<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/NCT01704469</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0066</org_study_id>
    <nct_id>NCT01704469</nct_id>
  </id_info>
  <brief_title>A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive&#xD;
      sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but&#xD;
      conflicting. Previous clinical studies mostly used experimental or non-standardized surgical&#xD;
      stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized,&#xD;
      clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-injection pain intensity</measure>
    <time_frame>1 min after lidocaine anesthetic injection</time_frame>
    <description>The local anesthetic injection before main procedure was performed by one pain physician using a 25-gauge needle and 1 ml of 1% lidocaine to raise a small skin wheel. Before and immediately following the injection, patients were asked to rate injection-specific pain and unpleasantness intensity on a 0 to 10 numerical rating scale (NRS).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cancer Patients</condition>
  <arm_group>
    <arm_group_label>The local anesthetic injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The local anesthetic injection</intervention_name>
    <arm_group_label>The local anesthetic injection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20-80&#xD;
&#xD;
          -  cancer patient&#xD;
&#xD;
          -  patient whom receiving opioid treatment, any acute or chronic pain condition amenable&#xD;
             to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic&#xD;
             regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient who has any change in opioid or other analgesic medications less than 14 days&#xD;
             prior to the scheduled procedure&#xD;
&#xD;
          -  an inability to understand English or adequately respond to the relevant questions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 8, 2012</last_update_submitted>
  <last_update_submitted_qc>October 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid induced hyperalgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</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/NCT01704469
org study id: 4-2012-0066
nct id: NCT01704469
lead sponsor: 
has dmc: No
Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive
      sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but
      conflicting. Previous clinical studies mostly used experimental or non-standardized surgical
      stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized,
      clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Post-injection pain intensity
time frame: 1 min after lidocaine anesthetic injection
description: The local anesthetic injection before main procedure was performed by one pain physician using a 25-gauge needle and 1 ml of 1% lidocaine to raise a small skin wheel. Before and immediately following the injection, patients were asked to rate injection-specific pain and unpleasantness intensity on a 0 to 10 numerical rating scale (NRS).
arm group label: The local anesthetic injection group
arm group type: Experimental
intervention type: Procedure
intervention name: The local anesthetic injection
arm group label: The local anesthetic injection group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Anesthetics
mesh term: Anesthetics, Local