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
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal
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
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
NCT ID
NCT05925478
First Posted
June 21, 2023
Last Updated
September 16, 2023
Sponsor
University of Texas Southwestern Medical Center
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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