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

Condition(s) targeted: Migraine

Intervention: 0.5% bupivicaine and 2% lidocaine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Thomas Jefferson University

Official(s) and/or principal investigator(s):
William B Young, M.D., Principal Investigator, Affiliation: Jefferson Headache Center

Overall contact:
William B. Young, M.D., Phone: 215-955-2243, Email: william.b.young@jefferson.edu

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.

Official title: Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: 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:

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

William B. Young, M.D., Phone: 215-955-2243, Email: william.b.young@jefferson.edu

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

Last updated: April 26, 2007