Nerve Block for Subarachnoid Hemorrhage (BLOCK-SAH Trial)

Phase 2

Recruiting

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours after each ppf-injection spanning the 48 hours of double-blinded treatment period

Summary

This trial studies a drug mixture and injections in the head to reduce headache in stroke survivors.

Who is the study for?

This trial is for adults aged 18-85 who've had a non-traumatic subarachnoid hemorrhage (SAH) from a brain aneurysm within the past 48 hours. They must be able to communicate pain levels, have certain scores on neurological scales, and consent to all study procedures.

What is being tested?

The BLOCK-SAH trial tests if injections in the pterygopalatine fossa with ropivacaine and dexamethasone can reduce headache after SAH compared to saline placebo. It's double-blinded, meaning neither participants nor researchers know who gets which treatment.

What are the potential side effects?

Possible side effects of the nerve block could include discomfort at injection site, allergic reactions to medications used (ropivacaine or dexamethasone), and potential changes in blood flow velocities within the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours after each ppf-injection spanning the 48 hours of double-blinded treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours after each ppf-injection spanning the 48 hours of double-blinded treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours after each ppf-injection spanning the 48 hours of double-blinded treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Endpoint

Primary Safety Endpoint

Primary Tolerability Endpoint

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Group 2 - Placebo - ActiveExperimental Treatment2 Interventions

Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase

Group II: Group 1 - Active - ActiveActive Control1 Intervention

Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase

Group III: Group 3 - Placebo - PlaceboPlacebo Group1 Intervention

Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase

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