A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine

Montefiore Medical Center1 site in 1 country28 target enrollmentJuly 1, 2015

ConditionsMigraine

InterventionsGreater occipital nerve block Bupivacaine

DrugsBupivacaine

Overview

Phase: Phase 3
Intervention: Greater occipital nerve block
Conditions: Migraine
Sponsor: Montefiore Medical Center
Enrollment: 28
Locations: 1
Primary Endpoint: Number of Participants Who Achieve Freedom From Headache
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only enrolled if they fail first line therapy with metoclopramide.

Detailed Description

The investigators are testing the following hypothesis: In a population of patients who present to an ED with acute migraine and have been treated with parenteral metoclopramide unsuccessfully, bilateral greater occipital nerve blocks with bupivicaine will provide greater rates of short-term and sustained headache freedom than bupivacaine injected intradermally.

Registry

clinicaltrials.gov

Start Date

July 1, 2015

End Date

January 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Montefiore Medical Center

Responsible Party

Principal Investigator

Benjamin W. Friedman, MD

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

•ED patient with acute migraine or probable migraine
•Fail first line therapy with metoclopramide

Exclusion Criteria

•Can't obtain consent
•Concern for secondary headache
•Skull defect
•Propensity for bleeding
•Overlying infection
•Pregnancy
•Allergy, intolerance study medication

Arms & Interventions

Greater occipital nerve block

Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique

Intervention: Greater occipital nerve block

Sham

Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Number of Participants Who Achieve Freedom From Headache

Time Frame: 30 minutes

Pain assessed using a standard ordinal headache intensity scale, in which subjects describe their headache as "severe", "moderate", "mild", or "none". Those with headache level = none, experience freedom from headache.