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A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks

NCT ID: NCT03159000

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-06-30

Brief Summary

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Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GONB of lidocaine/bupivacaine

The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.

Group Type EXPERIMENTAL

lidocaine/bupivacaine

Intervention Type COMBINATION_PRODUCT

1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine

Placebo injection of 1/3 saline

The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

1ml of 1/3 saline

Interventions

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Saline

1ml of 1/3 saline

Intervention Type DRUG

lidocaine/bupivacaine

1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.

Exclusion Criteria

* subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William B Young, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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GON/WBY/003

Identifier Type: -

Identifier Source: org_study_id