Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty - A Feasibility Study (TRUE KnORTH 2)

Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty: Quality Of Recovery Through Patient Reporting - a Feasibility Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Drug: Ropivacaine; Drug: Normal saline

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cACB active; Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication)	Drug: Ropivacaine; 800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)
Placebo Comparator: cACB sham; Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline)	Drug: Normal saline; 400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 Survey scores	Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery	Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 Survey scores	Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery	Postoperative days 10 and 42
Brief Pain Inventory - Pain Interference scores	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	Postoperative days 1, 2 and 3 in the morning
Pain Numerical Rating Scale at rest	Patient-reported pain measured on an 11-point scale from 0 [no pain] to 10 [worst pain imaginable]	Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Pain Numerical Rating Scale with activity	Patient-reported pain measured on an 11-point scale from 0 [no pain] to 10 [worst pain imaginable]	Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
Functional Recovery: Range of motion	Flexion and Extension range of motion measured in degrees	Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
Functional Recovery: Time to reach discharge criteria	Physiotherapist to assess when patient meets discharge criteria (measured in half days)	Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
Functional Recovery: Timed Up and Go test	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	Postoperative day 42
Frequency of opioid-related side effects (vomiting and nausea)	Number of vomiting events or complaints of nausea noted in nursing notes	Up to 3 days
Narcotic consumption in hospital	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	Up to 3 days
Narcotic consumption at home	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	Postoperative day 42
Complications	i. return to hospital once discharged for non-analgesic reasons ii. require more pain medications outside of prescription given	Postoperative days 10 and 42

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Actual): February 15, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Ropivacaine; Saline Solution
• Other Study ID Numbers: TRUE KnORTH 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: On reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No