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.
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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.
VA Connecticut Healthcare System
West Haven, Connecticut, United States
RECRUITINGChange in headache days/week in the first month
Change in the weekly number of headache days after GON blockade
Time frame: From one month before to one month after injection
Change in headache days/week over two months
Change in number of days per week with headache
Time frame: From one month before to two months after injection
Change in average headache pain intensity
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Time frame: From one month before to two months after injection
Change in average attack duration
Hours
Time frame: From one month before to two months after injection
Change in average headache-associated light sensitivity
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Time frame: From one month before to two months after injection
Change in average headache-associated sound sensitivity
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Time frame: From one month before to two months after injection
Change in average headache-associated nausea/vomiting
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Time frame: From one month before to two months after injection
Change in average headache-associated functional impairment
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Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Time frame: From one month before to two months after injection
Change in average days/week using headache abortive treatment
Number of days per week using an abortive treatment for headache
Time frame: From one month before to two months after injection
Patient Global Impression of Change scale (PGIC)
Scale of 1-7 with higher scores indicating worse outcome.
Time frame: From one month before to two months after injection
Migraine-Specific Quality of Life questionnaire (v2.1) (MSQ)
0-to-100 scale. Higher scores indicate better quality of life.
Time frame: From one month before to two months after injection
Migraine Disability Assessment (MIDAS)
Score from 0 to 270. Higher scores indicating more severe disability.
Time frame: From one month before to two months after injection
Number of participants with Adverse events
Number of participants with Adverse events that occur during or after injection
Time frame: From one month before to two months after injection