Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage

Part of paid clinical trials in Dayton, Ohio.

Sponsor
Wright State University
Study ID
NCT07116408
Phase
PHASE4
Status
Recruiting
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Conditions

  • Aneurysmal Subarachnoid Hemorrhage (aSAH)
  • Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine (drug) — DRUG
    Tx 360/lidocaine
  • Tx 360 — DEVICE
    Tx 360 device

Study Details

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.

Key Dates

Start date
May 20, 2024
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Treatment arm

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

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Valley HospitalDaytonOhio45409-

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By research site
Miami Valley Hospital· Dayton, OH

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