Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

NCT02525016 | Completed Phase 3

• 1 other identifier: 69HCL15_0057
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Bariatric Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• occurence of adverse events related to lidocaine use

  Up to 2 days after surgery

Study Arms (1)

assessment of plasmatic lidocaine rate

EXPERIMENTAL

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; Drug: Lidocaine

Interventions

Blood sampling BIOLOGICAL

assessment of plasmatic lidocaine rate

Lidocaine DRUG

assessment of plasmatic lidocaine rate

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria)
• Concomitant use of beta blocker and others anti arrhythmic drugs
• Cardiac or hepatic insufficiency
• Pregnancy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot - Département d'anesthésie réanimation

Lyon, 69437, France

Location

Related Publications (1)

• 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.

  PMID: 30399021 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection; Lidocaine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)