Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization (fLACON)

April 5, 2018 updated by: University Hospital, Brest

Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL).

The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks.

No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block.

The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

292

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
      • Brest, France, 29609
        • CHRU de Brest
      • Brest, France, 29200
        • Hôpital Instruction des Armées
      • Quimper, France, 29017
        • Centre Hospitalier Intercommunal de Cornouaille

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult operated for the upper limb under block axillaire

Description

Inclusion Criteria:

  • Patients operated for the upper limb under block axillaire
  • Adult
  • non-opposition

Exclusion Criteria:

  • medical advice to realize axillary block
  • medical advice to local anaesthetic
  • Allergy
  • Pregnant
  • ASA 3 or more

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resort to an anesthesia for help in case of ineffectiveness of the block
Time Frame: Day 1
Yes or no Yes or No
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block depth
Time Frame: Day 1
Bromage score
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Block
Time Frame: Day 1
Minutes
Day 1
Total dose of Lidocaïne adrenaline used
Time Frame: Day 1
mg
Day 1
Patient satisfaction
Time Frame: Day 1
questionnaire score
Day 1

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

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)

November 13, 2017

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29BRC17.0072 fLACON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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