BLOCK-SAH - PPF-Block for Post-SAH Headache
BLOCK-SAH
Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
2 other identifiers
interventional
195
1 country
11
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2023
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
August 24, 2023
CompletedStudy Start
First participant enrolled
December 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
November 28, 2025
May 1, 2025
3.1 years
August 18, 2023
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Primary Efficacy Endpoint
prn oral morphine equivalent (OME)/day use
within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
Primary Safety Endpoint
incidence of radiographic vasospasm
at 48 hours from first PPF-injection (end of double-blinded treatment period)
Primary Tolerability Endpoint
rate of acceptance of second PPF-injection
at 24 hours following the first PPF-injection
Study Arms (3)
Group 1 - Active - Active
ACTIVE 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
Group 2 - Placebo - Active
OTHERSubjects 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
Group 3 - Placebo - Placebo
PLACEBO 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
Interventions
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
Each placebo PPF-injection will consist of 5ml normal saline
Eligibility Criteria
You may qualify if:
- Spontaneous, non-traumatic SAH
- Subarachnoid pattern of hemorrhage warranting diagnostic DSA due to involvement of at least one of the following regions: quadrigeminal plate, prepontine cistern, perimesencephalic cistern, Sylvian fissure, or surrounding Circle of Willis
- Modified Fisher grade 1-4 (on presentation imaging)
- Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on screening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4)
- Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
- Able to verbalize pain scale scores according to 11-point numeric pain scale
- In order to be enrolled and undergo randomization in this study, an individual must meet all of the additional criteria:
- Stabilization period criteria:
- A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
- Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
- Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- New York Universitycollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (11)
University of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Mayo Clinic
Rochester, Minnesota, 55009, United States
Albany Medical College
Albany, New York, 12208, United States
University of Rochester Medical College
Rochester, New York, 14642, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Washington
Seattle, Washington, 98104, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 39138719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2023
First Posted
August 24, 2023
Study Start
December 17, 2023
Primary Completion (Estimated)
January 15, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
November 28, 2025
Record last verified: 2025-05