ACB + IPACK Block With or Without Local Infiltration in RA-TKA

Study Overview
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Brief Summary
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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).

Official Title
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Comparing ACB + IPACK Block With or Without Local Infiltration in Patients Undergoing Primary Robotic Arm-Assisted TKA

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Other: ACB + IPACK block with injection of local anesthetic
* Other: ACB + IPACK block without injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is over the age of 21 Patient is scheduled to undergo a unilateral, primary TKA, secondary to osteoarthritis Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents Patient is able to read and speak English. Exclusion Criteria: Patient is under the age of 21 Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis) Patient is scheduled to undergo a bilateral TKA surgery Patient is unable to read and speak English

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - ACB + IPACK with injection<br>50 arms: ACB + IPACK block with injection of local anesthetic of Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline | Other: ACB + IPACK block with injection of local anesthetic<br>* ACB + IPACK block with injection of local anesthetic which is comprised of the following agents and amounts: Ropivacaine 5mg/ml (49.25ml) Epinephrine 1mg/ml (0.5ml) Ketorolac 30mg/ml (1ml) Clonidine 0.1mg/ml (0.8ml) Saline 48.45ml<br>|
| Active Comparator: B - ACB + IPACK without injection<br>50 arms: ACB + IPACK block without injection of local anesthetic | Other: ACB + IPACK block without injection<br>* ACB + IPACK block without an injection of local anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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 |