Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine, Lidocaine and Dexamethasone.
- Who it may be relevant to
- Registry conditions: Subarachnoid Hemorrhage, Aneurysmal, Headache, Opiate Dependence, Opioid Use. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Visual Analog Scale (VAS) Score [Time frame: Baseline]
- Visual Analog Scale (VAS) Score [Time frame: Every 4 hours for 24 hours following the procedure]
Secondary outcome measures (1)
- Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention [Time frame: up to 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Medical Branch, Galveston — Galveston
Identifiers
NCT: NCT07294118 · 25-0010