Greater Occipital Nerve Block With Bupivacaine for Acute Migraine
A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedResults Posted
Study results publicly available
August 11, 2020
CompletedAugust 11, 2020
July 1, 2020
2.5 years
January 15, 2016
November 7, 2019
July 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Sustained Headache Relief
48 hours
Would Want the Same Treatment Again During a Subsequent Migraine
48 hours
Other Outcomes (1)
Change in Pain Score Assessed by Verbal Pain Scale (0-10)
60 minutes
Study Arms (2)
Greater occipital nerve block
EXPERIMENTALBilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique
Sham
SHAM COMPARATORBilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve
Interventions
Bilateral greater occipital nerve block
Eligibility Criteria
You may qualify if:
- ED patient with acute migraine or probable migraine
- Fail first line therapy with metoclopramide
You may not qualify if:
- Can't obtain consent
- Concern for secondary headache
- Skull defect
- Propensity for bleeding
- Overlying infection
- Pregnancy
- Allergy, intolerance study medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin W. Friedman
- Organization
- Montefiore
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin W Friedman, MD, MS
Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 15, 2016
First Posted
January 27, 2016
Study Start
July 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
August 11, 2020
Results First Posted
August 11, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share