Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

Migraine Clinical Trial

Official title:

A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665273
• Other study ID #: 2015-4754
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Procedure:
• Greater occipital nerve block
Bilateral greater occipital nerve block

Drug:
• Bupivacaine
0.5 cc of 0.5% bupivacaine injected intradermally

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
Other	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
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.	30 minutes
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	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?	48 hours