Greater Occipital Nerve Block Versus Metoclopramide

Phase 4

Completed

• Conditions: Migraine
• Interventions: Procedure: Greater occipital nerve block with bupivacaine; Drug: Metoclopramide

• Registration Number: NCT03269435
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Study Start: 2017-11-01
• Primary Completion: 2020-03-21
• Study Completion: 2020-03-21
• Results First Submitted: 2021-07-13
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Results First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Greater Occipital Nerve Block	Greater occipital nerve block with bupivacaine	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV
Metoclopramide	Metoclopramide	Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline

Primary Outcome Measures

Name	Time	Method
0-10 Pain Score	one hour	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

Name	Time	Method
Sustained Headache Freedom	48 hours	Headache = none, achieved in emergency department and maintained for 48 hours
Sustained Headache Relief	48 hours	Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States