Recruiting

Sphenopalatine Block

Sponsor:

Wright State University

Code:

NCT07116408

Conditions

Aneurysmal Subarachnoid Hemorrhage (aSAH)

Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine (drug)

Tx 360

Study Details

Brief 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

Aneurysmal Subarachnoid Hemorrhage (aSAH)

Headache

Study ID

NCT07116408

Start date

May 20, 2024

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm

Treatment arm

Interventions

Lidocaine (drug)

Tx 360/lidocaine

Tx 360

Tx 360 device

Primary outcome measure

  • Headache severity [ Time Frame: Day 1 (day of consent) Patient receives first treatment. Pain will be recorded every 8 hours. Second treatment is on day 4. Pain will be recorded every 8 hours until discharge from the ICU, an average of 2 weeks, and at 6 months post discharge. ]

Central Contacts and Locations

Central contacts

Locations

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

More Information

Sponsor

Wright State University

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • Headache
  • subarachnoid hemorrhage
  • aneurysm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wright State University on 2026-05-27.