Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

NCT ID: NCT02665273

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2018-01-31

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Greater occipital nerve block

Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique

Group Type: EXPERIMENTAL

Greater occipital nerve block

Intervention Type: PROCEDURE

Bilateral greater occipital nerve block

Sham

Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve

Group Type: SHAM_COMPARATOR

Bupivacaine

Intervention Type: DRUG

0.5 cc of 0.5% bupivacaine injected intradermally

Interventions

Greater occipital nerve block

Bilateral greater occipital nerve block

Intervention Type: PROCEDURE

Bupivacaine

0.5 cc of 0.5% bupivacaine injected intradermally

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin W. Friedman, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin W Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-4754

Identifier Type: -

Identifier Source: org_study_id