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OpenTrials
Completed

NCT Number: NCT02525016

Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

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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Key information

Conditions

Obesity Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Edouard Herriot - Département d'anesthésie réanimation

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

Lidocaine

Drug

Primary outcomes

  1. Plasmatic concentration of lidocaine

    Time frame: 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 outcomes

  1. occurence of adverse events related to lidocaine use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SPIRAL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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