Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07294118
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.
Study:
NCT07294118
Study Brief:
Protocol Section:
NCT07294118