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

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008795

Collaborator

Massachusetts General Hospital (Other), New York University (Other)

195

Enrollment

Arms

40.5

Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage, Aneurysmal Headache	Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone Procedure: Placebo Pteryogpalatine Fossa Injection	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Sequential Parallel Comparison DesignSequential Parallel Comparison Design

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Nov 30, 2026

Anticipated Study Completion Date :

Feb 28, 2027

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone Other Names: Pterygopalatine Fossa Nerve Block
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	Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone Other Names: Pterygopalatine Fossa Nerve Block Procedure: Placebo Pteryogpalatine Fossa Injection Each placebo PPF-injection will consist of 5ml normal saline
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	Procedure: Placebo Pteryogpalatine Fossa Injection Each placebo PPF-injection will consist of 5ml normal saline

Arm

Intervention/Treatment

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

Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

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

Other Names:

Pterygopalatine Fossa Nerve Block

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

Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

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

Other Names:

Pterygopalatine Fossa Nerve Block

Procedure: Placebo Pteryogpalatine Fossa Injection

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

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

Procedure: Placebo Pteryogpalatine Fossa Injection

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

Outcome Measures

Primary Outcome Measures

Primary Efficacy Endpoint [within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period]
prn oral morphine equivalent (OME)/day use
Primary Safety Endpoint [at 48 hours from first PPF-injection (end of double-blinded treatment period)]
incidence of radiographic vasospasm
Primary Tolerability Endpoint [at 24 hours following the first PPF-injection]
rate of acceptance of second PPF-injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥18 and ≤ 85 years
Admitted with a primary diagnosis of spontaneous, non-traumatic, subarachnoid hemorrhage within 48 hours of ictus hemorrhage
Disease-specific inclusion criteria:
Aneurysm identified as culprit of SAH
modified Fisher grade 1-4 (on admission imaging)
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)
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:
Between 4-48 hours from clipping or coiling procedure (whichever applicable)
Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm)
Requiring a minimum of 15mg OME prn during the 24-hour period immediately prior to enrollment

Exclusion Criteria:

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
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, INR > 1.7
requiring use of systemic anticoagulation, ticagrelor or dual antiplatelet therapy

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 angiography (vasospasm defined as: moderate-to-severe arterial narrowing on digital subtraction angiography not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist) 118

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)

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 (acetaminophen)