Subarachnoid Hemorrhage, AneurysmalPhase 2NCT07294118
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
A Phase 2 study testing Lidocaine and Lidocaine and Dexamethasone in people with Subarachnoid Hemorrhage, Aneurysmal and Headache, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Headache, Opiate Dependence
- What is being tested?
- Lidocaine and Lidocaine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-2.
- Consent to study procedures and follow-up evaluations.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555-0158
Matias Costa, 409-772-1011, mlcosta@utmb.edu
Peter Kan, MD
About this study
Official title: Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
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.
Read the 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.
- Being tested
- Lidocaine, Lidocaine and Dexamethasone
- Medical subject headings
- Subarachnoid Hemorrhage, Headache, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
The participants will receive 50 mg of lidocaine.
Lidocaine and DexamethasoneDrug
The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine (50 mg bilaterally) | Experimental | The participants will receive 50 mg of lidocaine. Receives: Drug: Lidocaine |
| Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) | Experimental | The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) Receives: Drug: Lidocaine and Dexamethasone |
| No injection (Control group) | No intervention | The participant will not receive an injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Every 4 hours for 24 hours following the procedure
Secondary outcomes (1)
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start2 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kan Peter, MD, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294118
- Sponsor's protocol ID
- 25-0010
- Status last verified
- Jan 2026
- First submitted
- 21 May 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
- ClinicalTrials.gov ID
- NCT07294118
- Acronym / sponsor ID
- 25-0010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine (50 mg bilaterally) | Experimental | Drug: LidocaineThe participants will receive 50 mg of lidocaine. |
| Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) | Experimental | Drug: Lidocaine and DexamethasoneThe participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) |
| No injection (Control group) | No intervention | –The participant will not receive an injection. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-2.
- Consent to study procedures and follow-up evaluations.
Key exclusion criteria (8 listed)
- Known allergies to lidocaine or steroids.
- Arteriovenous malformations.
- Dural Arteriovenous Fistulas.
- Other significant intracranial pathologies.
- Hemodynamic instability preventing safe intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineThe participants will receive 50 mg of lidocaine. | Drug | Lidocaine (50 mg bilaterally) |
| Lidocaine and DexamethasoneThe participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other. | Drug | Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally) |
Primary outcome
Visual Analog Scale (VAS) Score
Time frame: 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.
Visual Analog Scale (VAS) Score
Time frame: Every 4 hours for 24 hours following the procedure
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.
1 secondary outcome
Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kan Peter, MD principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and Lidocaine and Dexamethasone in people with Subarachnoid Hemorrhage, Aneurysmal and Headache, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matias Costa (409-772-1011, mlcosta@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.