Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

— TRUE KnORTH 2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06054750
• Other study ID #: TRUE KnORTH 2.0
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 226
• Est. completion date: June 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Drug:
• Ropivacaine
800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)
• Normal saline
400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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