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Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ptergyopalatine Fossa Block
Bupivacaine 0.25% Injectable Solution
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aneurysmal subarachnoid hemorrhage with secured aneurysm Age greater than or equal to 18 years Able to communicate pain level Exclusion Criteria: Documented allergy to local anesthetics (e.g. bupivicaine) Patients with unsecured aneurysms Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc) Medical treatment for vasospasm including blood pressure/inotropic augmentation Angiographic treatment for vasospasm within 48 hours

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Opioid consumption
    Pain Rating Scale
    Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    September 16, 2023
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05925478
    Brief Title
    Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
    Official Title
    Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aneurysmal subarachnoid hemorrhage (aSAH) can cause a severe headache (HA) that is famously treatment-resistant. Current pain regimens are too reliant on opioids, which results in long-term opioid dependence and can obfuscate the neurological examination, which is critical to detect vasospasm and delayed cerebral ischemia. This study will gather the initial evidence of whether the pterygopalatine fossa (PPF) regional anesthesia nerve block can treat aSAH-related HA and reduce opioid consumption in patients with aSAH.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subarachnoid Hemorrhage, Aneurysmal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Ptergyopalatine Fossa Block
    Intervention Description
    Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine 0.25% Injectable Solution
    Intervention Description
    Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage
    Primary Outcome Measure Information:
    Title
    Opioid consumption
    Time Frame
    3 days
    Title
    Pain Rating Scale
    Description
    Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aneurysmal subarachnoid hemorrhage with secured aneurysm Age greater than or equal to 18 years Able to communicate pain level Exclusion Criteria: Documented allergy to local anesthetics (e.g. bupivicaine) Patients with unsecured aneurysms Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc) Medical treatment for vasospasm including blood pressure/inotropic augmentation Angiographic treatment for vasospasm within 48 hours

    12. IPD Sharing Statement

    Learn more about this trial

    Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

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