Sphenopalatine Nerve Block for Headache Tx360

• ClinicalTrials.gov Identifier: NCT01939314
• Recruitment Status: Completed
• First Posted: September 11, 2013
• Results First Posted: July 27, 2015
• Last Update Posted: July 27, 2015
• Sponsor: Indiana University
• Information provided by (Responsible Party): Jason Schaffer, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Headache; Migraine	Drug: Bupivacaine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: October 2012
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bupivacaine; Bupivicaine .03ml to each nare	Drug: Bupivacaine; Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Placebo Comparator: Normal Saline; normal saline .03 ml to each nare	Drug: Placebo; Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion; Other Name: Normal Saline

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale [ Time Frame: 15 minutes from dose ]

Secondary Outcome Measures :

1. Categorical Pain Relief [ Time Frame: 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.
2. Headache Free at 24 Hours [ Time Frame: 24 hours ]
   The percentage of patients that were headache free at 24 hours by follow-up phone conversation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Jason T Schaffer, MD; Indiana University

More Information

• Responsible Party: Jason Schaffer, Primary Investigator, Indiana University
• ClinicalTrials.gov Identifier: NCT01939314
• Other Study ID Numbers: TX 360 HA -Schaffer; Tian Medical Inc. ( Other Identifier: Tian Medical Inc )
• First Posted: September 11, 2013
• Results First Posted: July 27, 2015
• Last Update Posted: July 27, 2015
• Last Verified: July 2015

Keywords provided by Jason Schaffer, Indiana University:

Headache; Migraine

Additional relevant MeSH terms:

Headache; Pain; Neurologic Manifestations; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents