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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
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).
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.
Hospices Civils de Lyon / Hôpital de la Croix Rousse
Lyon, France
Centre Léon Bérard
Lyon, France
Total morphine requirement during the first 48 postoperative hours
Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.
Time frame: 48 postoperative hours (H48)
Remifentanil peroperative consumption
from the beginning of anesthesia to end of surgery
Time frame: At the end of surgery (an average of 3 hours et 10 minutes)
Total morphine requirement
Total morphine requirement during the first 24 postoperative hours.
Time frame: 24 postoperative hours (H24)
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)
Time frame: 3 to 6 months after surgery (M3-6)
Incidence of side effects that can be attributed to lidocaine infusion
Time frame: 3 to 6 months after surgery (M3-6)
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