Actively Recruiting
Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
Led by The University of Texas Medical Branch, Galveston · Updated on 2026-01-09
15
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether infusing lidocaine, with or without steroids, into the middle meningeal artery (MMA) can help relieve severe headaches in patients who have experienced a spontaneous subarachnoid hemorrhage (SAH). This Phase 2 trial focuses on patients with aneurysmal SAH classified as Hunt and Hess Grades 1-2. The study also aims to assess the safety of this treatment approach and its potential to reduce opioid use for pain management. The study involves three groups of 15 patients each: one group receiving 50 mg of lidocaine alone, another receiving 50 mg of lidocaine combined with 10 mg of dexamethasone (a steroid), and a control group receiving no injection. Medication is given during a standard brain angiogram procedure. Participants will be closely monitored for changes in pain levels and opioid use over time. Participants will undergo multiple pain assessments using the Visual Analog Scale (VAS) at baseline and every 4 hours for 24 hours after the procedure. Morphine equivalent usage will be tracked to evaluate opioid needs. Follow-up visits will occur at 1, 3, and 6 months to monitor ongoing pain relief, medication use, and any side effects or complications. The study duration extends through these follow-ups to gather comprehensive outcome data.
CONDITIONS
Brief Title
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with aneurysmal subarachnoid hemorrhage, Hunt and Hess Grades 1-2
- Consent to study procedures and follow-up evaluations
You will not qualify if you...
- Known allergies to lidocaine or steroids
- Presence of arteriovenous malformations
- Presence of dural arteriovenous fistulas
- Other significant intracranial pathologies
- Hemodynamic instability preventing safe intervention
- Previous middle meningeal artery interventions
- Previous craniotomies or need for craniotomy
- Need for external ventricular drain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus 24 hours post-procedure
Participants undergo a brain angiogram where they may receive an infusion of lidocaine alone, lidocaine with dexamethasone, or no injection. Pain levels and medication use are monitored closely during and immediately after the procedure.
1 procedure visit and monitoring with assessments every 4 hours for 24 hours
Duration - Up to 6 months
Participants complete follow-up visits to track pain outcomes, medication use, and any side effects or complications.
3 visits (at 1, 3, and 6 months post-procedure)
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch, Galveston
Galveston, Texas, United States, 77555-0158
Actively Recruiting
Research Team
M
Matias Costa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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