Health TrialsbyHealthPanel

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

ConditionsSubarachnoid Hemorrhage, AneurysmalHeadache
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated ICF by participant or a legally authorized representative (LAR)

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, SAH within 72 hours of ictus hemorrhage

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone

    Drug

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

  • Placebo Pteryogpalatine Fossa Injection

    Procedure/Surgery

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

Treatment groups

195 Participants
are divided into 3 treatment groups
Group A: Group 1 - Active - ActiveActive comparator 1 intervention
Group B: Group 2 - Placebo - ActiveOther 2 interventions
Group C: Group 3 - Placebo - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary Efficacy Endpoint

prn oral morphine equivalent (OME)/day use

Time frame
within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
2

Primary Safety Endpoint

incidence of radiographic vasospasm

Time frame
at 48 hours from first PPF-injection (end of double-blinded treatment period)
3

Primary Tolerability Endpoint

rate of acceptance of second PPF-injection

Time frame
at 24 hours following the first PPF-injection

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Florida

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

New York University

Collaborator

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov
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