Sphenopalatine Nerve Block for Headache Tx360

NCT ID: NCT01939314

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Headache; Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bupivacaine

Bupivicaine .03ml to each nare

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Normal Saline

normal saline .03 ml to each nare

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Interventions

Bupivacaine

Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Intervention Type: DRUG

Placebo

Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Intervention Type: DRUG

Other Intervention Names

Normal Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jason Schaffer

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason T Schaffer, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

Tian Medical Inc.

Identifier Type: OTHER

Identifier Source: secondary_id

TX 360 HA -Schaffer

Identifier Type: -

Identifier Source: org_study_id