Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

Hospices Civils de Lyon50 enrolled

Overview

Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery. Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use. Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe. Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient. Investigators get approbation of local ethic committee for this work.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity Bariatric Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 68 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy * Body mass index \> = 40 kg/m2 * Informed consent signed * Patient treated with intravenous administration of lidocaine Exclusion Criteria: * Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria) * Concomitant use of beta blocker and others anti arrhythmic drugs * Cardiac or hepatic insufficiency * Pregnancy

Outcomes

Primary Outcomes

Plasmatic concentration of lidocaine

Blood samples will be removed by the peripheral catheter or direct venous puncture with other blood sample usually performed during post-operative period. First sample will be taken after initial bolus (ie 10 min after initiation of perfusion), second at 20 min, third at 30 min. The fourth and fifth samples will be taken after change of posology (from 2 to 1 mg/kg/h at the end of surgery) and at the end of administration. The sixth sample will be performed the day after the end of administration.

Time frame: From bolus to day 1 after cessation of administration

Secondary Outcomes

occurence of adverse events related to lidocaine use

neurologic (seizure, dysgeusia, dizziness) or cardiologic events (atrio ventricular block, ventricular rhythm disorder) will be assessed after surgery, during hospitalization in post-operative room or intensive care unit.

Time frame: Up to 2 days after surgery