Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

Conditions
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Obesity, Bariatric Surgery

Intervention / Treatment
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* Biological: Blood sampling
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: assessment of plasmatic lidocaine rate<br>Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine | Biological: Blood sampling<br> <br> Drug: Lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From bolus to day 1 after cessation of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 2 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety