<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03290404</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC17.0072 fLACON</org_study_id>
    <nct_id>NCT03290404</nct_id>
  </id_info>
  <brief_title>Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization</brief_title>
  <acronym>fLACON</acronym>
  <official_title>Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Axillary block is the good anesthetic technique for upper limb surgery without exceeding a&#xD;
      certain total dose injected of Local Anesthetic (AL).&#xD;
&#xD;
      The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of&#xD;
      ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL&#xD;
      concentration, thus decreasing the risks.&#xD;
&#xD;
      No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper&#xD;
      limb surgery by axillary block.&#xD;
&#xD;
      The literature overestimating probably the rate of failure of the locoregional anesthesia&#xD;
      under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block&#xD;
      ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in&#xD;
      standard practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">March 19, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Resort to an anesthesia for help in case of ineffectiveness of the block</measure>
    <time_frame>Day 1</time_frame>
    <description>Yes or no Yes or No</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Block depth</measure>
    <time_frame>Day 1</time_frame>
    <description>Bromage score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time of Block</measure>
    <time_frame>Day 1</time_frame>
    <description>Minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>Total dose of Lidocaïne adrenaline used</measure>
    <time_frame>Day 1</time_frame>
    <description>mg</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>questionnaire score</description>
  </other_outcome>
  <enrollment type="Actual">292</enrollment>
  <condition>Axillary Block</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult operated for the upper limb under block axillaire&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients operated for the upper limb under block axillaire&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medical advice to realize axillary block&#xD;
&#xD;
          -  medical advice to local anaesthetic&#xD;
&#xD;
          -  Allergy&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  ASA 3 or more&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Instruction des Armées</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal de Cornouaille</name>
      <address>
        <city>Quimper</city>
        <zip>29017</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Axillary Block</keyword>
  <keyword>LidocaÏne 1% adrenaliné</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290404
org study id: 29BRC17.0072 fLACON
nct id: NCT03290404
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Resort to an anesthesia for help in case of ineffectiveness of the block
time frame: Day 1
description: Yes or no Yes or No
measure: Block depth
time frame: Day 1
description: Bromage score
measure: Time of Block
time frame: Day 1
description: Minutes
measure: Total dose of Lidocaïne adrenaline used
time frame: Day 1
description: mg
measure: Patient satisfaction
time frame: Day 1
description: questionnaire score
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor