Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage

NCT07116408 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2022-196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Headache; subarachnoid hemorrhage; aneurysm

Outcome Measures

Primary Outcomes (1)

• Headache severity

  Description of headache severity using headache scale score

  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.

Secondary Outcomes (1)

• Opioid dose

  2 weeks (or duration of hospitalization)

Study Arms (1)

Treatment arm

EXPERIMENTAL

Treatment arm

Drug: Lidocaine (drug); Device: Tx 360

Interventions

Lidocaine (drug) DRUG

Tx 360/lidocaine

Treatment arm

Tx 360 DEVICE

Tx 360 device

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Miami Valley Hospital

Dayton, Ohio, 45409, United States

RECRUITING

Related Publications (4)

• Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.

  PMID: 29862074 BACKGROUND

• Macdonald RL, Schweizer TA. Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.

  PMID: 27637674 BACKGROUND

• Morad AH, Tamargo RJ, Gottschalk A. The Longitudinal Course of Pain and Analgesic Therapy Following Aneurysmal Subarachnoid Hemorrhage: A Cohort Study. Headache. 2016 Nov;56(10):1617-1625. doi: 10.1111/head.12908. Epub 2016 Oct 5.

  PMID: 27704534 BACKGROUND

• Abraham MK, Chang WW. Subarachnoid Hemorrhage. Emerg Med Clin North Am. 2016 Nov;34(4):901-916. doi: 10.1016/j.emc.2016.06.011.

  PMID: 27741994 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache; Aneurysm

Interventions

Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

John B Terry, MD

CONTACT

937-208-4200; jbterry@premierhealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Neurology

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 11, 2025
• Study Start: May 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)