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

University of Louisville

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Conditions

Knee Arthropathy

Interventions

ACB + IPACK block with injection of local anestheticOTHER

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

ACB + IPACK block without injectionOTHER

ACB + IPACK block without an injection of local anesthetic

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Jewish Hospital

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

total length of hospital stay

total length of hospital stay as defined by number of days from date of surgery to date of discharge

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).

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

Data from ClinicalTrials.gov

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