<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/NCT04467125</url>
  </required_header>
  <id_info>
    <org_study_id>1288589-4</org_study_id>
    <nct_id>NCT04467125</nct_id>
  </id_info>
  <brief_title>Nexplanon Removal: Subcutaneous vs. Topical Lidocaine</brief_title>
  <official_title>Nexplanon Removal: Subcutaneous vs. Topical Lidocaine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard&#xD;
      route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure&#xD;
      and time to removal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain of procedure</measure>
    <time_frame>during procedure</time_frame>
    <description>Using the pain scale the participant is asked to circle the numerical value of pain they had during removal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time to perform procedure</measure>
    <time_frame>procedure</time_frame>
    <description>the medical assistant times the procedure from incision to removal of the device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>How likely to recommend their anesthetic?</measure>
    <time_frame>procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider's sense of ease of removal?</measure>
    <time_frame>procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>EMLA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcutaneous Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eutectic Lidocaine Prilocaine</intervention_name>
    <description>Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.</description>
    <arm_group_label>EMLA</arm_group_label>
    <other_name>EMLA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subcutaneous Lidocaine</intervention_name>
    <description>Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.</description>
    <arm_group_label>Subcutaneous Lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or&#xD;
             any component of EMLA cream Age greater than or equal to 18years English as primary&#xD;
             language Not pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manish Jain, MD</last_name>
    <phone>706-721-2542</phone>
    <email>majain@augusta.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Augusta University Ob/Gyn Resident Continuity Clinic</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manish Jain, MD</last_name>
      <phone>706-721-2542</phone>
      <email>majain@augusta.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Manish Jain</investigator_full_name>
    <investigator_title>Associate Professor, Dept. of Obstetrics and Gynecology</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04467125
org study id: 1288589-4
nct id: NCT04467125
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard
      route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure
      and time to removal.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: pain of procedure
time frame: during procedure
description: Using the pain scale the participant is asked to circle the numerical value of pain they had during removal.
measure: time to perform procedure
time frame: procedure
description: the medical assistant times the procedure from incision to removal of the device.
measure: How likely to recommend their anesthetic?
time frame: procedure
measure: Provider's sense of ease of removal?
time frame: procedure
arm group label: EMLA
arm group type: Experimental
description: Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.
arm group label: Subcutaneous Lidocaine
arm group type: Active Comparator
description: Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.
intervention type: Drug
intervention name: Eutectic Lidocaine Prilocaine
description: Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.
arm group label: EMLA
other name: EMLA
intervention type: Drug
intervention name: Subcutaneous Lidocaine
description: Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.
arm group label: Subcutaneous Lidocaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manish Jain, MD
phone: 706-721-2542
email: majain@augusta.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Manish Jain
investigator title: Associate Professor, Dept. of Obstetrics and Gynecology
mesh term: Lidocaine
mesh term: Prilocaine
mesh term: Lidocaine, Prilocaine Drug Combination
sharing ipd: No