<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/NCT03767868</url>
  </required_header>
  <id_info>
    <org_study_id>AntalyaTRH27</org_study_id>
    <nct_id>NCT03767868</nct_id>
  </id_info>
  <brief_title>An Indicator of Successful Peripheral Nerve Block</brief_title>
  <official_title>A Different Indicator of Successful Peripheral Nerve Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</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>
      The aim of the study was to investigate whether a color changing nail polish would be an&#xD;
      indicator to assess infraclavicular brachial plexus block success based on skin temperature&#xD;
      differences before and after performed the block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After performed the block, sensory and motor block assessments will be carried out by blinded&#xD;
      observer every 5 min after needle removal for 30 min in the regions of the radial, median,&#xD;
      ulnar, and musculocutaneous nerves of the forearm. Skin temperature measurements will be&#xD;
      performed from both the anesthetized side and the contralateral arm before the procedure and&#xD;
      every 5 min for 30 min by a blinded observer. Before the block, the color changing nail&#xD;
      polish will be applied to all hand nails of the patient. An independent observer will&#xD;
      photograph the reaction of the nail polish (i.e. color change) in both hands immediately&#xD;
      after application of nail polish and at two minute intervals for 30 min after performing the&#xD;
      block. Two blinded observers were reviewed the digital photographs. They were asked to&#xD;
      compare the colors of nail polish in both hands and to score the difference based on a&#xD;
      three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">March 11, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in the color of nail polish</measure>
    <time_frame>30 minutes</time_frame>
    <description>The photographs showing if there is the reaction of color of nail polish will be assessed after study completion by independent observers. They will be asked to compare the colors of nail polish before and after block performance in both hands and to rate the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference).</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Temperature Change, Body</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>color change in nail polish</intervention_name>
    <description>The determination of color change in nail polish will be based on differences in skin temperature before and after the block.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults between 18 and 65 years of age with infraclavicular brachial lexus block for&#xD;
        elective elbow, forearm, wrist, or hand surgery , were selected in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who received infraclavicular brachial plexus block for elective elbow,&#xD;
             forearm, wrist, or hand surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists class I, II or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients &lt;18 years old&#xD;
&#xD;
          -  &gt;65 years old&#xD;
&#xD;
          -  body mass index (BMI) &lt;20 or &gt;35 kg/m2&#xD;
&#xD;
          -  inability to provide written informed consent&#xD;
&#xD;
          -  refusal of regional anesthesia&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  contraindication for regional anesthesia&#xD;
&#xD;
          -  peripheral neurological disease,&#xD;
&#xD;
          -  Raynaud disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Sait Kavakli, MD</last_name>
    <role>Study Director</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulku Arslan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karabuk University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ferhat Enginar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antalya Training and Research Hospital</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Temperature Changes</mesh_term>
  </condition_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/NCT03767868
org study id: AntalyaTRH27
nct id: NCT03767868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to investigate whether a color changing nail polish would be an
      indicator to assess infraclavicular brachial plexus block success based on skin temperature
      differences before and after performed the block.
After performed the block, sensory and motor block assessments will be carried out by blinded
      observer every 5 min after needle removal for 30 min in the regions of the radial, median,
      ulnar, and musculocutaneous nerves of the forearm. Skin temperature measurements will be
      performed from both the anesthetized side and the contralateral arm before the procedure and
      every 5 min for 30 min by a blinded observer. Before the block, the color changing nail
      polish will be applied to all hand nails of the patient. An independent observer will
      photograph the reaction of the nail polish (i.e. color change) in both hands immediately
      after application of nail polish and at two minute intervals for 30 min after performing the
      block. Two blinded observers were reviewed the digital photographs. They were asked to
      compare the colors of nail polish in both hands and to score the difference based on a
      three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference)
observational model: Case-Only
time perspective: Prospective
measure: Differences in the color of nail polish
time frame: 30 minutes
description: The photographs showing if there is the reaction of color of nail polish will be assessed after study completion by independent observers. They will be asked to compare the colors of nail polish before and after block performance in both hands and to rate the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference).
intervention type: Other
intervention name: color change in nail polish
description: The determination of color change in nail polish will be based on differences in skin temperature before and after the block.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ali Sait Kavakli, MD
role: Study Director
affiliation: Antalya Training and Research Hospital
last name: Ulku Arslan, MD
role: Principal Investigator
affiliation: Karabuk University
last name: Ferhat Enginar, MD
role: Principal Investigator
affiliation: Antalya Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Body Temperature Changes