Phase 4 N=99 Randomized Quadruple-blind Treatment

Greater Occipital Nerve Block Versus Metoclopramide

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT03269435 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: 0-10 Pain Score — 5.0; 6.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Greater occipital nerve block with bupivacaine (Procedure); Metoclopramide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 0-10 Pain Score	5.0; 6.1	—
SECONDARY Sustained Headache Relief	11; 18	—
SECONDARY Sustained Headache Freedom	3; 7	—

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT03269435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.