Carcinologic Ear, Nose, and Throat (ENT) Surgery Clinical Trial
— ELICOOfficial title:
Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain
Verified date | December 2019 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | December 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon | |
France | Hospices Civils de Lyon / Hôpital de la Croix Rousse | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total morphine requirement during the first 48 postoperative hours | Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour. | 48 postoperative hours (H48) | |
Secondary | Remifentanil peroperative consumption | from the beginning of anesthesia to end of surgery | At the end of surgery (an average of 3 hours et 10 minutes) | |
Secondary | Total morphine requirement | Total morphine requirement during the first 24 postoperative hours. | 24 postoperative hours (H24) | |
Secondary | 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) | 3 to 6 months after surgery (M3-6) | |
Secondary | Incidence of side effects that can be attributed to lidocaine infusion | 3 to 6 months after surgery (M3-6) |