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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Greater occipital nerve block | Experimental | Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique |
|
| Sham | Sham Comparator | Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Greater occipital nerve block | Procedure | Bilateral greater occipital nerve block |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score Assessed by Verbal Pain Scale (0-10) | The numerical scale, 0-10 pain scores will be obtained with 0 being "no pain" and 10 being "the worst pain imaginable." | 60 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin W Friedman, MD, MS | Albert Einstein College of Medicine | Principal Investigator |
| 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 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block |
| FG001 | Sham | Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally |
| 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 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block |
| BG001 | Sham |
| 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 | 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. | Posted | Count of Participants | Participants | 30 minutes |
|
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 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin W. 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 | Jun 1, 2015 | Jul 28, 2020 | 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 |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | 0.5 cc of 0.5% bupivacaine injected intradermally |
|
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 |
Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve
Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
| 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 |
|
| Duration of headache | Median | Inter-Quartile Range | hours |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | 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? | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Other Pre-specified | Change in Pain Score Assessed by Verbal Pain Scale (0-10) | The numerical scale, 0-10 pain scores will be obtained with 0 being "no pain" and 10 being "the worst pain imaginable." | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | Sham | Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally | 0 | 15 | 0 | 15 | 2 | 15 |
| neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000588 |
| Amines |