Clinical trial NCT02894710: Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinologic Ear, Nose, and Throat (ENT) Surgery
Keywords: postoperative pain
intravenous lidocaine
chronic post-surgical pain
remifentanil
patient controlled analgesia
morphine consumption
ENT surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total morphine requirement during the first 48 postoperative hours
timeFrame: 48 postoperative hours (H48)
Secondary outcomes:
measure: Remifentanil peroperative consumption
timeFrame: At the end of surgery (an average of 3 hours et 10 minutes)
measure: Total morphine requirement
timeFrame: 24 postoperative hours (H24)
measure: Evaluation of chronic post-surgical pain
timeFrame: 3 to 6 months after surgery (M3-6)
measure: Incidence of side effects that can be attributed to lidocaine infusion
timeFrame: 3 to 6 months after surgery (M3-6)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon / Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
References:
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.
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.