Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

Phase 3

Completed

• Conditions: Obesity; Bariatric Surgery
• Interventions: Biological: Blood sampling; Drug: Lidocaine

• Registration Number: NCT02525016
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Study Start: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
assessment of plasmatic lidocaine rate	Blood sampling	Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine
assessment of plasmatic lidocaine rate	Lidocaine	Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine

Primary Outcome Measures

Name	Time	Method
Plasmatic concentration of lidocaine	From bolus to day 1 after cessation of administration	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.

Secondary Outcome Measures

Name	Time	Method
occurence of adverse events related to lidocaine use	Up to 2 days after surgery	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.

Trial Locations

Locations (1)

Hôpital Edouard Herriot - Département d'anesthésie réanimation; 🇫🇷 LYON cedex 03, France