Testing Regional anesthesia Techniques For Up And Early Discharge Following Knee arthroplasty - a Feasibility Study (TRUE KnORTH 2)

McMaster University

Status and phase: Not yet enrolling; Phase 4

Conditions: Arthroplasty, Replacement, Knee

Treatments: Drug: Normal saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06054750

TRUE KnORTH 2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 2 patient groups, including a placebo group

cACB active

Experimental group

Description:

Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication)

Treatment:

Drug: Ropivacaine

cACB sham

Placebo Comparator group

Description:

Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline)

Treatment:

Drug: Normal saline