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Local Anesthetic

Bupivacaine Injection for Post-Traumatic Headache

Phase 1
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Review of MRI and the medical record does not reveal another source for headache
Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury)
Must not have
Instruction from clinician to avoid amide anesthetics, such as lidocaine
Other contraindication to bupivacaine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of injection to 1 week after injection
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how different concentrations of a drug affect pain relief in the scalp. Each participant is randomly given 3 different doses over 3 weeks.

Who is the study for?
This trial is for U.S. Military Veterans within the VA Connecticut Healthcare System who suffer from chronic post-traumatic headaches, occurring at least twice a week. Participants must have had an MRI brain scan recently and their medical records should not indicate another source for their headaches. Pregnant individuals or those with certain allergies, heart conditions related to amide anesthetics, or skull defects cannot participate.
What is being tested?
The study tests how different concentrations of Bupivacaine affect scalp sensations when used in greater occipital nerve blockade in veterans with post-concussion headache. Each participant will receive three varying concentrations of Bupivacaine injections over three separate weeks through random assignment.
What are the potential side effects?
Possible side effects from Bupivacaine injections may include discomfort at the injection site, numbness around the area injected, allergic reactions like rashes, and in rare cases cardiac effects due to sensitivity to amide anesthetics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My MRI shows my headache isn't caused by another health issue.
Select...
I have had headaches for over three months after a head injury.
Select...
I experience headaches at least twice a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My doctor has advised me to avoid certain numbing medications.
Select...
I cannot take bupivacaine due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of injection to 1 week after injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of injection to 1 week after injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute sensation felt during injection: intensity
Acute sensation felt during injection: quality
Paresthesia felt after injection: distribution
+3 more
Secondary study objectives
Adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
bupivacaine \[0.01% or 0.05%\], \[0.05% or 0.1%\], and 0.05% in random order, one week apart each
Group II: Group 3Experimental Treatment1 Intervention
bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each
Group III: Group 2Experimental Treatment1 Intervention
bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each
Group IV: Group 1Experimental Treatment1 Intervention
bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Injection
2017
Completed Phase 4
~690

Find a Location

Who is running the clinical trial?

National Headache FoundationUNKNOWN
2 Previous Clinical Trials
31 Total Patients Enrolled
VA Connecticut Healthcare SystemFED
85 Previous Clinical Trials
8,788 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
20 Patients Enrolled for Post-Traumatic Headache
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,432 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
12 Patients Enrolled for Post-Traumatic Headache
~3 spots leftby Mar 2025
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