Migraine
Conditions
Brief summary
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
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.
Interventions
PROCEDUREGreater occipital nerve block
Bilateral greater occipital nerve block
DRUGBupivacaine
0.5 cc of 0.5% bupivacaine injected intradermally
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieve Freedom From Headache | 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Headache Relief | 48 hours | Attaining a headache level of mild or none within one hour of procedure and maintaining this for 48 hours without use of additional medication |
| Would Want the Same Treatment Again During a Subsequent Migraine | 48 hours | 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? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score Assessed by Verbal Pain Scale (0-10) | 60 minutes | The numerical scale, 0-10 pain scores will be obtained with 0 being no pain and 10 being the worst pain imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Greater Occipital Nerve Block | Sham | Total |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 10 | 40 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 11 |
| Duration of headache | 96 hours | 48 hours | 72 hours |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 13 participants | 15 participants | 28 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 3 / 13 | 2 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
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.
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve Block | Number of Participants Who Achieve Freedom From Headache | 4 Participants |
| Sham | Number of Participants Who Achieve Freedom From Headache | 0 Participants |
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
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve Block | Sustained Headache Relief | 3 Participants |
| Sham | Sustained Headache Relief | 0 Participants |
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?
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve Block | Would Want the Same Treatment Again During a Subsequent Migraine | 5 Participants |
| Sham | Would Want the Same Treatment Again During a Subsequent Migraine | 3 Participants |
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.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greater Occipital Nerve Block | Change in Pain Score Assessed by Verbal Pain Scale (0-10) | 3.3 units on a scale | Standard Deviation 2.8 |
| Sham | Change in Pain Score Assessed by Verbal Pain Scale (0-10) | 5.5 units on a scale | Standard Deviation 2.4 |