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Procedure

SPG Block for Headaches from Subarachnoid Hemorrhage

Phase 2 & 3

Recruiting

Led By Christine Picinich, MS, AGACNP-BC, CCRN

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Acute subarachnoid hemorrhage

Age greater than 18 years

Must not have

Unsecured aneurysm

Nasal or facial trauma or surgery within the last three months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to icu discharge, up to 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called transnasal sphenopalatine ganglion (SPG) block for headaches in patients with acute subarachnoid hemorrhage (aSAH

Who is the study for?

This trial is for adults over 18 with acute subarachnoid hemorrhage (aSAH) from a secured brain aneurysm, who can express their pain level. A patient or surrogate must consent to participate. It's not suitable for those unable to communicate pain or without decision-making capacity.

What is being tested?

The study tests if a transnasal sphenopalatine ganglion block can better manage headache severity in aSAH patients compared to standard pain meds alone and if it reduces the need for opioids during and after hospital stay.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, nosebleeds due to the nasal passage route of administration, and typical risks associated with local anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a recent bleeding in the brain.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an unsecured aneurysm.

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I have not had nasal or facial surgery or trauma in the last 3 months.

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I am under 18 years old.

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I cannot give consent and have no one to make decisions for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to icu discharge, up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to icu discharge, up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to icu discharge, up to 14 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Numerical pain rating scale

Secondary study objectives

Morphine milligram equivalents (MME)

Other study objectives

Incidence of adverse events related to SPG block procedure

Vasospasm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transnasal SPG Block and Standard of Care MedicationsExperimental Treatment1 Intervention

Intervention arm participants will receive standard of care medications, as defined in a headache protocol, with the addition of transnasal SPG blocks when a predefined threshold is met per the study protocol.

Group II: Standard of Care Medications for HeadacheActive Control1 Intervention

Control arm participants will receive standard of care medications, as defined in a headache protocol, to treat subarachnoid associated headache.

0 / 6Eligibility criteria met