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

Sponsor:	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 Drug: Saline placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine Nausea and Vomiting

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Lidocaine

U.S. FDA Resources

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. No Pain Equals 0. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

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; [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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; [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment:	2
Study Start Date:	March 2006
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lidocaine/Bupivicaine	Drug: 0.5% bupivicaine and 2% lidocaine 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. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache
Placebo Comparator: saline matching volume of saline injected	Drug: Saline placebo matching volume of saline (placebo)

Arms

Assigned Interventions

Active Comparator: Lidocaine/Bupivicaine

Drug: 0.5% bupivicaine and 2% lidocaine

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. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache

Placebo Comparator: saline

matching volume of saline injected

Drug: Saline placebo

matching volume of saline (placebo)

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

Locations

United States, Pennsylvania
Jefferson Headache Center/Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

William B Young, M.D.

Jefferson Headache Center

More Information

No publications provided

Responsible Party:	Bruce Smith, Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00329732 History of Changes
Other Study ID Numbers:	GON-DBPC/WBY
Study First Received:	May 24, 2006
Results First Received:	May 24, 2011
Last Updated:	July 21, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012