NCT06069791 · Yale University
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
What this study is about
The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomly assigned to receive three different concentrations, which will be injected one week apart each.
View original scientific description
The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.
Interventions
DRUG
Bupivacaine Injection
subcutaneous injection around bilateral greater occipital nerves
Primary outcome measures
Acute sensation felt during injection: quality
Time frame: During injection
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Acute sensation felt during injection: intensity
Time frame: During injection
The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale
Paresthesia felt after injection: quality
Time frame: From the time of injection to 1 week after injection
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Paresthesia felt after injection: intensity
Time frame: From the time of injection to 1 week after injection
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Paresthesia felt after injection: distribution
Time frame: From the time of injection to 1 week after injection
The location of the sensation over the scalp after injection, drawn on figure of head and neck
Paresthesia felt after injection: duration
Time frame: From the time of injection to 1 week after injection
The duration of the sensation over the scalp after injection (hours)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine
- Instruction from clinician to avoid amide anesthetics, such as lidocaine
- Pregnant or lack of adequate birth control
Where
- West Haven, Connecticut
Collaborators
VA Connecticut Healthcare System, National Headache Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations