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The P.I. decided to cancel this study. On 10/08/19, a study closure request was submitted to the IRB.
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The purpose of this study is to compare the outcomes of an Adductor canal block (ACB) + interspace between the popliteal artery and the capsule of the knee (IPACK) block along with a single intraoperative injection of a standard local anesthetic that includes Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline to an ACB + IPACK block without the intraoperative injection of a standard local anesthetic in patients undergoing Robotic Arm-Assisted TKA (RA-TKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - ACB + IPACK with injection | Experimental | 50 arms: ACB + IPACK block with injection of local anesthetic of Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline |
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| B - ACB + IPACK without injection | Active Comparator | 50 arms: ACB + IPACK block without injection of local anesthetic |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACB + IPACK block with injection of local anesthetic | Other | ACB + IPACK block with injection of local anesthetic which is comprised of the following agents and amounts:
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| Measure | Description | Time Frame |
|---|---|---|
| total length of hospital stay | total length of hospital stay as defined by number of days from date of surgery to date of discharge | outcome measure will be taken at 2 weeks postoperatively |
| Knee Society Score | Knee Society Score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. A higher value represents a better outcome. | outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively. |
| WOMAC score | WOMAC score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome. | outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively |
| Visual Analog Scale | The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale. | outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively. |
| Amount of narcotic medication utilized | Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Malkani, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| ACB + IPACK block without injection | Other | ACB + IPACK block without an injection of local anesthetic |
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| outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively |
| Ability to rise from a chair independently | Ability to rise from a chair independently (Yes/No) | outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively |
| Active range-of-motion (ROM) | Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees) | outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively |
| Distance that patient is able to walk | Distance that patient is able to walk, as measured in feet | outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively |
| Use of an ambulatory assistive device | Use of an ambulatory assistive device (Yes/No) | outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively |
| Return to driving | Return to driving (Yes/No) | outcome measure will be taken 2 weeks (± 4 days) postoperatively and 6 weeks (± 2 weeks) postoperatively |