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

NCT03840122 | Withdrawn

• 1 other identifier: 18.1246
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Arthropathy

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

A - ACB + IPACK with injection

EXPERIMENTAL

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

B - ACB + IPACK without injection

ACTIVE COMPARATOR

50 arms: ACB + IPACK block without injection of local anesthetic

Other: ACB + IPACK block without injection

Interventions

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: * Ropivacaine 5mg/ml (49.25ml) * Epinephrine 1mg/ml (0.5ml) * Ketorolac 30mg/ml (1ml) * Clonidine 0.1mg/ml (0.8ml) * Saline 48.45ml

A - ACB + IPACK with injection

ACB + IPACK block without injection OTHER

ACB + IPACK block without an injection of local anesthetic

B - ACB + IPACK without injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Arthur Malkani, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Adult Reconstruction

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 15, 2019
• Study Start: October 8, 2019
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)