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Greater Occipital Nerve Block Versus Metoclopramide

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status and phase

Completed
Phase 4

Conditions

Migraine

Treatments

Drug: Metoclopramide
Procedure: Greater occipital nerve block with bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03269435
2017-8249

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

99 participants in 2 patient groups

Greater Occipital Nerve Block
Experimental group
Description:
Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV
Treatment:
Procedure: Greater occipital nerve block with bupivacaine
Metoclopramide
Active Comparator group
Description:
Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline
Treatment:
Drug: Metoclopramide

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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