A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks

Thomas Jefferson University

Overview

Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Migraine

Interventions

SalineDRUG

1ml of 1/3 saline

lidocaine/bupivacaineCOMBINATION_PRODUCT

1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection. Exclusion Criteria: * subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Percentage of subjects experiencing headache improvement at 2 hours

Headache intensity on 4 point pain scale from moderate or severe to mild or none

Time frame: 2 hours

Secondary Outcomes

Percentage of subjects experiencing headache improvement 10 minutes

Headache intensity on 4 point pain scale from moderate or severe to mild or none.

Time frame: 10 minutes

Percentage of subjects experiencing headache improvement at 30 minutes

Headache intensity on 4 point pain scale from moderate or severe to mild or none.

Time frame: 30 minutes

Percentage of subjects experiencing headache improvement at 1 hour

Headache intensity on 4 point pain scale from moderate or severe to mild or none.

Time frame: 1 hour

Percentage of subjects experiencing headache improvement at 24 hours

Headache intensity on 4 point pain scale from moderate or severe to mild or none.

Time frame: 24 hours

Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes

Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia

Time frame: 10 minutes

Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes

Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.