Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage

The University of Texas System (UT)

Status and phase: Enrolling; Phase 2

Conditions: Opiate Dependence; Subarachnoid Hemorrhage, Aneurysmal; Opioid Use; Headache

Treatments: Drug: Lidocaine and Dexamethasone; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07294118

25-0010

Details and patient eligibility

About

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.

Full description

This protocol outlines a single-arm prospective cohort study evaluating the efficacy of endovascular infusion of lidocaine and steroids into the MMA for managing post-SAH pain (i.e., headaches) in patients with SAH with Hunt and Hess Grades 1-2. 15 patients will be enrolled into three groups of treatment: lidocaine, lidocaine/dexamethasone, and no injection. Pain outcomes will be evaluated using VAS at multiple timepoints, including during neurochecks postoperatively, to calculate a cumulative "total VAS score." Morphine equivalents will also be tracked to assess opioid needs over time.

The main questions it aims to answer are:

Does the infusion lower patients' pain levels after SAH?

Does the infusion reduce the amount of opioids and other pain medications patients need?

Are there any side effects or complications from the procedure?

Researchers will compare three groups:

Patients who receive lidocaine alone

Patients who receive lidocaine with dexamethasone (a steroid)

Patients who receive no infusion

All participants will:

Undergo a standard brain angiogram (a routine imaging test for SAH)

May receive the medication during the angiogram, depending on their assigned group

Be monitored closely for changes in pain and medication use

Complete follow-up visits at 1, 3, and 6 months to track outcomes and side effects

This study may help find new, targeted ways to treat headaches in patients with SAH and reduce reliance on opioids.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years.
• Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-2.
• Consent to study procedures and follow-up evaluations.

Exclusion criteria

• Known allergies to lidocaine or steroids.
• Arteriovenous malformations.
• Dural Arteriovenous Fistulas.
• Other significant intracranial pathologies.
• Hemodynamic instability preventing safe intervention.
• Previous MMA interventions.
• Previous craniotomies or need for craniotomy.
• Need for external ventricular drain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 3 patient groups

Lidocaine (50 mg bilaterally)

Experimental group

Description:

The participants will receive 50 mg of lidocaine.

Treatment:

Drug: Lidocaine

Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)

Experimental group

Description:

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

Treatment:

Drug: Lidocaine and Dexamethasone

No injection (Control group)

No Intervention group

Description:

The participant will not receive an injection.