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Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Greater occipital nerve block
Bupivacaine
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Greater occipital nerve block

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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?

Full Information

First Posted
January 15, 2016
Last Updated
July 29, 2020
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02665273
Brief Title
Greater Occipital Nerve Block With Bupivacaine for Acute Migraine
Official Title
A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Greater occipital nerve block
Arm Type
Experimental
Arm Description
Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve
Intervention Type
Procedure
Intervention Name(s)
Greater occipital nerve block
Intervention Description
Bilateral greater occipital nerve block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.5 cc of 0.5% bupivacaine injected intradermally
Primary Outcome Measure Information:
Title
Number of Participants Who Achieve Freedom From Headache
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Sustained Headache Relief
Description
Attaining a headache level of "mild" or "none" within one hour of procedure and maintaining this for 48 hours without use of additional medication
Time Frame
48 hours
Title
Would Want the Same Treatment Again During a Subsequent Migraine
Description
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?
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Change in Pain Score Assessed by Verbal Pain Scale (0-10)
Description
The numerical scale, 0-10 pain scores will be obtained with 0 being "no pain" and 10 being "the worst pain imaginable."
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

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