Arthroplasty, Replacement, Knee Clinical Trial
Official title:
Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
NCT number | NCT03038425 |
Other study ID # | 20160937 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2017 |
Est. completion date | April 1, 2020 |
Verified date | December 2020 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital, General Campus | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | The Ottawa Hospital Academic Medical Association |
Canada,
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 |
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