Greater Occipital Nerve Block Versus Metoclopramide

NCT03269435 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017-8249
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 0-10 Pain Score

  Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour

  one hour

Secondary Outcomes (2)

• Sustained Headache Relief

  48 hours

• Sustained Headache Freedom

  48 hours

Study Arms (2)

Greater Occipital Nerve Block

EXPERIMENTAL

Bilateral greater occipital nerve block with bupivacaine 0.5% \+ Normal saline IV

Procedure: Greater occipital nerve block with bupivacaine

Metoclopramide

ACTIVE COMPARATOR

Metoclopramide 10mg IV \+ Bilateral greater occipital nerve block with normal saline

Drug: Metoclopramide

Interventions

Greater occipital nerve block with bupivacaine PROCEDURE

This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally

Greater Occipital Nerve Block

Metoclopramide DRUG

Metoclopramide 10mg IV will be administered over 15 minutes

Metoclopramide

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-described
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Bupivacaine; Metoclopramide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Results Point of Contact

• Title: Benjamin Friedman
• Organization: Montefiore

befriedm@montefiore.org

718-920-6626

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double dummy design with IV placebo and placebo nerve block
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 31, 2017
• Study Start: November 1, 2017
• Primary Completion: March 21, 2020
• Study Completion: March 21, 2020
• Last Updated: September 22, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)