A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks

Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks

Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.

Study Overview

• Status: Withdrawn
• Conditions: Migraine
• Intervention / Treatment: Combination product: lidocaine/bupivacaine; Drug: Saline

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.

Exclusion Criteria:

• subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GONB of lidocaine/bupivacaine; The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.	Combination product: lidocaine/bupivacaine; 1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
Placebo Comparator: Placebo injection of 1/3 saline; The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally. The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection. Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.	Drug: Saline; 1ml of 1/3 saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects experiencing headache improvement at 2 hours	Headache intensity on 4 point pain scale from moderate or severe to mild or none	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects experiencing headache improvement 10 minutes	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	10 minutes
Percentage of subjects experiencing headache improvement at 30 minutes	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	30 minutes
Percentage of subjects experiencing headache improvement at 1 hour	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	1 hour
Percentage of subjects experiencing headache improvement at 24 hours	Headache intensity on 4 point pain scale from moderate or severe to mild or none.	24 hours
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	10 minutes
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	30 minutes
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	1 hour
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	2 hours
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours	Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia	24 hours

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: William B Young, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: GON/WBY/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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