Sphenopalatine Nerve Block for Headache Tx360

Indiana University

Status and phase: Completed; Phase 3

Conditions: Migraine; Headache

Treatments: Drug: Placebo; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01939314

TX 360 HA -Schaffer

Tian Medical Inc. (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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93 participants in 2 patient groups, including a placebo group

Bupivacaine

Active Comparator group

Description:

Bupivicaine .03ml to each nare

Treatment:

Drug: Bupivacaine

Normal Saline

Placebo Comparator group

Description:

normal saline .03 ml to each nare

Treatment:

Drug: Placebo