Nerve Block for Subarachnoid Hemorrhage

(BLOCK-SAH Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Florida

Must be taking: Opioids

Must not be taking: Opioids, Barbiturates, Anticoagulants, Antiplatelets

Disqualifiers: Neurologic, Psychiatric, Substance use, others

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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)

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it excludes those requiring systemic anticoagulation and antiplatelet therapy (except aspirin) and those with prior opioid or barbiturate use. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone for subarachnoid hemorrhage?

The research indicates that nerve blocks in the pterygopalatine fossa are used for managing pain in facial surgeries and headaches, suggesting potential effectiveness in pain management. However, specific data on its use for subarachnoid hemorrhage is not provided.

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Is the pterygopalatine fossa nerve block generally safe for humans?

Research suggests that pterygopalatine fossa nerve blocks, especially when guided by ultrasound, are generally considered safe, though there is a risk of injury to nearby structures like the maxillary artery, which could lead to complications such as bleeding.

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How is the Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone treatment different from other treatments for subarachnoid hemorrhage?

This treatment is unique because it involves a nerve block (a procedure to block pain signals) in the pterygopalatine fossa, which is a specific area in the skull, using a combination of ropivacaine (a local anesthetic) and dexamethasone (a steroid to reduce inflammation). It is administered via an ultrasound-guided approach, which is considered safe and precise, and is different from standard treatments that may not target this specific area or use this combination of drugs.

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Eligibility Criteria

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.

Inclusion Criteria

Provision of signed and dated informed consent form

My aneurysm caused a type of stroke known as SAH.

Modified Fisher grade 1-4 (on admission imaging)

Exclusion Criteria

I cannot take acetaminophen due to a chronic liver condition.

Known to be pregnant, or with a positive pregnancy test

I am allergic or intolerant to ropivacaine, dexamethasone, or acetaminophen.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blinded Treatment

Participants receive bilateral pterygopalatine fossa (PPF) injections with either active PPF-block or placebo, monitored with transcranial Doppler (TCD)

48 hours

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of radiographic vasospasm

4 weeks

Participant Groups

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.

Group I: Group 2 - Placebo - Active Experimental Treatment 2 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 - Active Active Control 1 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 - Placebo Placebo Group 1 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

Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone is already approved in United States for the following indications:

🇺🇸 Approved in United States as PPF Block for:

• Post-SAH Headache

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Jacksonville Jacksonville, FL

Emory University Atlanta, GA

Johns Hopkins University Baltimore, MD

Albany Medical College Albany, NY

More Trial Locations

Who Is Running the Clinical Trial?

University of Florida Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS) Collaborator

New York University Collaborator

Massachusetts General Hospital Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Suprazygomatic Nerve Blocks to the Pterygopalatine Fossa: A Safe Procedure. [2023] Large-scale procedural safety data on pterygopalatine fossa nerve blocks (PPFBs) performed via a suprazygomatic, ultrasound-guided approach are lacking, leading to hesitancy surrounding this technique. The aim of this study was to characterize the safety of PPFB.

2. England pubmed.ncbi.nlm.nih.gov

Comparison of the feasibility and safety of infrazygomatic and suprazygomatic approaches to pterygopalatine fossa using virtual reality. [2023] Injections of local anesthetics into pterygopalatine fossa gained popularity for treating acute and chronic facial pain and headaches. Injury of maxillary artery during pterygopalatine fossa injection can result in pseudoaneurysm formation or acute bleeding. We aimed to identify the optimal approach into pterygopalatine fossa by comparing feasibility and safety of suprazygomatic and two infrazygomatic approaches.

3. United States pubmed.ncbi.nlm.nih.gov

A new method of continuous maxillary nerve block with an indwelling catheter. [2019] We describe continuous maxillary nerve block at the pterygopalatine fossa and investigate the efficacy of this technique for perioperative pain control in oral surgery.

4. Ireland pubmed.ncbi.nlm.nih.gov

Impact of age on the anatomy of the pediatric pterygopalatine fossa and its relationship to the suprazygomatic maxillary nerve block. [2018] The suprazygomatic maxillary nerve block is associated with improved post-operative pain management after select craniofacial surgical procedures. This study's objective is to better define the impact of pediatric facial skeletal growth on techniques for accessing the pterygopalatine fossa (PPF).

5. France pubmed.ncbi.nlm.nih.gov

Anatomical landmarks for maxillary nerve block in the pterygopalatine fossa: A radiological study. [2019] The aim of this study was to describe the anatomical landmarks for maxillary nerve block in the pterygopalatine fossa. The risk of injury to the skull base and maxillary artery was assessed.

6. United States pubmed.ncbi.nlm.nih.gov

A previously undescribed branch of the pterygopalatine ganglion. [2013] Endonasal and infrazygomatic pterygopalatine ganglion (PPG) block for facial pain provides pain relief in a broader area than expected on anatomic grounds. The aim of this study was to search for neural structures in the pterygopalatine fossa (PPF) that could explain unexpected pain relief after PPG blockage.