Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To assess postoperative patient-reported quality of recovery after total knee arthroplasty (TKA) with periarticular joint injection (PAI) ± single shot adductor canal block with or without adductor canal catheter infusion.

Detailed Description
-----------------
Knee osteoarthritis (KOA) is a leading cause of chronic knee pain and disability, with a lifetime prevalence of 45%. Treatment for symptomatic KOA includes physical therapy, oral anti-inflammatory medications and intra-articular steroid injections, with total knee arthroplasty (TKA) (or knee replacement) as the definitive treatment. Acute postoperative pain is common after TKA, leading to increased opioid consumption and increased hospital length of stay. Pain control following TKA has been investigated with interventions such as intrathecal morphine, nerve blocks, and periarticular joint injection (PAI). PAI and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing TKA. The aim of this study is to assess postoperative patient-reported quality of recovery after TKA with PAI and single shot adductor canal block with or without adductor canal catheter infusion.

Official Title
-----------------
Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty: Quality Of Recovery Through Patient Reporting - a Multisite Study

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients presenting for a primary TKA. Exclusion Criteria: Age <18 years; Body mass index ≥45 kg/m2; Weight <80 kg; Deemed unsuitable for regional anesthesia; Planned general anesthesia; Hepatic insufficiency/Intolerance to acetaminophen; Renal insufficiency (defined by estimated glomerular filtration rate <60 mL/min/1.73 m2); Chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine per hour for greater than 1 month); Allergy or intolerance to study medications (listed under 'Spinal and Adductor Canal Block') or trial medications listed in Postoperative section and standard prescription Clinical Frailty Scale score ≥4;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cACB active<br>Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication) | Drug: Ropivacaine<br>* 800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)<br>|
| Placebo Comparator: cACB sham<br>Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline) | Drug: Normal saline<br>* 400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-15 Survey scores | Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery | Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-15 Survey scores | Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery | Postoperative days 10 and 42 | 
| Brief Pain Inventory - Pain Interference scores | On a scale of 0-10, where 0=Does not interfere and 10=Completely interferes, Patients will rate how much their pain interferes with: General activity, Mood, Walking ability, Normal work including housework, Relations with other people, Sleep, and Enjoyment of life | Postoperative days 1, 2 and 3 in the morning | 
| Pain Numerical Rating Scale at rest | Patient-reported pain measured on an 11-point scale from 0 [no pain] to 10 [worst pain imaginable] | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 | 
| Pain Numerical Rating Scale with activity | Patient-reported pain measured on an 11-point scale from 0 [no pain] to 10 [worst pain imaginable] | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy | 
| Functional Recovery: Range of motion | Flexion and Extension range of motion measured in degrees | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy | 
| Functional Recovery: Time to reach discharge criteria | Physiotherapist to assess when patient meets discharge criteria (measured in half days) | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy | 
| Functional Recovery: Timed Up and Go test | Time it takes for patient to stand up from sitting in a chair, walk 3 meters, then turn and walk back to chair and sit down, measured in seconds | Postoperative day 42 | 
| Frequency of opioid-related side effects (vomiting and nausea) | Number of vomiting events or complaints of nausea noted in nursing notes | Up to 3 days | 
| Narcotic consumption in hospital | total amount and route of administration collected from routine and PRN opioid use in PACU and on surgical floor - measured in mg of oral morphine equivalence | Up to 3 days | 
| Narcotic consumption at home | Post-discharge opioid consumption will be tracked with pill count on POD 1 or 2, 3 POD10 (± 2 days), and POD42 (± 2 days); on POD 42 - patient to show study nurse how many pills remain to ensure reporting accuracy | Postoperative day 42 | 
| Complications | i. return to hospital once discharged for non-analgesic reasons ii. require more pain medications outside of prescription given | Postoperative days 10 and 42 |