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

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1

Conditions
-----------------
Post-Traumatic Headache

Intervention / Treatment
-----------------
* Drug: Bupivacaine Injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: incomplete block assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each | Drug: Bupivacaine Injection<br>* subcutaneous injection around bilateral greater occipital nerves<br>|
| Experimental: Group 2<br>bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each | Drug: Bupivacaine Injection<br>* subcutaneous injection around bilateral greater occipital nerves<br>|
| Experimental: Group 3<br>bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each | Drug: Bupivacaine Injection<br>* subcutaneous injection around bilateral greater occipital nerves<br>|
| Experimental: Group 4<br>bupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each | Drug: Bupivacaine Injection<br>* subcutaneous injection around bilateral greater occipital nerves<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute sensation felt during injection: quality | The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching) | During injection | 
| Acute sensation felt during injection: intensity | The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale | During injection | 
| Paresthesia felt after injection: quality | The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness) | From the time of injection to 1 week after injection | 
| Paresthesia felt after injection: intensity | The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale | From the time of injection to 1 week after injection | 
| Paresthesia felt after injection: distribution | The location of the sensation over the scalp after injection, drawn on figure of head and neck | From the time of injection to 1 week after injection | 
| Paresthesia felt after injection: duration | The duration of the sensation over the scalp after injection (hours) | From the time of injection to 1 week after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Complications that occur during or after injection | From the first injection to two weeks after the last injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury, veteran, VA Connecticut Healthcare System