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Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage

RecruitingPhase 4Ages 18 Years - anyAllWright State University
NCT07116408 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lidocaine (drug)
  • Tx 360
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Where

1 site
Miami Valley Hospital
Dayton, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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