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Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

This study is currently recruiting participants.
Verified September 2016 by Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02665273
First Posted: January 27, 2016
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Montefiore Medical Center
  Purpose
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.

Condition Intervention Phase
Migraine Procedure: Greater occipital nerve block Procedure: Sham Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Headache freedom [ Time Frame: 30 minutes ]
    Pain assessed using the following scale: "severe," "moderate," "mild," or "none"


Secondary Outcome Measures:
  • 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

  • Satisfaction [ 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?


Other Outcome Measures:
  • 0-10 verbal pain score [ Time Frame: 48 hours ]
    0-10 pain scores will be obtained in the ED and after ED discharge


Estimated Enrollment: 78
Study Start Date: July 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Sham
0.5 cc of 0.5% bupivacaine injected intradermally

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665273


Contacts
Contact: Belinda Tavarez 718-920-6626 btavarez@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Belinda Tavarez    718-920-6626    btavarez@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02665273     History of Changes
Other Study ID Numbers: 2015-4754
First Submitted: January 15, 2016
First Posted: January 27, 2016
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents