Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

Phase 3

Completed

• Conditions: Migraine
• Interventions: Procedure: Greater occipital nerve block; Drug: Bupivacaine

• Registration Number: NCT02665273
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Results First Submitted: 2019-11-07
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Results First Posted: 2020-08-11
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Greater occipital nerve block	Greater occipital nerve block	Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique
Sham	Bupivacaine	Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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?

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States