<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/NCT01673542</url>
  </required_header>
  <id_info>
    <org_study_id>EMLAX 2012-001976-13</org_study_id>
    <nct_id>NCT01673542</nct_id>
  </id_info>
  <brief_title>Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of&#xD;
      dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the&#xD;
      puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required&#xD;
      for a 50% difference with the standard deviation of the control group, a significance level&#xD;
      of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35&#xD;
      patients per group.&#xD;
&#xD;
      The expected benefit is the reduction of pain at the skin puncture during the realization of&#xD;
      BAX.&#xD;
&#xD;
      Improving professional practice and quality care&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®</measure>
    <description>The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation pain</measure>
    <description>- Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction</measure>
    <description>- Assessment of satisfaction of anesthetists</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>success</measure>
    <description>The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Surgery Scheduled</condition>
  <arm_group>
    <arm_group_label>Lidocaine-Prilocaine 5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexeryl</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine-Prilocaine 5%</intervention_name>
    <arm_group_label>Lidocaine-Prilocaine 5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DEXERYL</intervention_name>
    <arm_group_label>Dexeryl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Hospitalized for upper extremity surgery scheduled&#xD;
&#xD;
          -  Having an axillary block anesthesia.&#xD;
&#xD;
          -  Free subject, without subordination or guardianship&#xD;
&#xD;
          -  Patients undergoing a social security system or benefiting through a third party&#xD;
&#xD;
          -  Informed consent and signed by the patient after clear and honest information on the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and&#xD;
             its derivatives&#xD;
&#xD;
          -  Hypersensitivity to local anesthetics of the amide&#xD;
&#xD;
          -  Congenital Methemoglobinemia&#xD;
&#xD;
          -  Porphyrias&#xD;
&#xD;
          -  Glucose-6-phosphate dehydrogenase&#xD;
&#xD;
          -  Hypersensitivity to any component of Dexeryl ®&#xD;
&#xD;
          -  Disorders of atrioventricular conduction requiring permanent pacing not yet realized.&#xD;
&#xD;
          -  Epilepsy uncontrolled by treatment&#xD;
&#xD;
          -  Patients on anticoagulants&#xD;
&#xD;
          -  Skin infection from the puncture site&#xD;
&#xD;
          -  Patients with psychiatric disorders or dementia&#xD;
&#xD;
          -  Cons-indication for infusion Isofundine ®:&#xD;
&#xD;
          -  Severe congestive heart failure&#xD;
&#xD;
          -  anuria&#xD;
&#xD;
          -  oligoanuria&#xD;
&#xD;
          -  Fluid retention&#xD;
&#xD;
          -  hyperkalemia&#xD;
&#xD;
          -  hypercalcemia&#xD;
&#xD;
          -  Metabolic alkalosis&#xD;
&#xD;
          -  Patients not receiving a social security system or not qualifying through a third&#xD;
             party&#xD;
&#xD;
          -  People receiving more protection ie minors, persons deprived of liberty by a judicial&#xD;
             or administrative decision, guests staying in a hospital or office, adults under legal&#xD;
             protection,&#xD;
&#xD;
          -  Pregnant or nursing women, women of childbearing age who do not have effective&#xD;
             contraception (hormonal / mechanical: oral, injectable, transdermal, implantable,&#xD;
             intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Service Anesthésie-Réanimation</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>October 10, 2016</last_update_submitted>
  <last_update_submitted_qc>October 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
    <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01673542
org study id: EMLAX 2012-001976-13
nct id: NCT01673542
lead sponsor: 
has dmc: Yes
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of
      dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the
      puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required
      for a 50% difference with the standard deviation of the control group, a significance level
      of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35
      patients per group.

      The expected benefit is the reduction of pain at the skin puncture during the realization of
      BAX.

      Improving professional practice and quality care
measure: Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
description: The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery
measure: evaluation pain
description: - Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,
measure: satisfaction
description: - Assessment of satisfaction of anesthetists
measure: success
description: The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic
arm group label: Lidocaine-Prilocaine 5%
arm group type: Experimental
arm group label: Dexeryl
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Lidocaine-Prilocaine 5%
arm group label: Lidocaine-Prilocaine 5%
intervention type: Drug
intervention name: DEXERYL
arm group label: Dexeryl
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: Lidocaine
mesh term: Prilocaine
mesh term: Lidocaine, Prilocaine Drug Combination