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

NCT07294118 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-0010
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) Score

  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.

  Baseline

• Visual Analog Scale (VAS) Score

  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.

  Every 4 hours for 24 hours following the procedure

Secondary Outcomes (1)

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

  up to 6 months

Study Arms (3)

Lidocaine (50 mg bilaterally)

EXPERIMENTAL

The participants will receive 50 mg of lidocaine.

Drug: Lidocaine

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

EXPERIMENTAL

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

Drug: Lidocaine and Dexamethasone

No injection (Control group)

NO INTERVENTION

The participant will not receive an injection.

Interventions

Lidocaine DRUG

The participants will receive 50 mg of lidocaine.

Lidocaine (50 mg bilaterally)

Lidocaine and Dexamethasone DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555-0158, United States

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache; Opioid-Related Disorders

Interventions

Lidocaine; Dexamethasone

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kan Peter, MD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matias Costa

CONTACT

409-772-1011; mlcosta@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: December 19, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (1)