CompletedPhase 3

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

France143 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total morphine requirement during the first 48 postoperative hours

Timeframe: 48 postoperative hours (H48)

Trial details

NCT IDNCT02894710

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Carcinologic Ear, Nose, and Throat (ENT) Surgery trials