Intranasal sphenopalatine ganglion block for headache after a ruptured brain aneurysm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Miami Valley Hospital
  Dayton, Ohio, United States Recruiting

Study contacts

• Study coordinator: John B Terry, MD
• Email: jbterry@premierhealth.com
• Phone: 937-208-4200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.