Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

NCT ID: NCT02525016

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

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.

Detailed Description

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Conditions

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Obesity Bariatric Surgery

Keywords

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Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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assessment of plasmatic lidocaine rate

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

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

Lidocaine

Intervention Type DRUG

Interventions

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Blood sampling

Intervention Type BIOLOGICAL

Lidocaine

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Edouard Herriot - Département d'anesthésie réanimation

Lyon, , France

Site Status

Countries

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France

References

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Carabalona JF, Delwarde B, Duclos A, Le Goff MC, Moulsma M, Citterio-Quentin A, Bouffard Y, Rimmele T. Serum Concentrations of Lidocaine During Bariatric Surgery. Anesth Analg. 2020 Jan;130(1):e5-e8. doi: 10.1213/ANE.0000000000003905.

Reference Type RESULT
PMID: 30399021 (View on PubMed)

Other Identifiers

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69HCL15_0057

Identifier Type: -

Identifier Source: org_study_id