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

NCT06008795 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2025-11-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • New York University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-17
Primary Completion
2027-01-15
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008795 on ClinicalTrials.gov