Carcinologic Ear, Nose, and Throat (ENT) Surgery
Conditions
Keywords
postoperative pain, intravenous lidocaine, chronic post-surgical pain, remifentanil, patient controlled analgesia, morphine consumption, ENT surgery
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.
Interventions
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).
DRUGGlucose 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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine requirement during the first 48 postoperative hours | 48 postoperative hours (H48) | Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil peroperative consumption | At the end of surgery (an average of 3 hours et 10 minutes) | from the beginning of anesthesia to end of surgery |
| Total morphine requirement | 24 postoperative hours (H24) | Total morphine requirement during the first 24 postoperative hours. |
| Evaluation of chronic post-surgical pain | 3 to 6 months after surgery (M3-6) | 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) |
| Incidence of side effects that can be attributed to lidocaine infusion | 3 to 6 months after surgery (M3-6) | — |
Countries
France
Outcome results
None listed