Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.

Official Title
-----------------
Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?

Conditions
-----------------
Arthroplasty, Replacement, Knee, Nerve Block, Anesthesia, Regional, Ambulatory Surgical Procedures

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient characteristics suitable for subvastus approach as determined by single surgeon patients willing to undergo ambulatory surgery ability to read and verbally communicate via either English or French Exclusion Criteria: age > 80 driving distance greater than 1 hour from hospital no willing caregiver at home on night of surgery renal failure requiring dialysis Insulin-dependent diabetes mellitus BMI > 45 allergy to study medications pre-existing neurologic deficit involving the ipsilateral limb chronic high dose opioid use (defined as >200mg/day of morphine equivalent for over 2 weeks). inability to use or manage cACB catheter and pump independently at home inability or refusal to cryocompressive therapy device.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline infusion<br>Participants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours | Drug: Normal Saline<br>* This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect<br>|
| Active Comparator: Ropivacaine infusion<br>Participants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours | Drug: Ropivacaine<br>* This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery Scale 15 (QoR-15) | QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery. | at 4pm on post-operative day (POD) 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery Scale 15 (QoR-15) |  | POD 2-4 + 7 | 
| Pain score at rest | Patients will rate their pain on a scale of 0-10 | POD 1-4 + 7 | 
| Pain score with activity | Patients will rate their pain on a scale of 0-10 | POD 1-4 + 7 | 
| Tapentadol consumption | Daily tapentadol use in milligrams | POD 1-4 + 7 | 
| Patient satisfaction | Patients will be asked are you satisfied with your pain control | POD 1-4 + 7 | 
| Vital signs - blood pressure, heart rate, oxygen saturation | These measurements will be obtained via post-operative home monitoring system | twice daily POD 1-4 | 
| Patient-rated catheter effectiveness | Patients will be asked do you think the nerve block catheter is helpful? Rate on a 5-point scale | POD 1-4 | 
| Catheter specific complications | Patients will be asked daily to report these potential nerve block catheter related issues: (1) leakage around the dressing (2) occlusion/blockage of the pump (3) inadvertent catheter disconnection (4) swelling around the catheter site (5) bleeding or bruising around the catheter site (6) other complications | POD 1-4 | 
| Peri-operative complications | Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported | POD 30 | 
| Timed-up-and-go (TUG) test | TUG is a validated test to assess a person's mobility. It has been used to evaluate functional recovery after orthopedic surgeries. This will be administered on POD 14 at the surgeon's office during the post-operative follow-up visit | POD 14 |