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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of injection to 1 week after injection

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I have had headaches for over three months after a head injury.

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I experience headaches at least twice a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of injection to 1 week after injection

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute sensation felt during injection: intensity

Acute sensation felt during injection: quality

Paresthesia felt after injection: distribution

+3 more

Secondary outcome measures

Adverse events

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

~580

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Headache FoundationUNKNOWN

2 Previous Clinical Trials

31 Total Patients Enrolled

VA Connecticut Healthcare SystemFED

81 Previous Clinical Trials

6,653 Total Patients Enrolled

1 Trials studying Post-Traumatic Headache

20 Patients Enrolled for Post-Traumatic Headache

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,549 Total Patients Enrolled

1 Trials studying Post-Traumatic Headache

12 Patients Enrolled for Post-Traumatic Headache

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential perils are associated with exposure to Group 1?

"Due to the limited amount of clinical data available, Group 1 was assigned a safety rating of 1 on our scale. This reflects the fact that it is currently undergoing Phase 1 trials and therefore lacks established efficacy and safety profiles."

Answered by AI

How many participants are included in this scientific investigation?

"Yes, the information available on clinicaltrials.gov affirms that this medical study is currently enrolling participants. It was first published on October 2nd 2023 and has been recently amended on September 28th 2023. The researchers are searching for 12 subjects from 1 location."

Answered by AI

Is this research study currently seeking participants?

"Indeed, clinicaltrials.gov confirms that this trial is actively enrolling participants. It was initially posted on October 2nd 2023 and has been revised up to September 28th of the same year. The study requires 12 volunteers at a single site for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1

2024. "Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06069791.

All > Concussion > Traumatic Brain Injury