Recruiting
Phase 2

Lidocaine with Steroids

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07294118

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Headache

Opiate Dependence

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Lidocaine and Dexamethasone

Study Details

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

Subarachnoid Hemorrhage, Aneurysmal

Headache

Opiate Dependence

Opioid Use

Study ID

NCT07294118

Start date

Jan 2, 2026

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lidocaine (50 mg bilaterally)

The participants will receive 50 mg of lidocaine.

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

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

no intervention: No injection (Control group)

The participant will not receive an injection.

Interventions

Lidocaine

The participants will receive 50 mg of lidocaine.

Lidocaine and Dexamethasone

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

Primary outcome measure

  • Visual Analog Scale (VAS) Score [ Time Frame: Baseline ]
  • Visual Analog Scale (VAS) Score [ Time Frame: Every 4 hours for 24 hours following the procedure ]

Central Contacts and Locations

Central contacts

Matias Costa

409-772-1011mlcosta@utmb.edu

Locations

University of Texas Medical Branch, Galveston

Recruiting

Galveston, Texas, United States, 77555-0158

Contacts

Matias Costa

409-772-1011mlcosta@utmb.edu

Principal Investigator:

Peter Kan, MD

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-01-09.