Lidocaine and Steroids for Headache

Overseen By Matias Costa

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Medical Branch, Galveston

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if an infusion of lidocaine, with or without steroids, into the middle meningeal artery (MMA) helps relieve severe headaches in patients with spontaneous subarachnoid hemorrhage (SAH). It will also study the safety of this treatment.

Who Is on the Research Team?

Kan Peter, MD

Principal Investigator

University of Texas Medical Branch, Galveston

Are You a Good Fit for This Trial?

This trial is for patients with severe headaches due to spontaneous subarachnoid hemorrhage (SAH). It's aimed at those who may have opioid addiction or dependence, as the treatment could potentially reduce the need for opioids. Specific eligibility criteria are not provided.

Inclusion Criteria

Consent to study procedures and follow-up evaluations

I have a mild to moderate brain aneurysm bleed.

I am 18 years old or older.

Exclusion Criteria

I have a dural arteriovenous fistula.

I do not have major brain disorders.

I have arteriovenous malformations.

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Lidocaine

Trial Overview

The study tests if infusing lidocaine alone, or combined with dexamethasone steroids into the middle meningeal artery can alleviate headache pain in SAH patients. The safety of these treatments is also being evaluated.

How Is the Trial Designed?

Group I: Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) Experimental Treatment 1 Intervention

The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)

Group II: Lidocaine (50 mg bilaterally) Experimental Treatment 1 Intervention

The participants will receive 50 mg of lidocaine.

Group III: No injection (Control group) Active Control 1 Intervention

The participant will not receive an injection.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+