BLOCK-SAH: Treating Headache After Aneurysmal Subarachnoid Hemorrhage
This study, called BLOCK-SAH, is looking at a treatment for headaches that can happen after an aneurysmal subarachnoid hemorrhage (SAH), which is a type of bleeding in the brain. Researchers are testing injections of ropivacaine and dexamethasone into an area called the pterygopalatine fossa (PPF) against a placebo (saline injection). The goal is to see if this "PPF-block" can reduce headache pain. You might be able to join if you are between 18 and 85 years old and have experienced this type of bleeding. The study will measure how well the treatment works and if it's safe and tolerable within 48 hours of the first injection. The current status of the study is unclear, and it plans to enroll 195 participants.
- Study design
- This is a Phase 2, multi-center, randomized, double-blinded, placebo-controlled study with a sequential parallel comparison design, aiming to enroll 195 participants.
- What's involved
- You would receive injections into the pterygopalatine fossa (PPF) and have your brain's blood flow monitored with transcranial Doppler (TCD). The primary efficacy endpoint is measured within 24 hours after each injection, spanning a 48-hour treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety is measured at 48 hours from the first injection, and tolerability is measured at 24 hours following the first injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
BLOCK-SAH - PPF-Block for Post-SAH Headache
At a glance
Conditions
Where it's being run
13 sites across 11 statesWho to contact
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What this trial measures
- Primary Efficacy Endpointwithin 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
prn oral morphine equivalent (OME)/day use
- Primary Safety Endpointat 48 hours from first PPF-injection (end of double-blinded treatment period)
incidence of radiographic vasospasm
- Primary Tolerability Endpointat 24 hours following the first PPF-injection
rate of acceptance of second PPF-injection