Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Nov 2023
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2024
CompletedAugust 22, 2024
August 1, 2024
10 months
June 21, 2023
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Opioid consumption
3 days
Pain Rating Scale
Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain
3 days
Study Arms (1)
Treatment arm
EXPERIMENTALInterventions
Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage
Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage
Eligibility Criteria
You may qualify if:
- Aneurysmal subarachnoid hemorrhage with secured aneurysm
- Age greater than or equal to 18 years
- Able to communicate pain level
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow Physician
Study Record Dates
First Submitted
June 21, 2023
First Posted
June 29, 2023
Study Start
November 6, 2023
Primary Completion
August 20, 2024
Study Completion
August 20, 2024
Last Updated
August 22, 2024
Record last verified: 2024-08