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Greater Occipital Nerve Block Versus Metoclopramide

Primary Purpose

Migraine

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Greater occipital nerve block with bupivacaine

Metoclopramide

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:

Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.

Exclusion Criteria:

Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Greater Occipital Nerve Block

Metoclopramide

Arm Description

Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV

Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline

Outcomes

Primary Outcome Measures

0-10 Pain Score

Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour

Secondary Outcome Measures

Sustained Headache Relief

Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication

Sustained Headache Freedom

Headache = none, achieved in emergency department and maintained for 48 hours

Full Information

NCT ID

NCT03269435

First Posted

August 18, 2017

Last Updated

August 25, 2021

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03269435

Brief Title

Greater Occipital Nerve Block Versus Metoclopramide

Official Title

A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

March 21, 2020 (Actual)

Study Completion Date

March 21, 2020 (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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

We are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. This is a randomized, double-blind, double dummy study. The greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.

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 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double dummy design with IV placebo and placebo nerve block

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Greater Occipital Nerve Block

Arm Type

Experimental

Arm Description

Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV

Arm Title

Metoclopramide

Arm Type

Active Comparator

Arm Description

Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline

Intervention Type

Procedure

Intervention Name(s)

Greater occipital nerve block with bupivacaine

Intervention Description

This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally

Intervention Type

Drug

Intervention Name(s)

Metoclopramide

Intervention Description

Metoclopramide 10mg IV will be administered over 15 minutes

Primary Outcome Measure Information:

Title

0-10 Pain Score

Description

Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour

Time Frame

one hour

Secondary Outcome Measure Information:

Title

Sustained Headache Relief

Description

Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication

Time Frame

48 hours

Title

Sustained Headache Freedom

Description

Headache = none, achieved in emergency department and maintained for 48 hours

Time Frame

48 hours

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

self-described

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously. Exclusion Criteria: Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

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

Learn more about this trial

Greater Occipital Nerve Block Versus Metoclopramide

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