VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Location status: Recruiting
NCT Number: NCT06069791
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
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.
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subcutaneous injection around bilateral greater occipital nerves
Time frame: During injection
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Time frame: During injection
The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale
Time frame: From the time of injection to 1 week after injection
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Time frame: From the time of injection to 1 week after injection
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Time frame: From the time of injection to 1 week after injection
The location of the sensation over the scalp after injection, drawn on figure of head and neck
Time frame: From the time of injection to 1 week after injection
The duration of the sensation over the scalp after injection (hours)
Time frame: From the first injection to two weeks after the last 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 1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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