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Completed

NCT Number: NCT01939314

Sphenopalatine Nerve Block for Headache Tx360

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Placebo

Drug

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

Other names: Normal Saline

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2013
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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