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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Greater Occipital Nerve Block | Experimental | Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV |
|
| Metoclopramide | Active Comparator | Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Headache Relief | Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication | 48 hours |
| Sustained Headache Freedom | Headache = none, achieved in emergency department and maintained for 48 hours |
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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.
self-described
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Greater Occipital Nerve Block | Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally |
| FG001 | Metoclopramide | Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Greater Occipital Nerve Block | Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | one hour |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Greater Occipital Nerve Block | Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman | Montefiore | 718-920-6626 | befriedm@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2020 | Jul 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Double dummy design with IV placebo and placebo nerve block
| Metoclopramide | Drug | Metoclopramide 10mg IV will be administered over 15 minutes |
|
| 48 hours |
| Metoclopramide |
Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline pain intensity | Count of Participants | Participants |
|
|
|
| Secondary | Sustained Headache Relief | Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Sustained Headache Freedom | Headache = none, achieved in emergency department and maintained for 48 hours | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 16 |
| 51 |
| EG001 | Metoclopramide | Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes | 0 | 48 | 0 | 48 | 18 | 48 |
| drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| head numbness | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injection site reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
|
| Various | Investigations | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |