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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038425
• Other study ID #: 20160937
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: December 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Anesthesia, Regional
• Arthroplasty, Replacement, Knee
• Nerve Block

Intervention

Drug:
• Normal Saline
This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
• 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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital Academic Medical Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Recovery Scale 15 (QoR-15)		POD 2-4 + 7
Secondary	Pain score at rest	Patients will rate their pain on a scale of 0-10	POD 1-4 + 7
Secondary	Pain score with activity	Patients will rate their pain on a scale of 0-10	POD 1-4 + 7
Secondary	Tapentadol consumption	Daily tapentadol use in milligrams	POD 1-4 + 7
Secondary	Patient satisfaction	Patients will be asked "are you satisfied with your pain control"	POD 1-4 + 7
Secondary	Vital signs - blood pressure, heart rate, oxygen saturation	These measurements will be obtained via post-operative home monitoring system	twice daily POD 1-4
Secondary	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
Secondary	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
Secondary	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
Secondary	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