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Sphenopalatine Nerve Block for Headache Tx360

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01939314
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):
Jason Schaffer, Indiana University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01939314

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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Principal Investigator: Jason T Schaffer, MD Indiana University
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Responsible Party: Jason Schaffer, Primary Investigator, Indiana University Identifier: NCT01939314    
Other Study ID Numbers: TX 360 HA -Schaffer
Tian Medical Inc. ( Other Identifier: Tian Medical Inc )
First Posted: September 11, 2013    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Jason Schaffer, Indiana University:
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents