VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Location status: Recruiting
NCT Number: NCT07796074
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
West Haven, Connecticut, 06516, United States
Location status: Recruiting
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%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.
Time frame: From one month before to one month after injection
Change in the weekly number of headache days after GON blockade
Time frame: From one month before to two months after injection
Change in number of days per week with headache
Time frame: From one month before to two months after injection
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
Hours
Time frame: From one month before to two months after injection
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
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
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
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
Number of days per week using an abortive treatment for headache
Time frame: From one month before to two months after injection
PGIC score
Time frame: From one month before to two months after injection
MSQ score
Time frame: From one month before to two months after injection
MIDAS score
Time frame: From one month before to two months after injection
Complications that occur during or after injection
Contact information is provided by the study sponsor or research team.
Yale University
Other
Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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