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CompletedNCT02525016SPIRALUpdated Dec 19, 2025

Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

A Phase 3 interventional study of Blood sampling and Lidocaine in Obesity and Bariatric Surgery, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 68 Years
Sex
All
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Study 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.

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Conditions studied

  • Obesity
  • Bariatric Surgery

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Keywords

  • Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 68 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    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

    Biological: Blood sampling · Drug: Lidocaine

Interventions

  • BiologicalBlood sampling
  • DrugLidocaine
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What researchers measure

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.

    Time frame: From bolus to day 1 after cessation of administration

Secondary outcomes

  1. 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.

    Time frame: Up to 2 days after surgery

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Study locations

1 site
  • Hôpital Edouard Herriot - Département d'anesthésie réanimation
    Lyon, 69437, France
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References and documents

Publications

  • 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. PubMed 30399021 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02525016
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Aug 17, 2015
Start date
Sep 2015
Primary completion
May 2016
Completion
Jun 2016
Last update
Dec 19, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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