Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Galveston 4692883, Texas 4736286 77555-0158
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
Detailed Description
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.