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NCT07116408 · ClinicalTrials.gov registry record · Phase 4
Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage
A Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH), sponsored by Wright State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07116408 is a Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH) that is actively recruiting participants, run by Wright State University. The registered enrollment target is 20 participants, below the 155-participant average among 35 other Headache trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07116408, a Phase 4 study of Headache and Aneurysmal Subarachnoid Hemorrhage (aSAH), is actively recruiting participants, sponsored by Wright State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
In patients with bleeding from a brain aneurysm, severe headache is the most common complaint. However, the pain is difficult to treat. The use of standard pain medications is common, but pain control remains poor. Additionally, pain medicines have multiple side effects including sedation, interference with breathing, intestinal cramping, low blood pressure, and the risk of addiction. In the present study, the investigators will examine the use of a medication to block the sphenopalatine ganglion which is a bundle of nerves that includes nerves that cause head pain. This block is performed by spraying numbing medication into the back of the nasal cavity on both sides. This particular pain medication does not have the side effects discussed above. The purpose of the study is to see if this treatment will decrease pain without causing unwanted side effects. All patients in the study will receive standard pain medicine as needed for headache. Information will be collected from the patient's medical chart on the amount of pain medication used and the amount of pain the patient describes having. The average pain will be calculated for the first 24 hours the patient is in the hospital. At that point, the patient will receive pain medication sprayed into the back of the nasal cavity on both sides. Patients will also receive this treatment 3 days later. Following these treatments, information will be obtained on the average amount of pain, and how much other pain medication is used. The investigators will look at the amount of pain and the amount of other pain medicine used over the first 24 hours before the nasal pain medicine treatment and compare it to the time after the treatments to see if the amount of pain decreases and if the amount of other pain medicine needed decreases as well. Six months after discharge, the patient will be contacted by phone to find out more information about how much head pain they had after discharge from the hospital.
Conditions Studied
Interventions
- DRUG Lidocaine (drug)
- DEVICE Tx 360
Study Locations (1)
Ohio
- Miami Valley Hospital - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-05-20 |
| Est. Completion | 2027-05 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07116408
The ClinicalTrials.gov registry entry for NCT07116408 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 35 other Headache trials with a reported enrollment target (87% lower). The listed sponsor is Wright State University, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Headache appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine (drug) is the first listed.
NCT07116408 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT07116408 about?
NCT07116408 is a clinical study titled "Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage". In patients with bleeding from a brain aneurysm, severe headache is the most common complaint. However, the pain is difficult to treat. The use of standard pain medications is common, but pain control remains poor. Additionally, pain medicines have multiple side effects including sedation, interfere...
What is the current status of trial NCT07116408?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-05-20. Estimated completion is 2027-05.
What conditions does trial NCT07116408 study?
This clinical trial studies the following conditions: Headache, Aneurysmal Subarachnoid Hemorrhage (aSAH).
What interventions are being tested in trial NCT07116408?
The interventions under investigation include: Lidocaine (drug) (DRUG), Tx 360 (DEVICE).
Who is sponsoring clinical trial NCT07116408?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07116408 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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