Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks - Full Text View

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00329732

Purpose

Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.

40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.

Condition	Intervention
Migraine	Drug: 0.5% bupivicaine and 2% lidocaine

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine Nausea and Vomiting

Drug Information available for: Lidocaine Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Percentage of patients experiencing significant change on a 4 point pain scale at 30 minutes post-injection, active drug versus placebo. Significant change is defined as a change on the 4 point pain scale from moderate or severe to mild

Secondary Outcome Measures:

Secondary measures include:Percentage of subjects achieving a significant change on a 10 point pain scale at 30 minutes post-injection, active drug versus placebo;
Percentage of subjects achieving a significant change on a 100mm visual analogue scale (VAS) at 30 minutes post-injection, active drug versus placebo. Significant change is defined as a greater than or equal to 2cm change.
Difference in the use of additional pain medication during the 24 hours post-injection, active drug versus placebo;
Percentage of subjects achieving resolution of associated symptoms of nausea, vomiting, photophobia, phonophobia, osmophobia, allodynia measured during the first 30 minutes post-injection, active drug versus placebo;
Percentage of subjects with purely frontal headaches who improve compared to percentage of patients with headache pain located anywhere else so long as it is not located only in the frontal region

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine
Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.
Pain must be reported as at least moderate pain level at time of injections

Exclusion Criteria:

A subject is ineligible to participate in this study if he/she satisfies any of the following criteria:

Subjects who have received greater occipital nerve blocks in the past
Subjects who in their own or the investigator’s opinion are unable to describe their symptoms
Subjects who are pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329732

Contacts

Contact: William B. Young, M.D.

215-955-2243

william.b.young@jefferson.edu

Locations

United States, Pennsylvania
Jefferson Headache Center/Thomas Jefferson University	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: William B. Young, M.D.

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

William B Young, M.D.

Jefferson Headache Center

More Information

Study ID Numbers:	GON-DBPC/WBY
Study First Received:	May 24, 2006
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00329732
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Migraine Disorders
Headache
Lidocaine
Central Nervous System Diseases

Bupivacaine
Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 15, 2009