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| ID | Type | Description | Link |
|---|---|---|---|
| STU00083918 | Other Identifier | Institutional Review Board (IRB) |
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Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine.
Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | 4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine |
|
| Triamcinolone | Active Comparator | 40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 4 mL of 0.25% bupivacaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | The number of subjects reporting a minimum of 50% pain relief after receiving the injection. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoun Nader, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesiology Pain Medcine Center | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 2 | 4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine Bupivacaine: 4 mL of 0.25% bupivacaine Dexamethasone: 4 mg of Dexamethasone |
| FG001 | Group 1 | 40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine Bupivacaine: 4 mL of 0.25% bupivacaine Triamcinolone: 40 mg of Triamcinolone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 2 | 4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine Bupivacaine: 4 mL of 0.25% bupivacaine Dexamethasone: 4 mg of Dexamethasone |
| BG001 | Group 1 | 40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine Bupivacaine: 4 mL of 0.25% bupivacaine Triamcinolone: 40 mg of Triamcinolone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | The number of subjects reporting a minimum of 50% pain relief after receiving the injection. | Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection. | Posted | Count of Participants | Participants | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | 4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine Bupivacaine: 4 mL of 0.25% bupivacaine Dexamethasone: 4 mg of Dexamethasone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient numbing of the facial nerve | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antoun Nader, M.D. | Northwestern University, Feinberg School of Medicine | 312-695-4814 | a-nader2@northwestern.edu |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014221 | Triamcinolone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Triamcinolone |
| Drug |
40 mg of Triamcinolone |
|
| Dexamethasone | Drug | 4 mg of Dexamethasone |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Group 2 | 40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine Bupivacaine: 4 mL of 0.25% bupivacaine Triamcinolone: 40 mg of Triamcinolone | 0 | 30 | 0 | 30 | 1 | 30 |
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| D000588 |
| Amines |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011246 | Pregnadienetriols |