BridgeMD
New treatment option for Aneurysmal Subarachnoid Hemorrhage (aSAH)
Official title Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage
ClinicalTrials.gov ID: NCT07116408
What this study is testing
What is Lidocaine (drug)?
Lidocaine (drug) is an investigational medicine, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage (asah).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In patients with bleeding from a brain aneurysm, severe headache is the most common complaint. However, the pain is difficult to treat.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 years or older who are being treated in the neurologic ICU for subarachnoid hemorrhage with Hunt and Hess scale of 0-3 (Scale ranges...
You likely can't join if
- Patients under the age of 18 years of age.
- Patients with an allergy to lidocaine.
- Patients from all vulnerable groups.
- Patients with Hunt and Hess scale score of 4-5. (Scale ranges from 0 to 5 with higher numbers indicating more severe symptoms.)
- Patients who are not able to consent.
- Mentally impaired patients that are unable to provide consent.
See the full eligibility criteria
- Patients aged 18 years or older who are being treated in the neurologic ICU for subarachnoid hemorrhage with Hunt and Hess scale of 0-3 (Scale ranges from 0 to 5 with higher numbers indicating more severe symptoms) and...
- Patients under the age of 18 years of age.
- Patients with an allergy to lidocaine.
- Patients from all vulnerable groups.
- Patients with Hunt and Hess scale score of 4-5. (Scale ranges from 0 to 5 with higher numbers indicating more severe symptoms.)
- Patients who are not able to consent.
- Mentally impaired patients that are unable to provide consent.
- Patients that are prisoners.
- Pregnant patients. Additionally, patients with contraindications to use of the Tx 360 device will be excluded. Contraindications include:
- History of recurrent nose bleeds.
- Nasal septal deformity such as cleft lip and palate, choanal atresia (narrowed nasal passages), atrophic rhinitis, rhinitis medicamentosa, septal perforation, nasal/midface trauma.
- Recent nasal/sinus surgery
- Presence of a bleeding disorder (eg., Von Willebrand's disease or hemophilia).
- Severe respiratory distress.
- Presence of angiofibroma, sinus tumor, or granulomatous disease of the nasopharynx.
- Presence of nasal trauma.
- Nasal congestion that has been present more than 10 days, high fever, or abnormal appearance of the nasal mucosa or mucus.
The study team makes the final eligibility decision.
Where it's taking place
- Dayton, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dayton, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.