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Greater Occipital Nerve Block Versus Metoclopramide

This study is not yet open for participant recruitment.
Verified August 2017 by Benjamin Friedman, Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03269435
First Posted: August 31, 2017
Last Update Posted: August 31, 2017
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):
Benjamin Friedman, Montefiore Medical Center
  Purpose
We are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. This is a randomized, double-blind, double dummy study. The greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.

Condition Intervention Phase
Migraine Procedure: Greater occipital nerve block with bupivacaine Drug: Metoclopramide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double dummy design with IV placebo and placebo nerve block
Primary Purpose: Treatment
Official Title: A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine

Resource links provided by NLM:


Further study details as provided by Benjamin Friedman, Montefiore Medical Center:

Primary Outcome Measures:
  • Sustained headache relief [ Time Frame: 48 hours ]
    Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication


Secondary Outcome Measures:
  • Sustained headache freedom [ Time Frame: 48 hours ]
    Headache = none, achieved in emergency department and maintained for 48 hours

  • ED dwell time [ Time Frame: 48 hours ]
    Length of stay in ED: randomization to discharge

  • Improvement in 0-10 pain score [ Time Frame: one hour ]
    Pain score assessed at baseline and one hour


Estimated Enrollment: 170
Anticipated Study Start Date: September 2018
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Greater Occipital Nerve Block

Bilateral greater occipital nerve block with bupivacaine 0.5%

+ Normal saline IV

Procedure: Greater occipital nerve block with bupivacaine
This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
Active Comparator: Metoclopramide

Metoclopramide 10mg IV

+ Bilateral greater occipital nerve block with normal saline

Drug: Metoclopramide
Metoclopramide 10mg IV will be administered over 15 minutes

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-described
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.

Exclusion Criteria:

Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

  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): NCT03269435


Locations
United States, New York
Montefiore Medical Center
The Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Responsible Party: Benjamin Friedman, Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03269435     History of Changes
Other Study ID Numbers: 2017-8249
First Submitted: August 18, 2017
First Posted: August 31, 2017
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
Metoclopramide
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action