Headache, Opiate Dependence, Opioid Use, Subarachnoid Hemorrhage, Aneurysmal
Conditions
Brief 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.
Interventions
DRUGLidocaine
The participants will receive 50 mg of lidocaine.
The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Score | Baseline | The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: no pain (0 mm) and worst imaginable pain (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the no pain anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention | up to 6 months | To measure analgetic use by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention. by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention. |
Countries
United States
Contacts
Primary ContactMatias Costa
Outcome results
None listed