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| ID | Type | Description | Link |
|---|---|---|---|
| Tian Medical Inc. | Other Identifier | Tian Medical Inc |
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The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Bupivicaine .03ml to each nare |
|
| Normal Saline | Placebo Comparator | normal saline .03 ml to each nare |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale | 15 minutes from dose |
| Measure | Description | Time Frame |
|---|---|---|
| Categorical Pain Relief | Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as "No", "Little", "Some", "A Lot" or "Complete". The table displays the number of participants who identified their pain relief in the categories provided. | 15 minutes from dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason T Schaffer, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
93 Patients Enrolled 47 Patients Excluded 25 Patients Declined
165 Patients Identified
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine | Bupivicaine .03ml to each nare Bupivacaine: intervention |
| FG001 | Normal Saline | normal saline .03 ml to each nare Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine | Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally |
| BG001 | Normal Saline | Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale | Posted | Number | percentage of participants | 15 minutes from dose |
|
|
24 Hours
At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.
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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 | Bupivacaine | Bupivicaine .03ml to each nare Bupivacaine: intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Congestion | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Schaffer, MD | Indiana University School of Medicine | 317-962-8026 | jtschaff@iupui.edu |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo |
| Drug |
Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion |
|
|
| Headache Free at 24 Hours |
The percentage of patients that were headache free at 24 hours by follow-up phone conversation. |
| 24 hours |
| Pregnancy |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Median Baseline Headache Score | 0mm (No Pain) to 100mm (Maximum Pain) on 100mm Visual Analog Scale | Median | Inter-Quartile Range | units on a scale |
|
| Median Baseline Nausea Score | 0mm (No Nausea) to 100mm (Maximum Nausea) on 100mm Visual Analog Scale | Median | Inter-Quartile Range | units on a scale |
|
|
|
| Secondary | Categorical Pain Relief | Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as "No", "Little", "Some", "A Lot" or "Complete". The table displays the number of participants who identified their pain relief in the categories provided. | Posted | Number | participants | 15 minutes from dose |
|
|
|
| Secondary | Headache Free at 24 Hours | The percentage of patients that were headache free at 24 hours by follow-up phone conversation. | Posted | Number | percentage of participants | 24 hours |
|
|
|
|
| 0 |
| 41 |
| 5 |
| 41 |
| EG001 | Normal Saline | normal saline .03 ml to each nare Placebo: Placebo | 0 | 46 | 3 | 46 |
| Sore Throat | General disorders | Non-systematic Assessment |
|
| Minor Epistaxis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hoarseness | General disorders | Non-systematic Assessment |
|
| Nasal Dryness | General disorders | Non-systematic Assessment |
|
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| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Some Pain Relief |
|
| A Lot of Pain Relief |
|
| Complete Pain Relief |
|