Subarachnoid Hemorrhage.
Michael K Abraham, Wan-Tsu Wendy Chang
https://pubmed.ncbi.nlm.nih.gov/27741994/Actively Recruiting
Led by Wright State University · Updated on 2026-05-27
20
Participants Needed
1
Research Sites
25 weeks
Total Duration
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 treatments impact and safety.
CONDITIONS
Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage
J
John B Terry, MD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Wright State University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | SPG Block (Tx 360 device + lidocaine) | Standard Pharmacologic Therapy |
|---|---|---|
| What it is | Investigational therapy using a device (Tx 360) to deliver lidocaine intranasally for sphenopalatine ganglion (SPG) blockade, intended to reduce headaches after aneurysmal subarachnoid hemorrhage. | Standard care for post-aSAH headache includes pharmacologic therapy with non-opioid agents (such as acetaminophen) and opioid analgesics as indicated. |
| Primary use | Studied for potential reduction of headache severity in adults hospitalized with subarachnoid hemorrhage. | Used to manage and relieve moderate to severe headache experienced following aSAH. |
| How it is given or performed | Lidocaine is delivered intranasally to the region of the sphenopalatine ganglion via the Tx 360 device, performed at bedside in the neuro ICU. | Non-opioid agents are given by mouth or intravenously; opioids are added for severe pain as needed per clinical judgment. |
| Evidence status | Evidence specific to post-aSAH headache is under investigation; small studies have reported SPG block may relieve other headache types, including acute migraine and cluster headache. Data for aSAH-related headache are limited. | Standard analgesic medicines are routinely used for headache relief after aSAH, though pain may persist or require escalating therapy in some patients. |
| Important limitations | Effectiveness in aSAH headache is not established, as existing evidence is limited to other headache disorders; safety and practical use in this population need further evaluation. | Standard therapies may not always fully relieve headache pain; some patients may require high doses or prolonged use of analgesics, which may be associated with side effects. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Michael K Abraham, Wan-Tsu Wendy Chang
https://pubmed.ncbi.nlm.nih.gov/27741994/Mohamed Binfalah, Eman Alghawi, Eslam Shosha...
https://pubmed.ncbi.nlm.nih.gov/29862074/Athir H Morad, Rafael J Tamargo, Allan Gottschalk
https://pubmed.ncbi.nlm.nih.gov/27704534/R Loch Macdonald, Tom A Schweizer
https://pubmed.ncbi.nlm.nih.gov/27637674/Wright State University
Lead Sponsor