Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07294118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: