Sphenopalatine Nerve Block for Headache Tx360

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939314
• Other study ID #: TX 360 HA -Schaffer
• Secondary ID: Tian Medical Inc
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2013
• Last updated: July 6, 2015
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• are 18 - 65 years of age

• present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)

• have a normal neurological exams

Exclusion Criteria:

• are less than 18 years old or greater than 65

• have any focal neurological dysfunction signs or symptoms

• have a posterior/occipital/cervicogenic source predominance of headache

• are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches

• have self treated with pain medication or anti-emetic 4 hours prior to arrival

• have a history of peripheral vascular disease, cancer, or HIV infection

• are known to be pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

Drug:
• Bupivacaine
Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
• Placebo
Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale		15 minutes from dose	No
Secondary	Categorical Pain Relief	Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as "No", "Little", "Some", "A Lot" or "Complete". The table displays the number of participants who identified their pain relief in the categories provided.	15 minutes from dose	No
Secondary	Headache Free at 24 Hours	The percentage of patients that were headache free at 24 hours by follow-up phone conversation.	24 hours	No