At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 93 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Bupivacaine and Placebo for Headache and Migraine. Completed, enrolled 93 participants across 1 site.
Detailed 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.
Study Details
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedSep 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedSep 11, 2013
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.8 years ago
Interventions
Bupivacainedrug
Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Placebodrug
Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion