NCT06008795

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Subarachnoid Hemorrhage, Aneurysmal
• Headache

Interventions

Type	Name	Description
DRUG	Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone	Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
PROCEDURE	Placebo Pteryogpalatine Fossa Injection	Each placebo PPF-injection will consist of 5ml normal saline

Timeline

• Start date: 2023-12-17
• Primary completion: 2027-01-15
• Completion: 2027-02-28
• First posted: 2023-08-24
• Last updated: 2025-11-28

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study