Skip to main content
OpenTrials
Completed

NCT Number: NCT02665273

Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Greater occipital nerve block

Procedure

Bilateral greater occipital nerve block

Bupivacaine

Drug

0.5 cc of 0.5% bupivacaine injected intradermally

Primary outcomes

  1. Number of Participants Who Achieve Freedom From Headache

    Time frame: 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 outcomes

  1. Sustained Headache Relief

    Time frame: 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

  2. Would Want the Same Treatment Again During a Subsequent Migraine

    Time frame: 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?

Other outcomes

  1. Change in Pain Score Assessed by Verbal Pain Scale (0-10)

    Time frame: 60 minutes

    The numerical scale, 0-10 pain scores will be obtained with 0 being "no pain" and 10 being "the worst pain imaginable."

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2016
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.