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

Overview

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).

Full Title of Study: “Comparing ACB + IPACK Block With or Without Local Infiltration in Patients Undergoing Primary Robotic Arm-Assisted TKA”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 8, 2019

Interventions

  • Other: ACB + IPACK block with injection of local anesthetic
    • 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
  • Other: ACB + IPACK block without injection
    • ACB + IPACK block without an injection of local anesthetic

Arms, Groups and Cohorts

  • Experimental: A – ACB + IPACK with injection
    • 50 arms: ACB + IPACK block with injection of local anesthetic of Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline
  • Active Comparator: B – ACB + IPACK without injection
    • 50 arms: ACB + IPACK block without injection of local anesthetic

Clinical Trial Outcome Measures

Primary Measures

  • total length of hospital stay
    • Time Frame: outcome measure will be taken at 2 weeks postoperatively
    • total length of hospital stay as defined by number of days from date of surgery to date of discharge
  • Knee Society Score
    • Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.
    • 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.
  • WOMAC score
    • Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively
    • 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.
  • Visual Analog Scale
    • Time Frame: 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.
    • 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.
  • Amount of narcotic medication utilized
    • Time Frame: 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 (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
  • Ability to rise from a chair independently
    • Time Frame: 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 (Yes/No)
  • Active range-of-motion (ROM)
    • Time Frame: 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 ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
  • Distance that patient is able to walk
    • Time Frame: 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, as measured in feet
  • Use of an ambulatory assistive device
    • Time Frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively
    • Use of an ambulatory assistive device (Yes/No)
  • Return to driving
    • Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively and 6 weeks (± 2 weeks) postoperatively
    • Return to driving (Yes/No)

Participating in This Clinical Trial

Inclusion Criteria

1. Patient is over the age of 21 2. Patient is scheduled to undergo a unilateral, primary TKA, secondary to osteoarthritis 3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents 4. Patient is able to read and speak English. Exclusion Criteria:

1. Patient is under the age of 21 2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis) 3. Patient is scheduled to undergo a bilateral TKA surgery 4. Patient is unable to read and speak English

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Louisville
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arthur Malkani, Professor, Adult Reconstruction – University of Louisville
  • Overall Official(s)
    • Arthur Malkani, MD, Principal Investigator, University of Louisville

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