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The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy.
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy. Randomized, double-blinded, placebo controlled, study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Sham Comparator | A sham infrapatellar block performed under US guidance with normal saline |
|
| Infrapatellar nerve block | Experimental | An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25% Bupivacaine | Drug | 10cc, single dose, US guided injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post op Pain Score | immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain. | 0 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Nuber, MD | Northwestern University | Principal Investigator |
| Antoun Nader, MD | Northwestern University | Study Director |
| Lawrence Hsu, MD | Northwestern University | Study Director |
| Mark Kendall, MD | Northwestern University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olson Surgical Pavilion | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18574578 | Background | Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24. | |
| 17005509 | Background | Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A sham infrapatellar block performed under US guidance with normal saline Normal Saline: 10cc, single dose, US guided injection |
| FG001 | Infrapatellar Nerve Block | An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine 0.25% Bupivacaine: 10cc, single dose, US guided injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Both groups statistically similar
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A sham infrapatellar block performed under US guidance with normal saline Normal Saline: 10cc, single dose, US guided injection |
| BG001 | Infrapatellar Nerve Block | An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine 0.25% Bupivacaine: 10cc, single dose, US guided injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post op Pain Score | immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain. | Posted | Mean | Standard Deviation | units on a scale | 0 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 | Placebo | A sham infrapatellar block performed under US guidance with normal saline Normal Saline: 10cc, single dose, US guided injection |
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outpatient nature and self reporting of outcome measures
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Hsu, MD | Northwestern | 312 9262000 | larryphsu@gmail.com |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009407 | Nerve Block |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Drug | 10cc, single dose, US guided injection |
|
|
| 3344881 | Background | Arthornthurasook A, Gaew-Im K. Study of the infrapatellar nerve. Am J Sports Med. 1988 Jan-Feb;16(1):57-9. doi: 10.1177/036354658801600110. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Infrapatellar Nerve Block | An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine 0.25% Bupivacaine: 10cc, single dose, US guided injection | 0 | 34 | 0 | 34 |
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| D000588 |
| Amines |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |