Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty: Quality Of Recovery Through Patient Reporting - a Feasibility Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- McMaster University
- Enrollment
- 226
- Locations
- 2
- Primary Endpoint
- Quality of Recovery-15 Survey scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Pharmacy will have access to the randomization scheme. All other members of the study team are blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
cACB active
Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication)
Intervention: Ropivacaine (Drug)
cACB sham
Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline)
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Quality of Recovery-15 Survey scores
Time Frame: 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 Outcomes
- Functional Recovery: Time to reach discharge criteria(Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy)
- Frequency of opioid-related side effects (vomiting and nausea)(Up to 3 days)
- Narcotic consumption at home(Postoperative day 42)
- Complications(Postoperative days 10 and 42)
- Quality of Recovery-15 Survey scores(Postoperative days 10 and 42)
- Pain Numerical Rating Scale at rest(Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3)
- Pain Numerical Rating Scale with activity(Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy)
- Narcotic consumption in hospital(Up to 3 days)
- Functional Recovery: Range of motion(Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy)
- Brief Pain Inventory - Pain Interference scores(Postoperative days 1, 2 and 3 in the morning)
- Functional Recovery: Timed Up and Go test(Postoperative day 42)