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Sphenopalatine Nerve Block for Headache Tx360

Primary Purpose

Headache, Migraine

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

Placebo

About this trial

This is an interventional treatment trial for Headache focused on measuring Headache, Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Normal Saline

Arm Description

Bupivicaine .03ml to each nare

normal saline .03 ml to each nare

Outcomes

Primary Outcome Measures

Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale

Secondary Outcome Measures

Categorical Pain Relief

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.

Headache Free at 24 Hours

The percentage of patients that were headache free at 24 hours by follow-up phone conversation.

Full Information

NCT ID

NCT01939314

First Posted

September 3, 2013

Last Updated

July 6, 2015

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT01939314

Brief Title

Sphenopalatine Nerve Block for Headache Tx360

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 Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Migraine

Keywords

Headache, Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine

Arm Type

Active Comparator

Arm Description

Bupivicaine .03ml to each nare

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

normal saline .03 ml to each nare

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Description

Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Categorical Pain Relief

Description

Time Frame

15 minutes from dose

Title

Headache Free at 24 Hours

Description

The percentage of patients that were headache free at 24 hours by follow-up phone conversation.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason T Schaffer, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Sphenopalatine Nerve Block for Headache Tx360

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