Back to resultsPain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA
Primary Purpose
Knee Arthropathy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
preop ACB, followed by Intra-articular block during TKA surgery
preop ACB+IPACK block
preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
Sponsored by
About this trial
This is an interventional basic science trial for Knee Arthropathy
Eligibility Criteria
Inclusion Criteria:
- Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
- Patient age is 22-89 at time of TKA surgery.
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
- Patient is able to read and speak English.
Exclusion Criteria:
- Patient is under the age of 22 or over the age of 89.
- 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 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A - ACB + Periarticular Block
B - ACB + IPACK Block
C - ACB + IPACK + Periarticular Block
Arm Description
Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery
Group B: patient will receive a preop ACB+IPACK block before TKA surgery only
Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
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)
Incidence of postop complications
Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.
Secondary Outcome Measures
Full Information
NCT ID
NCT04292392
First Posted
February 28, 2020
Last Updated
November 2, 2020
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT04292392
Brief Title
Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA
Official Title
Comparison of Pain Levels and Opioid Usage in ACB + Periarticular Block vs. ACB + IPACK Block vs. ACB + IPACK + Periarticular Block in Patients Undergoing Primary TKA
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Final protocol and ICF has not been approved by local IRB. No subjects have been enrolled. Study will not be pursued due to current COVID-19 pandemic.
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
September 30, 2020 (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 primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.
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 + Periarticular Block
Arm Type
Experimental
Arm Description
Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery
Arm Title
B - ACB + IPACK Block
Arm Type
Experimental
Arm Description
Group B: patient will receive a preop ACB+IPACK block before TKA surgery only
Arm Title
C - ACB + IPACK + Periarticular Block
Arm Type
Experimental
Arm Description
Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
Intervention Type
Other
Intervention Name(s)
preop ACB, followed by Intra-articular block during TKA surgery
Intervention Description
Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, 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)
preop ACB+IPACK block
Intervention Description
Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block
Intervention Type
Other
Intervention Name(s)
preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
Intervention Description
Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, 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
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
Incidence of postop complications
Description
Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
Patient age is 22-89 at time of TKA surgery.
Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
Patient is able to read and speak English.
Exclusion Criteria:
Patient is under the age of 22 or over the age of 89.
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 L 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
Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA
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