Bupivacaine injections for veterans with post-concussion headaches
Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1
This study is testing different strengths of bupivacaine injections to see if they can help veterans with headaches after a concussion feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT06069791 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different concentrations of bupivacaine in greater occipital nerve blockade for veterans suffering from post-traumatic headaches. Participants will receive three varying concentrations of bupivacaine, administered one week apart, to assess their acute and subacute sensations. The goal is to identify a suitable control dose for future efficacy trials, ultimately aiming to improve headache management in military servicemembers and veterans. This approach seeks to provide a safe and effective alternative to existing headache treatments that may have limitations.
Who should consider this trial
Good fit: Ideal candidates are U.S. military veterans within the VA Connecticut Healthcare System who experience chronic post-traumatic headaches.
Not a fit: Patients with skull defects or contraindications to bupivacaine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer veterans a new, effective method for managing chronic post-traumatic headaches.
How similar studies have performed: Other studies have shown promise with similar nerve blockade techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * United States Military Veterans within VA Connecticut Healthcare System * Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury) * At least two headache days per week * MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years, and within 5 years if chronic PTH for more than 10 years * Review of MRI and the medical record does not reveal another source for headache Exclusion Criteria: * Skull defect * Other contraindication to bupivacaine 1. Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine 2. Instruction from clinician to avoid amide anesthetics, such as lidocaine * Pregnant or lack of adequate birth control
Where this trial is running
West Haven, Connecticut
- VA Connecticut Healthcare System — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Emmanuelle Schindler, MD, PhD
- Email: emmanuelle.schindler@va.gov
- Phone: 203-932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.