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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894710
Other study ID # 69HCL15_0743
Secondary ID 2015-005799-90
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2016
Est. completion date December 2019

Study information

Verified date December 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Carcinologic Ear, Nose, and Throat (ENT) Surgery

Intervention

Drug:
Lidocaine 20mg/ml
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).
Glucose 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.

Locations

Country Name City State
France Centre Léon Bérard Lyon
France Hospices Civils de Lyon / Hôpital de la Croix Rousse Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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)