Clinical trial NCT06054750: Testing Regional anesthesia Techniques For Up And Early Discharge Following Knee arthroplasty - a Feasibility Study
Official title: Testing Regional anesthesia Techniques For Up And Early Discharge Following Knee arthroplasty: Quality Of Recovery Through Patient Reporting - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Quality of Recovery-15 Survey scores
timeFrame: Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Secondary outcomes:
measure: Quality of Recovery-15 Survey scores
timeFrame: Postoperative days 10 and 42
measure: Brief Pain Inventory - Pain Interference scores
timeFrame: Postoperative days 1, 2 and 3 in the morning
measure: Pain Numerical Rating Scale at rest
timeFrame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
measure: Pain Numerical Rating Scale with activity
timeFrame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
measure: Functional Recovery: Range of motion
timeFrame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
measure: Functional Recovery: Time to reach discharge criteria
timeFrame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
measure: Functional Recovery: Timed Up and Go test
timeFrame: Postoperative day 42
measure: Frequency of opioid-related side effects (vomiting and nausea)
timeFrame: Up to 3 days
measure: Narcotic consumption in hospital
timeFrame: Up to 3 days
measure: Narcotic consumption at home
timeFrame: Postoperative day 42
measure: Complications
timeFrame: Postoperative days 10 and 42
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: