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

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee; Nerve Block; Anesthesia, Regional; Ambulatory Surgical Procedures
• Interventions: Drug: Normal Saline; Drug: Ropivacaine

• Registration Number: NCT03038425
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Study Start: 2017-05-02
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline infusion	Normal Saline	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
Ropivacaine infusion	Ropivacaine	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery Scale 15 (QoR-15)	POD 2-4 + 7
Pain score at rest	POD 1-4 + 7	Patients will rate their pain on a scale of 0-10
Tapentadol consumption	POD 1-4 + 7	Daily tapentadol use in milligrams
Pain score with activity	POD 1-4 + 7	Patients will rate their pain on a scale of 0-10
Patient-rated catheter effectiveness	POD 1-4	Patients will be asked "do you think the nerve block catheter is helpful? Rate on a 5-point scale"
Vital signs - blood pressure, heart rate, oxygen saturation	twice daily POD 1-4	These measurements will be obtained via post-operative home monitoring system
Catheter specific complications	POD 1-4	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
Peri-operative complications	POD 30	Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported
Patient satisfaction	POD 1-4 + 7	Patients will be asked "are you satisfied with your pain control"
Timed-up-and-go (TUG) test	POD 14	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

Trial Locations

Locations (1)

The Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada