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

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Subarachnoid Hemorrhage, Aneurysmal; Opioid Use; Opiate Dependence
• Intervention / Treatment: Drug: Lidocaine; Drug: Lidocaine and Dexamethasone

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matias Costa; Phone Number: 409-772-1011; Email: mlcosta@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555-0158
      • Recruiting
      • University of Texas Medical Branch, Galveston
      • Principal Investigator: Peter Kan, MD
      • Contact: Matias Costa; Phone Number: 409-772-1011; Email: mlcosta@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine (50 mg bilaterally); The participants will receive 50 mg of lidocaine.	Drug: Lidocaine; The participants will receive 50 mg of lidocaine.
Experimental: Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally); The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)	Drug: Lidocaine and Dexamethasone; The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.
No Intervention: No injection (Control group); The participant will not receive an injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	up to 6 months

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Kan Peter, MD, University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Hemorrhage; Substance-Related Disorders; Chemically-Induced Disorders; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Related Disorders; Headache; Subarachnoid Hemorrhage; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; Lidocaine
• Other Study ID Numbers: 25-0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes