NCT01939314

Sphenopalatine Nerve Block for Headache Tx360

A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.

Conditions

• Headache
• Migraine

Interventions

Type	Name	Description
DRUG	Bupivacaine	Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
DRUG	Placebo	Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-09-11
• Last updated: 2015-07-27
• Results posted: 2015-07-27

Locations

1 site across 1 country: United States