A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine
Overview
- Phase
- Phase 4
- Intervention
- Greater occipital nerve block with bupivacaine
- Conditions
- Migraine
- Sponsor
- Montefiore Medical Center
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- 0-10 Pain Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Benjamin W. Friedman, MD
Professor
Montefiore Medical Center
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.
Arms & Interventions
Greater Occipital Nerve Block
Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV
Intervention: Greater occipital nerve block with bupivacaine
Metoclopramide
Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline
Intervention: Metoclopramide
Outcomes
Primary Outcomes
0-10 Pain Score
Time Frame: one hour
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
Secondary Outcomes
- Sustained Headache Freedom(48 hours)
- Sustained Headache Relief(48 hours)