Lidocaine with or without steroid infusion into the middle meningeal artery for headaches after aneurysmal subarachnoid hemorrhage
Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
This study will try an infusion of lidocaine, with or without a steroid, into the middle meningeal artery to see if it reduces severe headaches and opioid use in adults recovering from aneurysmal subarachnoid hemorrhage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT07294118 on ClinicalTrials.gov |
What this trial studies
This prospective Phase 2 cohort at a single center will enroll 15 adults with aneurysmal SAH (Hunt and Hess grades 1–2) and allocate them among three groups: lidocaine infusion, lidocaine plus dexamethasone infusion, or no infusion during routine cerebral angiography. Pain will be measured with visual analog scores at multiple time points, including immediate postoperative neurochecks, to calculate a cumulative total VAS score, and opioid use will be tracked as morphine milligram equivalents. Safety and procedure-related complications will be monitored closely. Participants will have follow-up visits at 1, 3, and 6 months to record longer-term pain outcomes and adverse events.
Who should consider this trial
Good fit: Adults (age ≥18) with aneurysmal subarachnoid hemorrhage, Hunt and Hess grades 1–2, who can consent and undergo diagnostic cerebral angiography are ideal candidates.
Not a fit: Patients with higher-grade or unstable SAH, contraindications to lidocaine or steroids, prior MMA interventions, need for craniotomy or an external ventricular drain, or other significant intracranial vascular lesions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the treatment could lessen severe post-SAH headaches and reduce patients' need for opioids.
How similar studies have performed: This endovascular MMA infusion approach for post-SAH headache is novel with limited prior data, although regional anesthetic and steroid injections have had mixed results for other headache types.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch, Galveston — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kan Peter, MD — University of Texas Medical Branch, Galveston
- Study coordinator: Matias Costa
- Email: mlcosta@utmb.edu
- Phone: 409-772-1011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.