Arthroplasty, Replacement, Knee
Conditions
Brief summary
To assess feasibility of a a trial investigation postoperative patient-reported quality of recovery after total knee arthroplasty (TKA) with periarticular joint injection (PAI) ± single shot adductor canal block with or without adductor canal catheter infusion.
Detailed description
Knee osteoarthritis (KOA) is a leading cause of chronic knee pain and disability, with a lifetime prevalence of 45%. Treatment for symptomatic KOA includes physical therapy, oral anti-inflammatory medications and intra-articular steroid injections, with total knee arthroplasty (TKA) (or knee replacement) as the definitive treatment. Acute postoperative pain is common after TKA, leading to increased opioid consumption and increased hospital length of stay. Pain control following TKA has been investigated with interventions such as intrathecal morphine, nerve blocks, and periarticular joint injection (PAI). PAI and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing TKA. The aim of this study is to assess postoperative patient-reported quality of recovery after TKA with PAI and single shot adductor canal block with or without adductor canal catheter infusion.
Interventions
DRUGRopivacaine
800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)
DRUGNormal saline
400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)
Sponsors
McMaster University
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacy will have access to the randomization scheme. All other members of the study team are blinded.
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients presenting for a primary TKA.
Exclusion criteria
* Age \<18 years; * Body mass index ≥45 kg/m2; * Weight \<80 kg; * Deemed unsuitable for regional anesthesia; * Planned general anesthesia; * Hepatic insufficiency/Intolerance to acetaminophen; * Renal insufficiency (defined by estimated glomerular filtration rate \<60 mL/min/1.73 m2); * Chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine per hour for greater than 1 month); * Allergy or intolerance to study medications (listed under 'Spinal and Adductor Canal Block') or trial medications listed in "Postoperative" section and "standard prescription" * Clinical Frailty Scale score ≥4;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 Survey scores | Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 | Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 Survey scores | Postoperative days 10 and 42 | Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery |
| Brief Pain Inventory - Pain Interference scores | Postoperative days 1, 2 and 3 in the morning | On a scale of 0-10, where 0=Does not interfere and 10=Completely interferes, Patients will rate how much their pain interferes with: General activity, Mood, Walking ability, Normal work including housework, Relations with other people, Sleep, and Enjoyment of life |
| Pain Numerical Rating Scale at rest | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 | Patient-reported pain measured on an 11-point scale from 0 \[no pain\] to 10 \[worst pain imaginable\] |
| Pain Numerical Rating Scale with activity | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy | Patient-reported pain measured on an 11-point scale from 0 \[no pain\] to 10 \[worst pain imaginable\] |
| Functional Recovery: Range of motion | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy | Flexion and Extension range of motion measured in degrees |
| Functional Recovery: Time to reach discharge criteria | Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy | Physiotherapist to assess when patient meets discharge criteria (measured in half days) |
| Functional Recovery: Timed Up and Go test | Postoperative day 42 | Time it takes for patient to stand up from sitting in a chair, walk 3 meters, then turn and walk back to chair and sit down, measured in seconds |
| Frequency of opioid-related side effects (vomiting and nausea) | Up to 3 days | Number of vomiting events or complaints of nausea noted in nursing notes |
| Narcotic consumption in hospital | Up to 3 days | total amount and route of administration collected from routine and PRN opioid use in PACU and on surgical floor - measured in mg of oral morphine equivalence |
| Narcotic consumption at home | Postoperative day 42 | Post-discharge opioid consumption will be tracked with pill count on POD 1 or 2, 3 POD10 (± 2 days), and POD42 (± 2 days); on POD 42 - patient to show study nurse how many pills remain to ensure reporting accuracy |
| Complications | Postoperative days 10 and 42 | i. return to hospital once discharged for non-analgesic reasons ii. require more pain medications outside of prescription given |
Countries
Canada
Outcome results
None listed