RECRUITING

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

Conditions

Subarachnoid Hemorrhage, Aneurysmal Headache Pterygopalatine Fossa Nerve Block

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2023-12-17

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06008795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Yurerkis Montas

CONTACT

617-866-9758

ymontas@partners.org

Ralisa Pop

CONTACT

352-294-5693

ralisa.pop@neurology.ufl.edu

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Mayo Clinic

Rochester, Minnesota, 55009

United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-17

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2023-12-17

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

Pterygopalatine Fossa Nerve Block

Additional Relevant MeSH Terms

Subarachnoid Hemorrhage, Aneurysmal
Headache