Study of Pterygopalatine Fossa Nerve Block Using Ropivacaine and Dexamethasone to Treat Acute Headache After Aneurysmal Subarachnoid Hemorrhage
Led by University of Florida · Updated on 2026-07-06
195
Participants Needed
13
Research Sites
6 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating bilateral pterygopalatine fossa PPF injections using a combination of 20mg ropivacaine and 4mg dexamethasone compared to saline placebo for treating headaches in survivors of aneurysmal subarachnoid hemorrhage SAH. This phase II, multicenter, randomized, double-blinded, placebo-controlled trial uses a sequential parallel comparison design to assess the interventions effects while monitoring intracranial arterial flow using transcranial Doppler TCD during the intervention period.
Participants are randomly assigned to one of three groups Group 1 receives active PPF nerve blocks in both stages, Group 2 receives a placebo injection in the first stage followed by an active PPF nerve block in the second stage, and Group 3 receives placebo injections in both stages. The active nerve block consists of 20mg ropivacaine plus 4mg dexamethasone, while placebo injections consist of normal saline. The trial involves two stages of double-blinded treatment over 48 hours.
During the study, participants are monitored for efficacy, safety, and tolerability outcomes within 24 to 48 hours after each PPF injection. Researchers assess headache relief and measure intracranial arterial flow velocities using TCD. Participants must be able to communicate their pain scores using an 11-point scale. The study lasts until the primary completion date with ongoing monitoring of treatment responses and adverse effects.
CONDITIONS
Brief Title
BLOCK-SAH - PPF-Block for Post-SAH Headache
Research Team
Y
Yurerkis Montas
R
Ralisa Pop
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Active PPF‑block
Placebo PPF‑injection
Standard care
What it is
Injection of a PPF nerve block using ropivacaine plus dexamethasone
Injection of a placebo PPF block using normal saline
First‑line acetaminophen with cautious opioid use for severe headache after SAH
Role in trial
Investigational active treatment period
Double‑blinded placebo control period
Represents usual acute headache management outside the trial
Primary use
To reduce headache severity and opioid requirements after SAH
Control to assess active block’s effect versus placebo
Manage post‑SAH headache symptoms in routine care
How it is given or performed
PPF injection of ropivacaine plus dexamethasone following aneurysm stabilization
PPF injection of normal saline following aneurysm stabilization
Oral or intravenous acetaminophen dosing and opioids as needed
Evidence status
Effectiveness under investigation in this randomized controlled trial
Placebo comparator; no known efficacy
Established as standard first‑line and second‑line analgesia, though often inadequate for post‑SAH headache
Important risks
Safety being monitored; risk details not yet established
Involves injection risks but saline placebo under investigation
Acetaminophen has well‑known liver risks at high doses; opioids carry sedation and dependence risks
Important limitations
Efficacy and safety unknown pending trial results; sequential design may carry carryover bias
Placebo condition provides necessary control but may affect blinding from injection effects
Standard care often fails to control SAH headache fully and complicates neurologic monitoring due to sedation
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
Signed informed consent by participant or legally authorized representative
Willingness to comply with study procedures and availability for study duration
Male or female aged 18 to 85 years
Admission with spontaneous, non-traumatic subarachnoid hemorrhage within 72 hours of hemorrhage onset
Diagnosis confirmed by subarachnoid pattern of hemorrhage involving specific brain regions and diagnostic imaging
Modified Fisher grade 1 to 4 on initial imaging
Hunt and Hess grade 1 to 3 or World Federation of Neurosurgeons grade 1 to 4 with Glasgow Coma Scale verbal subscore of at least 4
Ability to verbalize pain scores using an 11-point numeric scale
Minimum of 4 hours passed since aneurysm treatment with clipping or coiling
Successful treatment of culprit vascular lesion with at least 90% aneurysm obliteration
Requirement of at least 15 mg oral morphine equivalents per day for headache analgesia during eligibility period
You will not qualify if you...
Pre-existing neurologic, psychiatric, or other conditions interfering with neurologic or functional assessment
Pre-existing diffuse narrowing of arteries in the Circle of Willis
Prior opioid or barbiturate use for at least two-thirds of days in the previous month
Substance use disorder diagnosed within the past year
Skin infection or lesion at the injection site
Uncorrected coagulopathy including platelet count below 50,000/µL or INR above 1.7
Requirement for systemic anticoagulation or antiplatelet therapy except aspirin alone
Subarachnoid hemorrhage caused by head trauma or infection
Inability to successfully treat the vascular lesion
Diffuse vasospasm on diagnostic imaging not due to other causes
Elevated liver enzymes prohibiting acetaminophen use
Participation in another interventional investigational study
Known pregnancy or positive pregnancy test
Allergy or intolerance to ropivacaine, dexamethasone, or acetaminophen
Vulnerable populations such as prisoners or inmates
Unable to receive first PPF injection within 96 hours of hemorrhage onset
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Double-Blinded Treatment Phase
Duration - 48 hours
Participants receive two stages of PPF injections, which may be active nerve blocks with ropivacaine and dexamethasone or placebo saline injections, according to their assigned group.
Multiple visits during treatment stages
Monitoring and Assessment
Duration - 48 hours after first injection
Researchers monitor headache relief, safety, and tolerability outcomes and measure intracranial arterial flow velocities using transcranial Doppler during and after treatment.
Regular assessments during this period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Effects of Supervised Aerobic Exercise and Pain Neuroscience Education on Sensory, Musculoskeletal, and Psychosocial Factors in Women with Migraine Aged 18 to 48
Study of AI Software for Detecting and Predicting Stability of Unruptured Cerebral Aneurysms Using Non-Invasive Imaging
Evaluating Medrol Dose Pack for Treating Post-Concussion Headaches in Adults
Studying Enhanced Kidney Clearance in Adults with Serious Brain Illnesses
in Neuroscience Intensive Care Units
Study of Pterygopalatine Fossa Nerve Block Using Ropivacaine and Dexamethasone to Treat Acute Headache After Aneurysmal Subarachnoid Hemorrhage
Study of Combined Transcranial Magnetic Stimulation and Telehealth Therapy for Managing Mild Traumatic Brain Injury Related Headaches in Adults 18 to 65
A Phase II Study of C1 Esterase Inhibitor Cinryze for Treatment of Aneurysmal Subarachnoid Hemorrhage to Reduce Brain Inflammation and Improve Outcomes
Pilot Study Testing CRISP Program for Adults 18 to 29 With Ongoing Concussion Symptoms and Headache
Pilot Study of a Virtual Behavioral Program to Manage Chronic Migraine and Its Effects
Study Comparing Headache Features in Adults With Cervicogenic Headache Based on Flexion-Rotation Test Results
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design.
Katharina M Busl, Cameron R Smith, Andrea B Troxel...