<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/NCT02188394</url>
  </required_header>
  <id_info>
    <org_study_id>HCSC11/263</org_study_id>
    <nct_id>NCT02188394</nct_id>
  </id_info>
  <brief_title>Anesthetic Blockades and Migraine</brief_title>
  <official_title>Effects of Anesthetic Blockades on Pain Modulation in Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>César Fernández-de-las-Peñas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of&#xD;
      headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The&#xD;
      aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic&#xD;
      blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs)&#xD;
      in different areas. We hypothesize that those patients receiving real GON anesthetic blockade&#xD;
      will receive greater improvements in pain nociception. We will conduct a double-blind,&#xD;
      randomized, parallel and placebo-controlled clinical trial where one group will be treated&#xD;
      with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the number of days with moderate/intense migraine</measure>
    <time_frame>Baseline (1 week before) and 1 week after intervention</time_frame>
    <description>A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the number of days with mild/moderate migraine</measure>
    <time_frame>Baseline (1 week before) and 1 week after intervention</time_frame>
    <description>A headache diary will register the number of days with mild/moderate migraine. Moderate/intense migraine is considered a headache with an intensity level under 4 points on a numerical pain rate scale (NPRS, 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the number of symptomatic medication drugs</measure>
    <time_frame>Baseline (1 week before) and 1 week after intervention</time_frame>
    <description>The subjects will register in the headache diary the number of days per week in which they need symptomatic medical drugs for relief the headache attack</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pressure pain thresholds</measure>
    <time_frame>Baseline, 1 hour after and 1 week after intervention</time_frame>
    <description>Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Chronic Migraine</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Anesthetic blockades with bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotonic saline injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive a bilateral occipital injection with isotonic saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anesthetic blockades with bupivacaine</intervention_name>
    <arm_group_label>Anesthetic blockades with bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isotonic saline injection</intervention_name>
    <arm_group_label>Isotonic saline injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic migraine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other primary headaches&#xD;
&#xD;
          -  Other secondary headaches&#xD;
&#xD;
          -  Co-morbid medical diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Luz Cuadrado, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinico San Carlos-Universidad Complutense de Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>January 3, 2016</last_update_submitted>
  <last_update_submitted_qc>January 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>César Fernández-de-las-Peñas</investigator_full_name>
    <investigator_title>Proffesor</investigator_title>
  </responsible_party>
  <keyword>migraine,</keyword>
  <keyword>pressure pain,</keyword>
  <keyword>anesthetic blocks</keyword>
  <keyword>patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Anesthetics</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/NCT02188394
org study id: HCSC11/263
nct id: NCT02188394
lead sponsor: 
has dmc: Yes
Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of
      headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The
      aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic
      blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs)
      in different areas. We hypothesize that those patients receiving real GON anesthetic blockade
      will receive greater improvements in pain nociception. We will conduct a double-blind,
      randomized, parallel and placebo-controlled clinical trial where one group will be treated
      with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with
      placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes in the number of days with moderate/intense migraine
time frame: Baseline (1 week before) and 1 week after intervention
description: A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10)
measure: Changes in the number of days with mild/moderate migraine
time frame: Baseline (1 week before) and 1 week after intervention
description: A headache diary will register the number of days with mild/moderate migraine. Moderate/intense migraine is considered a headache with an intensity level under 4 points on a numerical pain rate scale (NPRS, 0-10)
measure: Changes in the number of symptomatic medication drugs
time frame: Baseline (1 week before) and 1 week after intervention
description: The subjects will register in the headache diary the number of days per week in which they need symptomatic medical drugs for relief the headache attack
measure: Changes in pressure pain thresholds
time frame: Baseline, 1 hour after and 1 week after intervention
description: Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle
arm group label: Anesthetic blockades with bupivacaine
arm group type: Experimental
description: Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%
arm group label: Isotonic saline injection
arm group type: Placebo Comparator
description: Patients will receive a bilateral occipital injection with isotonic saline
intervention type: Drug
intervention name: Anesthetic blockades with bupivacaine
arm group label: Anesthetic blockades with bupivacaine
intervention type: Drug
intervention name: Isotonic saline injection
arm group label: Isotonic saline injection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Maria Luz Cuadrado, MD; PhD
role: Principal Investigator
affiliation: Hospital Clinico San Carlos-Universidad Complutense de Madrid
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Proffesor
mesh term: Migraine Disorders
mesh term: Bupivacaine
mesh term: Anesthetics