Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery (SPIRAL)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Bariatric Surgery; Obesity

Treatments: Drug: Lidocaine; Biological: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02525016

69HCL15_0057

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

assessment of plasmatic lidocaine rate

Experimental group

Description:

Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine

Treatment:

Biological: Blood sampling

Drug: Lidocaine