xml: <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/NCT06008795</url>
    </required_header>
    <id_info>
      <org_study_id>Pending</org_study_id>
      <nct_id>NCT06008795</nct_id>
    </id_info>
    <brief_title>BLOCK-SAH - PPF-Block for Post-SAH Headache</brief_title>
    <acronym>BLOCK-SAH</acronym>
    <official_title>Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>New York University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Florida</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical&#xD;
        trial with a sequential parallel comparison design (SPCD) of bilateral pterygopalatine fossa&#xD;
        (PPF) injections with 20mg ropivacaine + 4mg dexamethasone (active, PPF-block) compared to&#xD;
        saline (placebo) for headache in survivors of aneurysmal subarachnoid hemorrhage (SAH), while&#xD;
        monitoring intracranial arterial mean flow velocities with transcranial Doppler (TCD)&#xD;
        peri-intervention (intervention = PPF-injections: active or placebo)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2026</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Sequential Parallel Comparison Design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Efficacy Endpoint</measure>
      <time_frame>within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period</time_frame>
      <description>prn oral morphine equivalent (OME)/day use</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Safety Endpoint</measure>
      <time_frame>at 48 hours from first PPF-injection (end of double-blinded treatment period)</time_frame>
      <description>incidence of radiographic vasospasm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Tolerability Endpoint</measure>
      <time_frame>at 24 hours following the first PPF-injection</time_frame>
      <description>rate of acceptance of second PPF-injection</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">195</enrollment>
    <condition>Subarachnoid Hemorrhage, Aneurysmal</condition>
    <condition>Headache</condition>
    <arm_group>
      <arm_group_label>Group 1 - Active - Active</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 - Placebo - Active</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3 - Placebo - Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone</intervention_name>
      <description>Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone</description>
      <arm_group_label>Group 1 - Active - Active</arm_group_label>
      <arm_group_label>Group 2 - Placebo - Active</arm_group_label>
      <other_name>Pterygopalatine Fossa Nerve Block</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Placebo Pteryogpalatine Fossa Injection</intervention_name>
      <description>Each placebo PPF-injection will consist of 5ml normal saline</description>
      <arm_group_label>Group 2 - Placebo - Active</arm_group_label>
      <arm_group_label>Group 3 - Placebo - Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In order to be eligible to participate in this study, an individual must meet all of the&#xD;
          following criteria:&#xD;
  &#xD;
            1. Provision of signed and dated informed consent form&#xD;
  &#xD;
            2. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            3. Male or female, aged ≥18 and ≤ 85 years&#xD;
  &#xD;
            4. Admitted with a primary diagnosis of spontaneous, non-traumatic, subarachnoid&#xD;
               hemorrhage within 48 hours of ictus hemorrhage&#xD;
  &#xD;
            5. Disease-specific inclusion criteria:&#xD;
  &#xD;
                 1. Aneurysm identified as culprit of SAH&#xD;
  &#xD;
                 2. modified Fisher grade 1-4 (on admission imaging)&#xD;
  &#xD;
                 3. Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on admission,&#xD;
                    included only if also fulfilling Glasgow Coma Scale verbal subscore≥4)&#xD;
  &#xD;
                 4. minimum Glasgow Coma Scale verbal subscore of 4 (on screening)&#xD;
  &#xD;
            6. Able to verbalize pain scale scores according to 11-point numeric pain scale&#xD;
  &#xD;
               In order to be enrolled and undergo randomization in this study, an individual must&#xD;
               meet all of the additional criteria:&#xD;
  &#xD;
            7. Stabilization period criteria:&#xD;
  &#xD;
                 1. Between 4-48 hours from clipping or coiling procedure (whichever applicable)&#xD;
  &#xD;
                 2. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of&#xD;
                    aneurysm)&#xD;
  &#xD;
            8. Requiring a minimum of 15mg OME prn during the 24-hour period immediately prior to&#xD;
               enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          An individual who meets any of the following criteria will be excluded from participation&#xD;
          in this study:&#xD;
  &#xD;
            1. Premorbid conditions:&#xD;
  &#xD;
                 -  Pre-existing neurologic, psychiatric, or other condition that would confound&#xD;
                    neurologic assessment or would make difficult/impossible to accurately assess&#xD;
                    neurologic and/or functional outcome&#xD;
  &#xD;
                 -  Prior use of opioid or barbiturate analgesics for at least two-thirds of the days&#xD;
                    in previous month, regardless of indication&#xD;
  &#xD;
                 -  Diagnosis of substance use disorder in the previous year&#xD;
  &#xD;
                 -  Infected or wounded skin, or a skin lesion at the site of puncture for&#xD;
                    PPF-injection&#xD;
  &#xD;
            2. Uncorrected coagulopathy&#xD;
  &#xD;
                 -  platelet count &lt; 50,000/μL, INR &gt; 1.7&#xD;
  &#xD;
                 -  requiring use of systemic anticoagulation, ticagrelor or dual antiplatelet&#xD;
                    therapy&#xD;
  &#xD;
            3. SAH-specific:&#xD;
  &#xD;
                 -  Head trauma as etiology of SAH&#xD;
  &#xD;
                 -  Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)&#xD;
  &#xD;
                 -  Inability to successfully treat culprit vascular lesion&#xD;
  &#xD;
                 -  Diffuse vasospasm on initial diagnostic angiography (vasospasm defined as:&#xD;
                    moderate-to-severe arterial narrowing on digital subtraction angiography not&#xD;
                    attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as&#xD;
                    determined by a neuroradiologist or neurointerventionalist) 118&#xD;
  &#xD;
            4. Standard pain regimen conditions&#xD;
  &#xD;
                 -  Elevation of hepatic enzymes prohibiting use of scheduled acetaminophen (i.e.,&#xD;
                    AST or ALT &gt; 3x upper limit level)&#xD;
  &#xD;
                 -  Chronic liver condition with absolute contra-indication for acetaminophen (even&#xD;
                    at lower maximum daily doses)&#xD;
  &#xD;
            5. Participation in a concurrent investigational/interventional study (observational&#xD;
               studies allowed)&#xD;
  &#xD;
            6. Known to be pregnant, or with a positive pregnancy test&#xD;
  &#xD;
            7. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine,&#xD;
               dexamethasone) or standard pain regimen (acetaminophen)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yurerkis Montas</last_name>
      <phone>617-866-9758</phone>
      <email>ymontas@partners.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ralisa Pop</last_name>
      <phone>352-294-5693</phone>
      <email>ralisa.pop@neurology.ufl.edu</email>
    </overall_contact_backup>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pterygopalatine Fossa Nerve Block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Subarachnoid Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008795
  org study id: Pending
  nct id: NCT06008795
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical
        trial with a sequential parallel comparison design (SPCD) of bilateral pterygopalatine fossa
        (PPF) injections with 20mg ropivacaine + 4mg dexamethasone (active, PPF-block) compared to
        saline (placebo) for headache in survivors of aneurysmal subarachnoid hemorrhage (SAH), while
        monitoring intracranial arterial mean flow velocities with transcranial Doppler (TCD)
        peri-intervention (intervention = PPF-injections: active or placebo)
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Sequential Parallel Comparison Design
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Primary Efficacy Endpoint
  time frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
  description: prn oral morphine equivalent (OME)/day use
  measure: Primary Safety Endpoint
  time frame: at 48 hours from first PPF-injection (end of double-blinded treatment period)
  description: incidence of radiographic vasospasm
  measure: Primary Tolerability Endpoint
  time frame: at 24 hours following the first PPF-injection
  description: rate of acceptance of second PPF-injection
  arm group label: Group 1 - Active - Active
  arm group type: Active Comparator
  description: Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
  arm group label: Group 2 - Placebo - Active
  arm group type: Other
  description: Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
  arm group label: Group 3 - Placebo - Placebo
  arm group type: Placebo Comparator
  description: Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase
  intervention type: Drug
  intervention name: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
  description: Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
  arm group label: Group 1 - Active - Active
  arm group label: Group 2 - Placebo - Active
  other name: Pterygopalatine Fossa Nerve Block
  intervention type: Procedure
  intervention name: Placebo Pteryogpalatine Fossa Injection
  description: Each placebo PPF-injection will consist of 5ml normal saline
  arm group label: Group 2 - Placebo - Active
  arm group label: Group 3 - Placebo - Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Yurerkis Montas
  phone: 617-866-9758
  email: ymontas@partners.org
  last name: Ralisa Pop
  phone: 352-294-5693
  email: ralisa.pop@neurology.ufl.edu
  responsible party type: Sponsor
  mesh term: Subarachnoid Hemorrhage
  mesh term: Hemorrhage
  mesh term: Headache
  mesh term: Dexamethasone
  mesh term: Ropivacaine