Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks

Thomas Jefferson University

Status: Terminated

Conditions: Migraine

Treatments: Drug: Saline placebo; Drug: 0.5% bupivicaine and 2% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00329732

GON-DBPC/WBY

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Lidocaine/Bupivicaine

Active Comparator group

Treatment:

Drug: 0.5% bupivicaine and 2% lidocaine

saline

Placebo Comparator group

Description:

matching volume of saline injected

Treatment:

Drug: Saline placebo