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| Name | Class |
|---|---|
| VA Connecticut Healthcare System | FED |
| National Headache Foundation | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each |
|
| Group 2 | Experimental | bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each |
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| Group 3 | Experimental | bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each |
|
| Group 4 | Experimental | bupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Injection | Drug | subcutaneous injection around bilateral greater occipital nerves |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Complications that occur during or after injection | From the first injection to two weeks after the last injection |
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Inclusion Criteria:
Exclusion Criteria:
Skull defect
Other contraindication to bupivacaine
Pregnant or lack of adequate birth control
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuelle Schindler, MD, PhD | Contact | 203-932-5711 | 4335 | emmanuelle.schindler@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | Recruiting | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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incomplete block assignment
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Both bupivacaine concentration and order of administration will be unknown except to Research Pharmacy
| D009422 | Nervous System Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000588 |
| Amines |