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

NCT ID: NCT00329732

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-04-30

Brief Summary

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine/Bupivicaine

Group Type: ACTIVE_COMPARATOR

0.5% bupivicaine and 2% lidocaine

Intervention Type: DRUG

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

saline

matching volume of saline injected

Group Type: PLACEBO_COMPARATOR

Saline placebo

Intervention Type: DRUG

matching volume of saline (placebo)

Interventions

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

Intervention Type: DRUG

Saline placebo

matching volume of saline (placebo)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Jefferson University

Principal Investigators

William B Young, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jefferson Headache Center

Locations

Jefferson Headache Center/Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

GON-DBPC/WBY

Identifier Type: -

Identifier Source: org_study_id