Sphenopalatine Nerve Block for Headache Tx360

Phase 3

Completed

• Conditions: Headache; Migraine
• Interventions: Drug: Placebo; Drug: Bupivacaine

• Registration Number: NCT01939314
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-04-15
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-06
• Last Update Submitted: 2015-07-06
• Results First Posted: 2015-07-27
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	normal saline .03 ml to each nare
Bupivacaine	Bupivacaine	Bupivicaine .03ml to each nare

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Categorical Pain Relief	15 minutes from dose	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.
Headache Free at 24 Hours	24 hours	The percentage of patients that were headache free at 24 hours by follow-up phone conversation.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States