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NCT05925478 Clinical Trial

Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:
Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05925478
Other study ID # STU-2023-0176
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 6, 2023
Est. completion date July 1, 2024

Study information
Verified date January 2024
Source University of Texas Southwestern Medical Center
Contact Noah Jouett, DO/PhD
Phone 214-633-000
Email noah.jouett@utsouthwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ptergyopalatine Fossa Block
Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage
Drug:
• Bupivacaine 0.25% Injectable Solution
Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage

Locations
Country Name City State
United States UT Southwestern Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opioid consumption 3 days
Primary Pain Rating Scale Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain 3 days
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