Intranasal sphenopalatine ganglion block for headache after a ruptured brain aneurysm
Intranasal Sphenopalatine Ganglion Blockade as a Non-invasive, Opioid-sparing Treatment for Headaches Following Aneurysmal Subarachnoid Hemorrhage
This will test whether spraying a numbing medicine into the back of the nose can reduce severe headache in adults recovering from a ruptured brain aneurysm.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wright State University Academic / other |
| Locations | 1 site (Dayton, Ohio) |
| Trial ID | NCT07116408 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 4 trial tests an intranasal sphenopalatine ganglion (SPG) block using lidocaine delivered via the Tx 360 device to treat headache after aneurysmal subarachnoid hemorrhage. All participants continue to receive standard pain medicines as needed while investigators record pain scores and side effects. The SPG block targets a nerve bundle linked to head pain and has shown benefit in other headache disorders and in a small pilot for SAH-related pain. The goal is to reduce headache intensity and opioid-related side effects without adding new adverse effects.
Who should consider this trial
Good fit: Adults (18+) treated for aneurysmal subarachnoid hemorrhage in the neuro ICU who have Hunt and Hess scores of 0–3, can verbally report headache, and can consent are ideal candidates.
Not a fit: Patients with Hunt and Hess scores of 4–5, lidocaine allergy, pregnancy, certain nasal or bleeding contraindications, inability to consent, prisoners, or other excluded vulnerable groups are not eligible and unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could lessen severe headache and reduce the need for opioid pain medicines, lowering sedation and breathing-related side effects.
How similar studies have performed: Small pilot data and successful use of SPG blockade in cluster and other headache disorders suggest promise, but large randomized evidence specifically for aSAH headaches is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 able to verbally report headache will be considered for inclusion in this study. Exclusion Criteria: * 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.
Where this trial is running
Dayton, Ohio
- Miami Valley Hospital — Dayton, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: John B Terry, MD
- Email: jbterry@premierhealth.com
- Phone: 937-208-4200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.