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

Headache Clinical Trial

— BLOCK-SAH  

Official title:

Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008795
• Other study ID #: IRB CED000000829
• Secondary ID: 1U01NS124613-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: December 17, 2023
• Est. completion date: February 28, 2027

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Yurerkis Montas
• Phone: 617-866-9758
• Email: ymontas[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: February 28, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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 informed consent form

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, subarachnoid hemorrhage within 48 hours of ictus hemorrhage

5. Disease-specific inclusion criteria:

1. Aneurysm identified as culprit of SAH

2. Modified Fisher grade 1-4 (on admission imaging)

3. Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on admission, included only if also fulfilling Glasgow Coma Scale verbal subscore=4)

4. 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 clipping or coiling procedure (whichever applicable)

2. Successful treatment of culprit vascular lesion (i.e., =90% obliteration of aneurysm)

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:

• 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

2. 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).

3. 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 initial diagnostic CTA or digital subtraction angiography (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

• Elevation of hepatic enzymes prohibiting use of scheduled acetaminophen (i.e., AST or ALT > 3x upper limit level)

• Chronic liver condition with absolute contra-indication for acetaminophen (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 (acetaminophen)

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

Related Conditions & MeSH terms

• Headache
• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Drug:
• Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone

Procedure:
• Placebo Pteryogpalatine Fossa Injection
Each placebo PPF-injection will consist of 5ml normal saline

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary Safety Endpoint	incidence of radiographic vasospasm	at 48 hours from first PPF-injection (end of double-blinded treatment period)
Primary	Primary Tolerability Endpoint	rate of acceptance of second PPF-injection	at 24 hours following the first PPF-injection