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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Ambulatory Surgical Procedures; Nerve Block; Anesthesia, Regional
• Intervention / Treatment: Drug: Normal Saline; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital, General Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. patient characteristics suitable for subvastus approach as determined by single surgeon
2. patients willing to undergo ambulatory surgery
3. ability to read and verbally communicate via either English or French

Exclusion Criteria:

1. age > 80
2. driving distance greater than 1 hour from hospital
3. no willing caregiver at home on night of surgery
4. renal failure requiring dialysis
5. Insulin-dependent diabetes mellitus
6. BMI > 45
7. allergy to study medications
8. pre-existing neurologic deficit involving the ipsilateral limb
9. chronic high dose opioid use (defined as >200mg/day of morphine equivalent for over 2 weeks).
10. inability to use or manage cACB catheter and pump independently at home
11. inability or refusal to cryocompressive therapy device.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline infusion; 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; This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
Active Comparator: Ropivacaine infusion; 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; 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

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Ottawa Hospital Academic Medical Association
• Investigators: Principal Investigator: Patrick BY Wong, MD, The Ottawa Hospital, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 20160937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No