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Procedure

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
Awards & highlights

BLOCK-SAH Trial 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.Check my eligibility
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.See study design
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.

BLOCK-SAH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint
Primary Safety Endpoint
Primary Tolerability Endpoint

BLOCK-SAH 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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,451 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,394 Total Patients Enrolled
New York UniversityOTHER
226 Previous Clinical Trials
313,922 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join the research project at this point in time?

"According to the latest report on clinicaltrials.gov, this medical trial is actively inviting volunteers with its inception date set at November 27th 2023 and last edited on November 29th of the same year."

Answered by AI

What is the current scope of this experiment's participant pool?

"Affirmative, the information accessible on clinicaltrials.gov confirms that this trial is actively searching for participants; it was initially posted in November of 2023 and most recently updated a couple days later. 195 patients must be recruited from one medical centre."

Answered by AI

Does this clinical research accept participants of a younger age bracket?

"According to the eligibility requirements, individuals aged between 18 and 85 can enter in this trial. Moreover, 66 clinical trials are available for people under 18 years old while 387 are tailored towards those over 65."

Answered by AI

What potential health risks do patients face when partaking in Group 1 - Active - Active?

"The safety of Group 1 - Active was estimated at 2, since there is some data verifying its safe use but no evidence pointing to a potential efficacy."

Answered by AI

Could I potentially join the research trial?

"This clinical trial is open to 195 participants who have been diagnosed with headache; they must be between the ages of 18 and 85. In order to qualify, individuals must provide signed consent, agree to abide by study requirements for duration of investigation, identify as male or female, possess a SAH diagnosis within 48 hours from ictus hemorrhage, demonstrate modified Fisher grade 1-4 (on admission imaging), Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on admission if additionally meeting Glasgow Coma Scale verbal subscore ≥ 4 criteria), indicate minimum Glasgow Coma Scale verbal subscore of 4 on screening"

Answered by AI
~130 spots leftby Jan 2027