Sphenopalatine Nerve Block for Headache Tx360

Last updated: July 6, 2015
Sponsor: Indiana University
Overall Status: Completed

Phase

3

Condition

Oral Facial Pain

Headaches

Pain

Treatment

N/A

Clinical Study ID

NCT01939314
TX 360 HA -Schaffer
Tian Medical Inc.
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • are 18 - 65 years of age

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

  • have a normal neurological exams

Exclusion

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, thenasal 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

Total Participants: 93
Study Start date:
October 01, 2012
Estimated Completion Date:
December 31, 2013

Connect with a study center

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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