Back to resultsACB + IPACK Block With or Without Local Infiltration in RA-TKA
Primary Purpose
Knee Arthropathy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACB + IPACK block with injection of local anesthetic
ACB + IPACK block without injection
Sponsored by
About this trial
This is an interventional basic science trial for Knee Arthropathy
Eligibility Criteria
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
Sites / Locations
- Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A - ACB + IPACK with injection
B - ACB + IPACK without injection
Arm Description
50 arms: ACB + IPACK block with injection of local anesthetic of Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline
50 arms: ACB + IPACK block without injection of local anesthetic
Outcomes
Primary Outcome Measures
total length of hospital stay
total length of hospital stay as defined by number of days from date of surgery to date of discharge
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.
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.
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.
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Return to driving
Return to driving (Yes/No)
Secondary Outcome Measures
Full Information
NCT ID
NCT03840122
First Posted
January 30, 2019
Last Updated
October 8, 2019
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03840122
Brief Title
ACB + IPACK Block With or Without Local Infiltration in RA-TKA
Official Title
Comparing ACB + IPACK Block With or Without Local Infiltration in Patients Undergoing Primary Robotic Arm-Assisted TKA
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
The P.I. decided to cancel this study. On 10/08/19, a study closure request was submitted to the IRB.
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - ACB + IPACK with injection
Arm Type
Experimental
Arm Description
50 arms: ACB + IPACK block with injection of local anesthetic of Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline
Arm Title
B - ACB + IPACK without injection
Arm Type
Active Comparator
Arm Description
50 arms: ACB + IPACK block without injection of local anesthetic
Intervention Type
Other
Intervention Name(s)
ACB + IPACK block with injection of local anesthetic
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
ACB + IPACK block without injection
Intervention Description
ACB + IPACK block without an injection of local anesthetic
Primary Outcome Measure Information:
Title
total length of hospital stay
Description
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
Title
Knee Society Score
Description
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.
Title
WOMAC score
Description
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
Title
Visual Analog Scale
Description
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.
Title
Amount of narcotic medication utilized
Description
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
Title
Ability to rise from a chair independently
Description
Ability to rise from a chair independently (Yes/No)
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
Title
Active range-of-motion (ROM)
Description
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
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
Title
Distance that patient is able to walk
Description
Distance that patient is able to walk, as measured in feet
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
Title
Use of an ambulatory assistive device
Description
Use of an ambulatory assistive device (Yes/No)
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
Title
Return to driving
Description
Return to driving (Yes/No)
Time Frame
outcome measure will be taken 2 weeks (± 4 days) postoperatively and 6 weeks (± 2 weeks) postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Malkani, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ACB + IPACK Block With or Without Local Infiltration in RA-TKA
We'll reach out to this number within 24 hrs