Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008795
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-08-18
Brief Title:
BLOCK-SAH - PPF-Block for Post-SAH Headache
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pterygopalatine Fossa PPF Block as an Opioid Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLOCK-SAH
Brief Summary:
BLOCK-SAH is a phase II multicenter randomized double-blinded placebo-controlled clinical trial with a sequential parallel comparison design SPCD of bilateral pterygopalatine fossa PPF injections with 20mg ropivacaine 4mg dexamethasone active PPF-block compared to saline placebo for headache in survivors of aneurysmal subarachnoid hemorrhage SAH while monitoring intracranial arterial mean flow velocities with transcranial Doppler TCD peri-intervention intervention PPF-injections active or placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01NS124613-01A1 | NIH | None | httpsreporternihgovquickSearch1U01NS124613-01A1 |