Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07116408

Intranasal Sphenopalatine Ganglion Blockade as a Non-invasive, Opioid-sparing Treatment for Headaches Following Aneurysmal Subarachnoid Hemorrhage

Led by Wright State University · Updated on 2026-05-27

20

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Severe headaches are a common and difficult-to-treat symptom for patients suffering from bleeding caused by a brain aneurysm, known as aneurysmal subarachnoid hemorrhage (aSAH). Standard pain medications often have side effects like sedation, breathing issues, and risk of addiction, and they may not control pain well. Researchers are studying a new approach that involves blocking a nerve bundle called the sphenopalatine ganglion by spraying a numbing medication into the back of the nasal cavity to see if it can reduce headache pain without the usual side effects. In this study, all patients will receive standard pain medication as needed. The new treatment using lidocaine delivered via a Tx 360 device will be sprayed into the back of both sides of the nasal cavity on the first day and again three days later. Researchers will track patients' pain levels and the amount of other pain medication used before and after this nasal treatment to evaluate its effect. The study aims to find out if this treatment decreases headache pain and reduces the need for opioids. Participants will be closely monitored with pain assessments every eight hours starting on the day of consent through discharge from the intensive care unit, usually about two weeks. Six months after leaving the hospital, patients will be contacted by phone to learn about their headache pain since discharge. The study measures headache severity over time and opioid use during hospitalization to understand the treatment's impact and safety.

CONDITIONS

Brief Title

Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Treated in a neurologic ICU for subarachnoid hemorrhage
  • Hunt and Hess scale score of 0-3 (lower severity)
  • Able to verbally report headache pain
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Allergy to lidocaine
  • Belong to vulnerable groups
  • Hunt and Hess scale score of 4-5 (higher severity)
  • Unable to provide consent or mentally impaired
  • Prisoners
  • Pregnant patients
  • History of recurrent nosebleeds
  • Nasal septal deformities or abnormalities
  • Recent nasal or sinus surgery
  • Bleeding disorders like Von Willebrand's disease or hemophilia
  • Severe respiratory distress
  • Presence of nasal tumors or granulomatous diseases
  • Nasal trauma
  • Nasal congestion lasting more than 10 days or abnormal nasal mucosa or mucus appearance
  • Contraindications to use of the Tx 360 device (nasal spray device)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks or duration of hospitalization

Participants receive intranasal sphenopalatine ganglion blockade treatment with lidocaine using the Tx 360 device to help reduce headache severity following aneurysmal subarachnoid hemorrhage.

First treatment on Day 1 with pain recorded every 8 hours; second treatment on Day 4 with pain recorded every 8 hours until ICU discharge

Follow-up

Duration - Up to 6 months post discharge

Participants are monitored for headache severity and opioid use after discharge to evaluate long-term treatment effects.

Pain assessment at 6 months post discharge

Trial Site Locations

Total: 1 location

1

Miami Valley Hospital

Dayton, Ohio, United States, 45409

Actively Recruiting

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Research Team

J

John B Terry, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

The Longitudinal Course of Pain and Analgesic Therapy Following Aneurysmal Subarachnoid Hemorrhage: A Cohort Study.

Athir H Morad, Rafael J Tamargo, Allan Gottschalk

https://pubmed.ncbi.nlm.nih.gov/27704534