Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621329
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study titled 34Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache34 is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion SPG block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage aSAH The study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge
Detailed Description:
The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage It involves 40 participants who meet specific inclusion criteria such as being over 18 years old having a secured aneurysm and the ability to verbalize pain scores Those with conditions like recent nasal or facial trauma allergies to specific anesthetics or pregnancy are excluded
Participants are randomized into two groups one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block The SPG block is administered using a needleless device called the Tx360 which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways
Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block The study also includes safety monitoring to track any adverse effects from the intervention The entire study spans approximately 24 months with individual participation lasting up to four weeks
Participants are randomized into two groups one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block The SPG block is administered using a needleless device called the Tx360 which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways
Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block The study also includes safety monitoring to track any adverse effects from the intervention The entire study spans approximately 24 months with individual participation lasting up to four weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None