Greater Occipital Nerve Block Versus Metoclopramide

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03269435
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.6
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Procedure: Greater occipital nerve block with bupivacaine; Drug: Metoclopramide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double dummy design with IV placebo and placebo nerve block
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Mar 21, 2020
• Actual Study Completion Date: Mar 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Greater Occipital Nerve Block Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV	Procedure: Greater occipital nerve block with bupivacaine; This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
Active Comparator: Metoclopramide Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline	Drug: Metoclopramide; Metoclopramide 10mg IV will be administered over 15 minutes

Outcome Measures

Primary Outcome Measures

1. 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

1. Sustained Headache Relief [48 hours]

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

2. Sustained Headache Freedom [48 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 12, 2020

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03269435
• Other Study ID Numbers: 2017-8249
• First Posted: Aug 31, 2017
• Last Update Posted: Sep 22, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Migraine Disorders; Metoclopramide; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Greater Occipital Nerve Block	Metoclopramide
Arm/Group Description	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally	Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
Period Title: Overall Study
STARTED	51	48
COMPLETED	51	48
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Greater Occipital Nerve Block	Metoclopramide	Total
Arm/Group Description	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally	Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes	Total of all reporting groups
Overall Participants	51	48	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (11)	38 (11)	39 (11)
Sex: Female, Male (Count of Participants)
Female	44 86.3%	34 70.8%	78 78.8%
Male	7 13.7%	14 29.2%	21 21.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	51 100%	48 100%	99 100%
Baseline pain intensity (Count of Participants)
Severe pain	38 74.5%	35 72.9%	73 73.7%
Moderate pain	13 25.5%	13 27.1%	26 26.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Greater Occipital Nerve Block	Metoclopramide
Arm/Group Description	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally	Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
Measure Participants	51	48
Mean (95% Confidence Interval) [units on a scale]	5.0	6.1

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Greater Occipital Nerve Block	Metoclopramide
Arm/Group Description	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally	Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
Measure Participants	51	47
Count of Participants [Participants]	11 21.6%	18 37.5%

3. Secondary Outcome

Title	Sustained Headache Freedom
Description	Headache = none, achieved in emergency department and maintained for 48 hours
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Greater Occipital Nerve Block	Metoclopramide
Arm/Group Description	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally	Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
Measure Participants	51	48
Count of Participants [Participants]	3 5.9%	7 14.6%

Adverse Events

Time Frame	48 hours
Arm/Group Title	Greater Occipital Nerve Block		Metoclopramide
Arm/Group Description	Bilateral greater occipital nerve block with bupivacaine 0.5% + Normal saline IV Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally		Metoclopramide 10mg IV + Bilateral greater occipital nerve block with normal saline Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
All Cause Mortality
	Greater Occipital Nerve Block		Metoclopramide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/48 (0%)
Serious Adverse Events
	Greater Occipital Nerve Block		Metoclopramide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Greater Occipital Nerve Block		Metoclopramide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/51 (31.4%)		18/48 (37.5%)
Gastrointestinal disorders
Gastrointestinal symptoms	2/51 (3.9%)	2	0/48 (0%)	0
Injury, poisoning and procedural complications
head numbness	4/51 (7.8%)	4	0/48 (0%)	0
Injection site reaction	2/51 (3.9%)	2	1/48 (2.1%)	1
Investigations
Various	1/51 (2%)		9/48 (18.8%)
Nervous system disorders
Dizziness	4/51 (7.8%)	4	3/48 (6.3%)	3
drowsiness	0/51 (0%)	0	3/48 (6.3%)	3
headache	3/51 (5.9%)	3	2/48 (4.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.