RECRUITING

Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-20
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07116408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Patients under the age of 18 years of age.
  2. * Patients with an allergy to lidocaine.
  3. * Patients from all vulnerable groups.
  4. * Patients with Hunt and Hess scale score of 4-5. (Scale ranges from 0 to 5 with higher numbers indicating more severe symptoms.)
  5. * Patients who are not able to consent.
  6. * Mentally impaired patients that are unable to provide consent.
  7. * Patients that are prisoners.
  8. * Pregnant patients.
  9. * History of recurrent nose bleeds.
  10. * Nasal septal deformity such as cleft lip and palate, choanal atresia (narrowed nasal passages), atrophic rhinitis, rhinitis medicamentosa, septal perforation, nasal/midface trauma.
  11. * Recent nasal/sinus surgery
  12. * Presence of a bleeding disorder (eg., Von Willebrand's disease or hemophilia).
  13. * Severe respiratory distress.
  14. * Presence of angiofibroma, sinus tumor, or granulomatous disease of the nasopharynx.
  15. * Presence of nasal trauma.
  16. * Nasal congestion that has been present more than 10 days, high fever, or abnormal appearance of the nasal mucosa or mucus.

Contacts and Locations

Study Contact

John B Terry, MD
CONTACT
937-208-4200
jbterry@premierhealth.com

Study Locations (Sites)

Miami Valley Hospital
Dayton, Ohio, 45409
United States

Collaborators and Investigators

Sponsor: Wright State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2027-05

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Headache
  • subarachnoid hemorrhage
  • aneurysm

Additional Relevant MeSH Terms

  • Aneurysmal Subarachnoid Hemorrhage (aSAH)
  • Headache