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Subarachnoid Hemorrhage, AneurysmalPhase 2BLOCK-SAHNCT06008795

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

A Phase 2 study testing Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone in people with Subarachnoid Hemorrhage, Aneurysmal and Headache, run by University of Florida at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Subarachnoid Hemorrhage, Aneurysmal, Headache
What is being tested?
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
13 sitesUnited States
Study dates
17 Dec 2023to 28 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Premorbid conditions:
  • Pre-existing neurologic, psychiatric, or other condition that would confound neurologic assessment or would make difficult/impossible to accurately assess neurologic and/or functional outcome
  • Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
  • Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
  • Diagnosis of substance use disorder in the previous year
Show all 23Show fewer
  • Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection
  • Uncorrected coagulopathy
  • Platelet count < 50,000/μL, International Normalized Ratio (INR) > 1.7
  • Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).
  • SAH-specific:
  • Head trauma as etiology of SAH
  • Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)
  • Inability to successfully treat culprit vascular lesion
  • Diffuse vasospasm on pre-enrollment diagnostic CTA or DSA. Vasospasm is defined as moderate-to-severe arterial narrowing on DSA or CTA not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist
  • Standard pain regimen conditions
  • Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT > 3x upper limit level)
  • Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)
  • Participation in a concurrent investigational/interventional study (observational studies allowed)
  • Known to be pregnant, or with a positive pregnancy test
  • Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
  • Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
  • Unable to receive first PPF-injection within 96 hours of ictus hemorrhage

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yurerkis Montas contact

617-866-9758

ymontas@partners.org

Ralisa Pop contact

352-294-5693

ralisa.pop@neurology.ufl.edu

13 sites in 1 country

United States13 sites, 13 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Christine Spainhour, 404-727-1558, christine.spainhour@emory.edu

    Ofer Sadan, MD

    Recruiting

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

    David Oriko, 410-328-7822, doriko@som.umaryland.edu

    Nicholas Morris, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Leyla Hatfield, 919-445-2620, hatfieldl@neurology.unc.edu

    Lindsey Krawchuk, MD

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Alexandra Ramirez, 513-558-0101, ramiream@ucmail.uc.edu

    Charles Prestigiacomo, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Carolina Maciel, MD MSCR, 352-273-5500, carolina.maciel@neurology.ufl.edu

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Ana Karen Bolaños, 305-243-3063, axb2916@med.miami.edu

    Nina Massad, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Jacob Labinski, 414-805-2578, jlabinski@mcw.edu

    Tom Aufderheide, MD

    Recruiting

  • Creighton University Medical Center

    Omaha, Nebraska, 68124

    Caroline Nubel, 402-280-4032, CarolineNubel@creighton.edu

    Jason Lambrecht, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Danna Smith, 215-955-2173, danna.smith@jefferson.edu

    Stavropoula Tjoumakaris, MD

    Not yet recruiting

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

    Sarah Feller, 503-494-6233, fellersa@ohsu.edu

    Ines Koerner, MD

    Recruiting

  • University of Rochester Medical College

    Rochester, New York, 14642

    Tilor Hallquist, 585-275-3709, Tilor_Hallquist@URMC.Rochester.edu

    Matthew Bender, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98104

    Do Lim, 206-744-9389, dolim@uw.edu

    Sarah Wahlster, MD

    Recruiting

  • Cleveland Clinic Foundation Martin Health

    Stuart, Florida, 34994

    Irene Ball, 772-763-9317, balli@ccf.org

    Marc Babi, MD

    Recruiting

Other trials in United States

About this study

Official title: Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage

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)

Being tested
Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone, Placebo Pteryogpalatine Fossa Injection
Keywords
Pterygopalatine Fossa Nerve Block
Medical subject headings
Subarachnoid Hemorrhage, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pterygopalatine Fossa Nerve Block with Ropivacaine and DexamethasoneDrug

    Also called Pterygopalatine Fossa Nerve Block

    Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone

  • Placebo Pteryogpalatine Fossa InjectionProcedure or surgery

    Each placebo PPF-injection will consist of 5ml normal saline

Study groups in NCT06008795
Study groupRoleWhat they receive
Group 1 - Active - ActiveActive comparatorSubjects 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
Receives: Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Group 2 - Placebo - ActiveOtherSubjects 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
Receives: Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone; Procedure: Placebo Pteryogpalatine Fossa Injection
Group 3 - Placebo - PlaceboPlacebo comparatorSubjects 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
Receives: Procedure: Placebo Pteryogpalatine Fossa Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Efficacy Endpoint

    prn oral morphine equivalent (OME)/day use

    Measured: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period

  2. Primary Safety Endpoint

    incidence of radiographic vasospasm

    Measured: at 48 hours from first PPF-injection (end of double-blinded treatment period)

  3. Primary Tolerability Endpoint

    rate of acceptance of second PPF-injection

    Measured: at 24 hours following the first PPF-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start17 Dec 2023
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential Parallel Comparison Design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008795
Sponsor's protocol ID
IRB CED000000829
Other IDs
1U01NS124613-01A1
Acronym
BLOCK-SAH
Status last verified
Jun 2026
First submitted
18 Aug 2023
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Busl KM, Smith CR, Troxel AB, Fava M, Illenberger N, Pop R, Yang W, Frota LM, Gao H, Shan G, Hoh BL, Maciel CB; BLOCK-SAH Investigators. Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design. Neurocrit Care. 2025 Feb;42(1):290-300. doi: 10.1007/s12028-024-02078-z. Epub 2024 Aug 13.

    PubMed 39138719

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone in people with Subarachnoid Hemorrhage, Aneurysmal and Headache, run by University of Florida at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yurerkis Montas (617-866-9758, ymontas@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint (time frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008795, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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