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NCT Number: NCT07294118

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

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.

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chemically-Induced Disorders Headache Hemorrhage Intracranial Hemorrhages Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurologic Manifestations Opiate Dependence Opioid Use Opioid-Related Disorders Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Subarachnoid Hemorrhage Substance-Related Disorders Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555-0158, United States

Location status: Recruiting

Location contact

Matias Costa

CONTACT

[email protected]

409-772-1011

Peter Kan, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

The participants will receive 50 mg of lidocaine.

Lidocaine and Dexamethasone

Drug

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

Primary outcomes

  1. Visual Analog Scale (VAS) Score

    Time frame: Baseline

    The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.

  2. Visual Analog Scale (VAS) Score

    Time frame: Every 4 hours for 24 hours following the procedure

    The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.

Secondary outcomes

  1. Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention

    Time frame: up to 6 months

    To measure analgetic use by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention. by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Matias Costa

CONTACT

[email protected]

409-772-1011

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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