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

August 2, 2017 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • LYON cedex 03, France, 69437
        • Hôpital Edouard Herriot - Département d'anesthésie réanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Lidocaine
Biological: Blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From bolus to day 1 after cessation of administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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