Greater Occipital Nerve Block Versus Metoclopramide

Migraine Clinical Trial

Official title:

A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269435
• Other study ID #: 2017-8249
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: March 21, 2020

Study information

• Verified date: August 2021
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 21, 2020
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-3ß (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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Procedure:
• 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

Drug:
• Metoclopramide
Metoclopramide 10mg IV will be administered over 15 minutes

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	one hour
Secondary	Sustained Headache Relief	Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication	48 hours
Secondary	Sustained Headache Freedom	Headache = none, achieved in emergency department and maintained for 48 hours	48 hours