Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 5:33 PM
Study NCT ID:
NCT06008795
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2023-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BLOCK-SAH - PPF-Block for Post-SAH Headache
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
Status:
RECRUITING
Status Verified Date:
2025-05
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01NS124613-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |