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

NCT ID: NCT07294118

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2027-08-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lidocaine (50 mg bilaterally)

The participants will receive 50 mg of lidocaine.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

The participants will receive 50 mg of lidocaine.

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

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

Group Type: EXPERIMENTAL

Lidocaine and Dexamethasone

Intervention Type: DRUG

The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.

No injection (Control group)

The participant will not receive an injection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine

The participants will receive 50 mg of lidocaine.

Intervention Type: DRUG

Lidocaine and Dexamethasone

The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kan Peter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Locations

University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matias Costa

Role: CONTACT

mlcosta@utmb.edu

409-772-1011

Facility Contacts

Matias Costa

Role: primary

mlcosta@utmb.edu

409-772-1011

Other Identifiers

25-0010

Identifier Type: -

Identifier Source: org_study_id