Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

July 29, 2020 updated by: Benjamin W. Friedman, MD, Montefiore Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Greater occipital nerve block
Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique
Procedure: Greater occipital nerve block
Bilateral greater occipital nerve block
Sham Comparator: Sham
Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve
Drug: Bupivacaine
0.5 cc of 0.5% bupivacaine injected intradermally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Headache Relief
Time Frame: 48 hours
Attaining a headache level of "mild" or "none" within one hour of procedure and maintaining this for 48 hours without use of additional medication
48 hours
Would Want the Same Treatment Again During a Subsequent Migraine
Time Frame: 48 hours
Participants will be asked the following question: Do you want to receive the same procedure the next time you come to the ER with migraine?
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score Assessed by Verbal Pain Scale (0-10)
Time Frame: 60 minutes
The numerical scale, 0-10 pain scores will be obtained with 0 being "no pain" and 10 being "the worst pain imaginable."
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College Of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-4754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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