Opioid-Free Accelerated Recovery Total Knee Arthroplasty
Conditions: Arthropathy of Knee Joint
Sponsor: St. Elizabeth Medical Center, Utica, NY

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
qIIS Protocol: Opioid-free Accelerated Recovery Total Knee Arthroplasty 
Andrew Wickline, M.D. 
 
NCT03647709 
 
April 30,2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objectives:  
● To prove that total knee arthroplasty can be performed with little, if any need for opioids 
using a combination of education, optimized pre-op and post-op pain protocols, and 
optimized recovery protocols.   
● The secondary objective is to show that nearly all patients can be treated as outpatient 
joint replacements  
 
Study Group:  
All total knee arthroplasties  
Comparison Group:  
Cohort study: Start with 2- 3 months of patient enrollments (approximately 40 TKR/month). This 
could be baseline. In a years’ time that would equal approximately 500 patients. We then collect 
data for 1 year. We can further examine other various outcome variables. The goal being opioid 
free total knee arthroplasty. To our knowledge there have been few studies using a multimodal 
approach that indicates the approximate number of opioid tablets physicians should order post- 
total knee replacement surgery that deals with patient’s surgical pain. This is in part due to the 
unknown actual number of tablets taken post-op for surgical pain versus other comorbidities in 
these patients. Most studies are based on actual refills of opioids following total knee 
replacements. There has been other studies to examine post-operative opioid trends, predictors 
and use following total joint arthroplasty:  
Dwyer, Maureen K, Trumpowsky, Catherine M, Hiltz,Nancy L, Lee, Joann, Healy, William 
L, Bedair, Hany S. et al. Characterization of Post-Operative Opioid Use Following Total 
Joint Arthroplasty  
Goesling J. Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, et al. Trends and 
Predictors of Opioid Use After Total Knee and Hip Arthroplasty  
 
Design: 
Prospective, consecutive case series with historical matched control group 
• 
All study patients will receive a standardized protocol  
● All surgical procedures performed by a single surgeon using the same implants, same 
approach, same pre-op and post-op optimization, and same simplified pain protocol at a 
single hospital center and surgery center  
          ● Researchers will attempt to minimize the number of anesthesiologists to further      
control variability in care 
  
Research Team:  

● Andrew Wickline, M.D., Principal Investigator, Surgeon – will review data weekly to 
ensure quality data collection  
● PA’s -Dennis Golis, Chuck Stefan, Anne Moore  
● Full-time research associate Rph Mary Ann Stevenson – responsible for data collection  
Methods 
1. Data Collection  
● EMR chart review (historical control)  
● Pre-op assessment  
● Post-op assessment – PACU, Phase II (prior to discharge)  
● Phone calls after discharge  
● Follow-up assessment in surgeon’s office  
● SwiftPath®  
● KOOS, JR  
2. Pre-op Optimization  
● All patients enroll in SwiftPath® education program  
● All patients have optimized BMI, hemoglobin, albumin, glucose control – A1C, and blood 
pressure control  
3. Total Joint Procedure:  
● Tourniquet-free cemented TKA performed with intra-articular block  
4. Pain Management Regimen for TKA:  
● Pre-op patient education regimen, which includes pre-op physical therapy 
teaching  
● Post-op multimodal pain management regimen: Oxycodone 5mg every 4 to 6 
hours or Tramadol 50mg every 4-6 hours, Acetaminophen 1000 mg three times a 
day, Celebrex 100mg twice a day, or Mobic 7.5mg twice a day, and cryotherapy 
(ice therapy)  
● All patients have u/s guided adductor canal block with catheter  
● Patients receive ON-Q adjustable pain ball in the recovery room starting at 4 ml/hr and 
are discharged when criteria the following criteria is met: ability to ambulate, can tolerate 
food/fluids, controlled nausea/vomiting, ability to empty bladder, vital signs within pre-op 
values, ability to pass physical therapy assessment for daily living skills  
● Anesthesiologist regimen: adductor canal block with 20 ml ropivicaine 0.2% followed by 
catheter placement, a continuous infusion via pain ball containing ropivicaine 0.2% at 
starting rate of 4ml/hour in post- acute care unit (PACU). Patient given instructions on how 
to self- adjust infusion rate before discharge. Patient has the ability to titrate dose after 
discharge with duration lasting 3 to 5 days.  
 

5. Inclusion Criteria:  
● Partial and total knee arthroplasty  
● Unilateral only  
● Patient surgeries scheduled to be performed at the hospital and surgery center  
● Patients must enroll in SwiftPath®  
● Ability to read and understand English  
● Primary care clearance for patients diagnosed with high/low blood pressures  
6. Exclusion Criteria:  
● Disease states, patient conditions to exclude-schizophrenia, bipolar disease, dementia  
● Known allergies to local anesthetics  
● Contraindications for regional analgesia  
● Previous burn to affected extremity  
● Previous fracture to affected extremity  
● BMI >40  
● Hemoglobin <12 female, <13 male  
● Albumin less than 3.5  
● A1C >8.0  
Outcomes  
1. Primary Outcomes:  
● Post-op opioid consumption   
● Pre-op opioid consumption 
● Peri-op opioid consumption 
 
 2. Secondary Outcomes:  
● Pain scores-NRS  
● Sleep quality  
● Adherence to prescribed post-op recovery protocol  
● ROM  
● Adverse events  
● Serious side effects   
● Length of stay in hospital (surgery to discharge)   
● KOOS, JR and Swiftpath  
  
● Discharge disposition  
● Number of Physical Therapy visits – in-home vs outpatient 
 

3. Data collection   
●Intervals: PACU, DOS, POD 1, 2, 3, 10-14, 3week, 6week, 12weeks   
● SwiftPath; A program that emphasizes patient/family engagement and 
education, using MIS techniques, reduction in narcotic use, utilization of 
modern pain management and early mobilization   
● KOOS JR:This is a survey that is an assessment and questionnaire that 
rates a patient joint pain, stiffness and function in daily living.