Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

Study Overview
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Brief Summary
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This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only enrolled if they fail first line therapy with metoclopramide.

Detailed Description
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The investigators are testing the following hypothesis: In a population of patients who present to an ED with acute migraine and have been treated with parenteral metoclopramide unsuccessfully, bilateral greater occipital nerve blocks with bupivicaine will provide greater rates of short-term and sustained headache freedom than bupivacaine injected intradermally.

Official Title
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A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine

Conditions
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Migraine

Intervention / Treatment
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* Procedure: Greater occipital nerve block
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ED patient with acute migraine or probable migraine Fail first line therapy with metoclopramide Exclusion Criteria: Can't obtain consent Concern for secondary headache Skull defect Propensity for bleeding Overlying infection Pregnancy Allergy, intolerance study medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Greater occipital nerve block<br>Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique | Procedure: Greater occipital nerve block<br>* Bilateral greater occipital nerve block<br>|
| Sham Comparator: Sham<br>Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve | Drug: Bupivacaine<br>* 0.5 cc of 0.5% bupivacaine injected intradermally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieve Freedom From Headache | Pain assessed using a standard ordinal headache intensity scale, in which subjects describe their headache as severe, moderate, mild, or none. Those with headache level = none, experience freedom from headache. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Headache Relief | Attaining a headache level of mild or none within one hour of procedure and maintaining this for 48 hours without use of additional medication | 48 hours | 
| Would Want the Same Treatment Again During a Subsequent Migraine | Participants will be asked the following question: Do you want to receive the same procedure the next time you come to the ER with migraine? | 48 hours |