Clinical trial NCT03038425: Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
Official title: Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Nerve Block
Anesthesia, Regional
Ambulatory Surgical Procedures
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital Academic Medical Association
First posted: 2017-01-31
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Recovery Scale 15 (QoR-15)
timeFrame: at 4pm on post-operative day (POD) 1
Secondary outcomes:
measure: Quality of Recovery Scale 15 (QoR-15)
timeFrame: POD 2-4 + 7
measure: Pain score at rest
timeFrame: POD 1-4 + 7
measure: Pain score with activity
timeFrame: POD 1-4 + 7
measure: Tapentadol consumption
timeFrame: POD 1-4 + 7
measure: Patient satisfaction
timeFrame: POD 1-4 + 7
measure: Vital signs - blood pressure, heart rate, oxygen saturation
timeFrame: twice daily POD 1-4
measure: Patient-rated catheter effectiveness
timeFrame: POD 1-4
measure: Catheter specific complications
timeFrame: POD 1-4
measure: Peri-operative complications
timeFrame: POD 30
measure: Timed-up-and-go (TUG) test
timeFrame: POD 14
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: The Ottawa Hospital, University of Ottawa
name: Patrick BY Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: