Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine Injection.
- Who it may be relevant to
- Registry conditions: Post-Traumatic Headache. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1
Overview
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.
Detailed description
Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted.
Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden.
The acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic GON blockade make controlled investigations against placebo difficult to interpret. In sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. Acute and subacute sensations from bupivacaine GON blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2).
Interventions
- Drug Bupivacaine Injection
subcutaneous injection around bilateral greater occipital nerves
Primary outcome measures
- Acute sensation felt during injection: quality [Time frame: During injection]
- Acute sensation felt during injection: intensity [Time frame: During injection]
- Paresthesia felt after injection: quality [Time frame: From the time of injection to 1 week after injection]
- Paresthesia felt after injection: intensity [Time frame: From the time of injection to 1 week after injection]
- Paresthesia felt after injection: distribution [Time frame: From the time of injection to 1 week after injection]
- Paresthesia felt after injection: duration [Time frame: From the time of injection to 1 week after injection]
Secondary outcome measures (1)
- Adverse events [Time frame: From the first injection to two weeks after the last injection]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- VA Connecticut Healthcare System — West Haven
Identifiers
NCT: NCT06069791 · 1656679