NCT06621329

Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The study titled \"Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\" 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.

Conditions

• SAH (Subarachnoid Hemorrhage)
• Headache

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Transnasal sphenopalatine ganglion block	Transnasal sphenopalatine ganglion blocks will be performed using the Tx360 device. Medications used during the procedure include 0.75% bupivacaine with or without 1 mg of preservative free dexamethasone.

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2024-10-01
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study