Ambulatory Surgical Procedures, Anesthesia, Regional, Arthroplasty, Replacement, Knee, Nerve Block
Conditions
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.
Interventions
DRUGNormal Saline
This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
DRUGRopivacaine
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
Sponsors
The Ottawa Hospital Academic Medical Association
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain score at rest | POD 1-4 + 7 | Patients will rate their pain on a scale of 0-10 |
| Pain score with activity | 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 |
| Patient satisfaction | POD 1-4 + 7 | Patients will be asked are you satisfied with your pain control |
| Quality of Recovery Scale 15 (QoR-15) | POD 2-4 + 7 | — |
| 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 |
| 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 |
| 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 |
| Vital signs - blood pressure, heart rate, oxygen saturation | twice daily POD 1-4 | These measurements will be obtained via post-operative home monitoring system |
Countries
Canada
Outcome results
None listed