<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/NCT02984618</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 60693416.0.0000.5558</org_study_id>
    <nct_id>NCT02984618</nct_id>
  </id_info>
  <brief_title>Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial</brief_title>
  <official_title>Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brasilia University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brasilia University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch&#xD;
      for post dural puncture headache but the investigators do not know if it has significant&#xD;
      efficacy when compared to epidural blood patch. Method: randomized trial where patients will&#xD;
      randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain&#xD;
      or low intensity pain will be the main outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch&#xD;
      for post dural puncture headache but the investigators do not know if it has significant&#xD;
      efficacy when compared to epidural blood patch. Method: randomized clinical trial where&#xD;
      patients with moderate to severe post dural puncture pain will randomly receive either&#xD;
      sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain&#xD;
      will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus,&#xD;
      low back pain, new dural puncture, sore throat) will be secondary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    High recurrence of headache in SPG group.&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain relief</measure>
    <time_frame>Pain reduction to no pain or low pain within 30 minutes of the intervention.</time_frame>
    <description>Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tinitus</measure>
    <time_frame>Incidence (dichotomic) of tinutus within 24 hours after the procedure.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low back pain</measure>
    <time_frame>Incidence (dichotomic) of low back pain within 24 hours after the procedure.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sore throat</measure>
    <time_frame>Incidence (dichotomic) of sore throat within 24 hours after the procedure.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain relief survival</measure>
    <time_frame>Incidence of new headache onset during the first two weeks</time_frame>
    <description>Patients will be contacted for the first two weeks for monitoring new headache onsets.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Post-Dural Puncture Headache</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive classic epidural blood patch with 20ml of autologous blood</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sphenopalatine ganglion block</intervention_name>
    <description>Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural blood patch</intervention_name>
    <description>Autologous sterile blood (20ml) will be infused in the lombar epidural space.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic criteria for post dural puncture headache&#xD;
&#xD;
          -  Moderate to severe post dural puncture headache&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Procedure failures: new dural puncture on epidural blood patch trial, unable to find&#xD;
             epidural space, intolerance to insertion of nasal swabs.&#xD;
&#xD;
          -  Follow up loss&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel MN Guimaraes, MsC, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade de Brasilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitário de Brasilia</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>70000000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brasilia University Hospital</investigator_affiliation>
    <investigator_full_name>Gabriel Magalhaes Nunes Guimaraes</investigator_full_name>
    <investigator_title>Substitute professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Dural Puncture Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_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/NCT02984618
org study id: CAAE: 60693416.0.0000.5558
nct id: NCT02984618
lead sponsor: 
has dmc: No
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch
      for post dural puncture headache but the investigators do not know if it has significant
      efficacy when compared to epidural blood patch. Method: randomized trial where patients will
      randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain
      or low intensity pain will be the main outcome
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch
      for post dural puncture headache but the investigators do not know if it has significant
      efficacy when compared to epidural blood patch. Method: randomized clinical trial where
      patients with moderate to severe post dural puncture pain will randomly receive either
      sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain
      will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus,
      low back pain, new dural puncture, sore throat) will be secondary outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain relief
time frame: Pain reduction to no pain or low pain within 30 minutes of the intervention.
description: Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.
measure: Tinitus
time frame: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
measure: Low back pain
time frame: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
measure: Sore throat
time frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
measure: Pain relief survival
time frame: Incidence of new headache onset during the first two weeks
description: Patients will be contacted for the first two weeks for monitoring new headache onsets.
arm group label: Treatment group
arm group type: Experimental
description: Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side
arm group label: Control group
arm group type: Active Comparator
description: Patients will receive classic epidural blood patch with 20ml of autologous blood
intervention type: Procedure
intervention name: Sphenopalatine ganglion block
description: Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
arm group label: Treatment group
intervention type: Procedure
intervention name: Epidural blood patch
description: Autologous sterile blood (20ml) will be infused in the lombar epidural space.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel MN Guimaraes, MsC, MD
role: Principal Investigator
affiliation: Universidade de Brasilia
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Brasilia University Hospital
investigator full name: Gabriel Magalhaes Nunes Guimaraes
investigator title: Substitute professor of Anesthesiology
mesh term: Post-Dural Puncture Headache
mesh term: Headache
sharing ipd: No