Trials / Recruiting
RecruitingNCT07294118
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- The University of Texas Medical Branch, Galveston · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lidocaine | The participants will receive 50 mg of lidocaine. |
| DRUG | Lidocaine and Dexamethasone | The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other. |
Timeline
- Start date
- 2026-01-02
- Primary completion
- 2027-06-01
- Completion
- 2027-08-01
- First posted
- 2025-12-19
- Last updated
- 2026-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07294118. Inclusion in this directory is not an endorsement.