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Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepivacaine 37.5 mg | Active Comparator |
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| Mepivacaine 30 mg plus fentanyl 10 µg | Active Comparator |
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| Mepivacaine 27 mg plus fentanyl 10 µg | Active Comparator |
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| Mepivacaine 24 mg plus fentanyl 10 µg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepivacaine (24 mg) plus fentanyl | Procedure | Mepivacaine (24 mg) and fentanyl (10 µg) |
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| Measure | Description | Time Frame |
|---|---|---|
| Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery | Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepivacaine 37.5 mg | Mepivacaine (37.5 mg) |
| FG001 | Mepivacaine 30 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mepivacaine (27 mg) plus fentanyl | Procedure | Mepivacaine (27 mg) and fentanyl (10 µg) |
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| Mepivacaine (30 mg) plus fentanyl | Procedure | Mepivacaine (30 mg) and fentanyl (10 µg) |
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| Mepivacaine | Procedure | Mepivacaine 37.5 mg |
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| FG002 | Mepivacaine 27 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg) |
| FG003 | Mepivacaine 24 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepivacaine 37.5 mg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) |
| BG001 | Mepivacaine 30 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) |
| BG002 | Mepivacaine 27 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) |
| BG003 | Mepivacaine 24 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/(m^2) |
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| 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 | Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery | Posted | Median | Inter-Quartile Range | minutes | Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours. |
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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 | Mepivacaine 37.5 mg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 0 | 22 | 0 | 22 | ||
| EG001 | Mepivacaine 30 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 0 | 6 | 0 | 6 | ||
| EG002 | Mepivacaine 27 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 0 | 10 | 0 | 10 | ||
| EG003 | Mepivacaine 24 mg Plus Fentanyl 10 µg | Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Cheng | Hospital for Special Surgery | 212-774-7377 | chengj@hss.edu |
| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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