A Phase 4 interventional study of Greater occipital nerve block with bupivacaine and Metoclopramide in Migraine, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
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.
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.
Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV
Procedure: Greater occipital nerve block with bupivacaine
Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline
Drug: Metoclopramide
This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
Metoclopramide 10mg IV will be administered over 15 minutes
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
Sustained Headache Relief
Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication
Time frame: 48 hours
Sustained Headache Freedom
Headache = none, achieved in emergency department and maintained for 48 hours
Time frame: 48 hours
| Milestone | Greater Occipital Nerve Block | Metoclopramide |
|---|---|---|
| Started | 51 | 48 |
| Completed | 51 | 48 |
| Not completed | 0 | 0 |
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
| units on a scale | Greater Occipital Nerve Block | Metoclopramide |
|---|---|---|
| 0-10 Pain Score | 5.0 (4.1 to 5.8) | 6.1 (5.2 to 6.9) |
Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication
| Participants | Greater Occipital Nerve Block | Metoclopramide |
|---|---|---|
| Sustained Headache Relief | 11 | 18 |
Headache = none, achieved in emergency department and maintained for 48 hours
| Participants | Greater Occipital Nerve Block | Metoclopramide |
|---|---|---|
| Sustained Headache Freedom | 3 | 7 |
Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Greater Occipital Nerve Block | 0/51 (0%) | 0/51 (0%) | 16/51 (31.4%) |
| Metoclopramide | 0/48 (0%) | 0/48 (0%) | 18/48 (37.5%) |
| Event | Greater Occipital Nerve Block | Metoclopramide |
|---|---|---|
| VariousInvestigations | 1/51 | 9/48 |
| DizzinessNervous system disorders | 4/51 | 3/48 |
| head numbnessInjury, poisoning and procedural complications | 4/51 | 0/48 |
| drowsinessNervous system disorders | 0/51 | 3/48 |
| headacheNervous system disorders | 3/51 | 2/48 |
| Injection site reactionInjury, poisoning and procedural complications | 2/51 | 1/48 |
| Gastrointestinal symptomsGastrointestinal disorders | 2/51 | 0/48 |
| Age, Continuous(years) | Greater Occipital Nerve Block | Metoclopramide | Total |
|---|---|---|---|
| Mean | 39 ± 11 | 38 ± 11 | 39 ± 11 |
| Sex: Female, Male(Participants) | Greater Occipital Nerve Block | Metoclopramide | Total |
|---|---|---|---|
| Female | 44 | 34 | 78 |
| Male | 7 | 14 | 21 |
| Race and Ethnicity Not Collected(Participants) | Greater Occipital Nerve Block | Metoclopramide | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Greater Occipital Nerve Block | Metoclopramide | Total |
|---|---|---|---|
| United States | 51 | 48 | 99 |
| Baseline pain intensity(Participants) | Greater Occipital Nerve Block | Metoclopramide | Total |
|---|---|---|---|
| Severe pain | 38 | 35 | 73 |
| Moderate pain | 13 | 13 | 26 |
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Montefiore Medical Center