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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine (50 mg bilaterally) | Experimental | The participants will receive 50 mg of lidocaine. |
|
| Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) | Experimental | The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) |
|
| No injection (Control group) | No Intervention | The participant will not receive an injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | The participants will receive 50 mg of lidocaine. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Score | 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. | Baseline |
| Visual Analog Scale (VAS) Score | 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. | Every 4 hours for 24 hours following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matias Costa | Contact | 409-772-1011 | mlcosta@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kan Peter, MD | University of Texas Medical Branch, Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch, Galveston | Recruiting | Galveston | Texas | 77555-0158 | United States |
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| Lidocaine and Dexamethasone |
| Drug |
The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other. |
|
| up to 6 months |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D006261 | Headache |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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