Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)
CompletedPhase 3NCT02894710
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain
- Conditions
- Carcinologic Ear, Nose, and Throat (ENT) Surgery
- Interventions
- Drug: Lidocaine 20mg/ml
- Drug: Glucose 5% (placebo)
- Sponsor
- Hospices Civils de Lyon
- Start date
- 2016-12
- Primary completion
- 2019-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02894710