Recruiting
Phase 2

PPF-Block

Sponsor:

University of Florida

Code:

NCT06008795

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Headache

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

Placebo Pteryogpalatine Fossa Injection

Study Details

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)

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Headache

Study ID

NCT06008795

Start date

Dec 17, 2023

Status verified date

Jun, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated ICF by participant or a legally authorized representative (LAR)
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥18 and ≤ 85 years
4. Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage
5. Disease-specific inclusion criteria:

1. Spontaneous, non-traumatic SAH
2. 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
3. Modified Fisher grade 1-4 (on presentation imaging)
4. 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)
5. Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
6. 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:
7. Stabilization period criteria:

1. A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
2. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
8. Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Premorbid conditions:

1. 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
2. Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
3. Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
4. Diagnosis of substance use disorder in the previous year
5. Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection
2. Uncorrected coagulopathy

1. Platelet count < 50,000/μL, International Normalized Ratio (INR) > 1.7
2. Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).
3. SAH-specific:

1. Head trauma as etiology of SAH
2. Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)
3. Inability to successfully treat culprit vascular lesion
4. 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
4. Standard pain regimen conditions

1. Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT > 3x upper limit level)
2. Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)
5. Participation in a concurrent investigational/interventional study (observational studies allowed)
6. Known to be pregnant, or with a positive pregnancy test
7. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
8. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
9. Unable to receive first PPF-injection within 96 hours of ictus hemorrhage

Study Design

Enrollment

195 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

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

Placebo Pteryogpalatine Fossa Injection

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

Primary outcome measure

  • Primary Efficacy Endpoint [ Time Frame: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period ]
  • Primary Safety Endpoint [ Time Frame: at 48 hours from first PPF-injection (end of double-blinded treatment period) ]
  • Primary Tolerability Endpoint [ Time Frame: at 24 hours following the first PPF-injection ]

Central Contacts and Locations

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Nina Massad, MD

Cleveland Clinic Foundation Martin Health

Recruiting

Stuart, Florida, United States, 34994

Contacts

Principal Investigator:

Marc Babi, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Ofer Sadan, MD

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Nicholas Morris, MD

Creighton University Medical Center

Recruiting

Omaha, Nebraska, United States, 68124

Contacts

Principal Investigator:

Jason Lambrecht, MD

University of Rochester Medical College

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Matthew Bender, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Lindsey Krawchuk, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Principal Investigator:

Charles Prestigiacomo, MD

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Principal Investigator:

Ines Koerner, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Sarah Wahlster, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Tom Aufderheide, MD

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

  • Pterygopalatine Fossa Nerve Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.