Throat (ENT) Surgery
- What is being tested?
- Lidocaine 20mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2016to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon / Hôpital de la Croix Rousse
Lyon, 69004
Centre Léon Bérard
Lyon, 69008
About this study
Official title: 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.
- Being tested
- Lidocaine 20mg/ml, Glucose 5% (placebo)
- Keywords
- postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 20mg/mlDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Glucose 5% (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine requirement during the first 48 postoperative hours
Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.
Measured: 48 postoperative hours (H48)
Secondary outcomes (4)
Remifentanil peroperative consumption
from the beginning of anesthesia to end of surgery
Measured: At the end of surgery (an average of 3 hours et 10 minutes)
Total morphine requirement
Total morphine requirement during the first 24 postoperative hours.
Measured: 24 postoperative hours (H24)
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)
Measured: 3 to 6 months after surgery (M3-6)
Incidence of side effects that can be attributed to lidocaine infusion
Measured: 3 to 6 months after surgery (M3-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinologic Ear, Nose, and Throat (ENT) SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894710
- Sponsor's protocol ID
- 69HCL15_0743
- Other IDs
- 2015-005799-90, 2015
- Acronym
- ELICO
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2016
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30987664Wallon 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.
PubMed 35852564
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain
- ClinicalTrials.gov ID
- NCT02894710
- Acronym / sponsor ID
- ELICO / 69HCL15_0743
- Keywords
- postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 20mg/ml | Experimental | Drug: Lidocaine 20mg/mlPatients 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) | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 20mg/mlPatients 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)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) |
Primary outcome
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.
4 secondary outcomes
Remifentanil peroperative consumption
Time frame: At the end of surgery (an average of 3 hours et 10 minutes)
Total morphine requirement
Time frame: 24 postoperative hours (H24)
Evaluation of chronic post-surgical pain
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 30987664Omar 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 publication: PubMed 35852564Wallon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 20mg/ml in people with Carcinologic Ear, Nose, and Throat (ENT) Surgery, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine requirement during the first 48 postoperative hours (time frame: 48 postoperative hours (H48)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894710, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.