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Steroid Occipital Nerve Block for Headache
Phase 4
Recruiting
Led By Carrie Robertson, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 4 weeks
Awards & highlights
Study Summary
This trial will look at if adding a steroid to occipital nerve block improves headaches.
Who is the study for?
This trial is for individuals who can consent, have been stable on headache prevention meds for at least a month, and suffer from headaches like occipital neuralgia or migraines. It's not for pregnant people, those with allergies to the drugs used, infections at the injection site, certain head or neck issues, or recent nerve blocks.Check my eligibility
What is being tested?
The study tests if adding dexamethasone (a steroid) to an occipital nerve block helps more than just using local anesthetics (bupivacaine and lidocaine) with saline in treating headaches. Participants will receive these treatments directly around the nerves that might cause their pain.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site such as pain or infection, allergic reactions to any of the medications used (bupivacaine, lidocaine, dexamethasone), and potential short-term increases in blood sugar levels due to steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 2 weeks, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Headache days 1 week following treatment
Headache days 2 weeks following treatment
Headache days 4 weeks following treatment
Secondary outcome measures
Acute medication use
Headache Severity
Location of headache
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Anesthetic with dexamethasone groupExperimental Treatment4 Interventions
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Group II: Anesthetic without steroid groupActive Control4 Interventions
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Lidocaine
2011
Completed Phase 4
~1360
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,215 Previous Clinical Trials
3,767,123 Total Patients Enrolled
17 Trials studying Headache
952 Patients Enrolled for Headache
Carrie Robertson, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Headache
10 Patients Enrolled for Headache
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to bupivacaine, lidocaine, or dexamethasone in the past.You have an infection or bleeding where the injection will be given.You have had surgeries near the neck or head that would make it difficult to use a specific injection technique.You have been treated for different types of headaches, like migraine or neck-related headaches.You have been diagnosed with cluster headache as per the International Classification of Headache Disorders 3rd edition.You have had a nerve block in your head or neck in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Anesthetic without steroid group
- Group 2: Anesthetic with dexamethasone group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is the Anesthetic with dexamethasone group considered risk-free?
"Data from Phase 4 trials has demonstrated the safety of Anesthetic with dexamethasone group, resulting in our team at Power awarding it a score of 3."
Answered by AI
Are new participants still being accepted for this clinical experiment?
"According to the clinicaltrials.gov portal, this trial is actively seeking participants as of February 16th 2023; its initial posting was on February 1st of that same year."
Answered by AI
How many individuals have volunteered to participate in this trial?
"Correct. Clinicaltrials.gov details that this study, which was originally advertised on February 1st 2023, is still open for recruitment. The clinical trial needs to recruit 120 participants from one medical facility."
Answered by AI
What outcomes is this medical research attempting to achieve?
"This research study, with a period of observation lasting 7 days, is aiming to assess the number of headache days in participants two weeks after treatment. Other metrics evaluated include the amount of acute medication used following treatment and self-reported location of headaches."
Answered by AI
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