Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2
Purpose
Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.
Condition
- Post-Traumatic Headache
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- United States Military Veterans within VA Connecticut Healthcare System1. - Head injury with headaches that have continued to occur for at least three months after the head injury - At least two headache days per week - Review of 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 - Clinical review of the patient's case reveals red flag signs or symptoms (e.g., side-locked pain, unilateral numbness/weakness during headache, rapid ascension to peak pain, syncope during attacks) that warrant further work-up (e.g., MRI, arterial imaging). - Absence of imaging warranted by the standard of clinical care for the head injury with headaches.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
0.0% bupivacaine (normal saline) |
|
|
Active Comparator Low dose bupivacaine |
0.05% bupivacaine |
|
|
Experimental Full dose bupivacaine |
0.5% bupivacaine |
|
Recruiting Locations
West Haven, Connecticut 06516
More Details
- Status
- Recruiting
- Sponsor
- Yale University
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. In this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.