Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05925478
Collaborator
(none)
10
12
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
Anticipated Study Start Date
:
Jul 1, 2023
Anticipated Primary Completion Date
:
Jul 1, 2024
Anticipated Study Completion Date
:
Jul 1, 2024
Outcome Measures
Primary Outcome Measures
- Opioid consumption [3 days]
- Pain score [3 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. ropivacaine) 2.Patients with unsecured aneurysms 3.Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc) 4.Medical treatment for vasospasm including blood pressure/inotropic augmentation 5.Angiographic treatment for vasospasm within 48 hours
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Noah Jouett,
Clinical Fellow,
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT05925478
Other Study ID Numbers:
- STU-2023-0176
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: