BLOCK-SAH - PPF-Block for Post-SAH Headache

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06008795
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Headache
  • Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone — DRUG
    Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
  • Placebo Pteryogpalatine Fossa Injection — PROCEDURE
    Each placebo PPF-injection will consist of 5ml normal saline

Study Details

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)

Key Dates

Start date
Dec 17, 2023
Status verified
May 2025
Primary completion
Jan 15, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
195 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1 - Active - Active
    Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
  • Other: Group 2 - Placebo - Active
    Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
  • Placebo Comparator: Group 3 - Placebo - Placebo
    Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase

Primary Outcome Measure

Primary Efficacy Endpoint [ Time Frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Carolina Maciel, MD MSCR
[email protected]
352-273-5500
Emory UniversityAtlantaGeorgia30322
Christine Spainhour
[email protected]
404-727-1558
Ofer Sadan, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland BaltimoreBaltimoreMaryland21201
David Oriko
[email protected]
410-328-7822
Nicholas Morris, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55009
Narayan Kissoon, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CollegeAlbanyNew York12208
Mahtab Sheikh
[email protected]
518-262-5883
Charles Argoff, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CollegeRochesterNew York14642
Tilor Hallquist
[email protected]
585-275-3709
Matthew Bender, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45267
Alexandra Ramirez
[email protected]
513-558-0101
Charles Prestigiacomo, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Sciences UniversityPortlandOregon97239
Sarah Feller
[email protected]
503-494-6233
Ines Koerner, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Danna Smith
[email protected]
215-955-2173
Stavropoula Tjoumakaris, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98104
Do Lim
[email protected]
206-744-9389
Sarah Wahlster, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Jacob Labinski
[email protected]
414-805-2578
Tom Aufderheide, MD (PRINCIPAL_INVESTIGATOR)

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