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| Name | Class |
|---|---|
| The Ottawa Hospital Academic Medical Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline infusion | Placebo Comparator | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Scale 15 (QoR-15) | POD 2-4 + 7 | |
| Pain score at rest | Patients will rate their pain on a scale of 0-10 | POD 1-4 + 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick BY Wong, MD | The Ottawa Hospital, University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
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| Ropivacaine | Drug | 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 |
|
| Pain score with activity |
Patients will rate their pain on a scale of 0-10 |
| POD 1-4 + 7 |
| Tapentadol consumption | Daily tapentadol use in milligrams | POD 1-4 + 7 |
| Patient satisfaction | Patients will be asked "are you satisfied with your pain control" | POD 1-4 + 7 |
| Vital signs - blood pressure, heart rate, oxygen saturation | These measurements will be obtained via post-operative home monitoring system | twice daily POD 1-4 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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