Migraine
Conditions
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.
Interventions
PROCEDUREGreater 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
DRUGMetoclopramide
Metoclopramide 10mg IV will be administered over 15 minutes
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double dummy design with IV placebo and placebo nerve block
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 0-10 Pain Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Sustained Headache Freedom | 48 hours | Headache = none, achieved in emergency department and maintained for 48 hours |
| Sustained Headache Relief | 48 hours | Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| Metoclopramide Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes | 48 |
| Total | 99 |
Baseline characteristics
| Characteristic | Greater Occipital Nerve Block | Metoclopramide | Total |
|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 11 | 38 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 11 |
| Baseline pain intensity Moderate pain | 13 Participants | 13 Participants | 26 Participants |
| Baseline pain intensity Severe pain | 38 Participants | 35 Participants | 73 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 51 participants | 48 participants | 99 participants |
| Sex: Female, Male Female | 44 Participants | 34 Participants | 78 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 48 |
| other Total, other adverse events | 16 / 51 | 18 / 48 |
| serious Total, serious adverse events | 0 / 51 | 0 / 48 |
Outcome results
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
Time frame: one hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Greater Occipital Nerve Block | 0-10 Pain Score | 5.0 units on a scale |
| Metoclopramide | 0-10 Pain Score | 6.1 units on a scale |
Secondary
Sustained Headache Freedom
Headache = none, achieved in emergency department and maintained for 48 hours
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve Block | Sustained Headache Freedom | 3 Participants |
| Metoclopramide | Sustained Headache Freedom | 7 Participants |
Secondary
Sustained Headache Relief
Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Greater Occipital Nerve Block | Sustained Headache Relief | 11 Participants |
| Metoclopramide | Sustained Headache Relief | 18 Participants |