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WithdrawnNCT06054750TRUE KnORTH 2Updated Jun 4, 2026

Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty - A Feasibility Study

A Phase 4 interventional study of Ropivacaine and Normal saline in Arthroplasty, Replacement, Knee, sponsored by McMaster University. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by McMaster University · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Unable to secure funding.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Arthroplasty, Replacement, Knee
03

In context

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All adult patients presenting for a primary TKA.

Exclusion criteria

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;
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    cACB active

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

    Drug: Ropivacaine

  • Placebo comparator
    cACB sham

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

    Drug: Normal saline

Interventions

  • DrugRopivacaine

    800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)

  • DrugNormal saline

    400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)

06

What researchers measure

Primary outcomes

  1. Quality of Recovery-15 Survey scores

    Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery

    Time frame: Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3

Secondary outcomes

  1. Quality of Recovery-15 Survey scores

    Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery

    Time frame: Postoperative days 10 and 42

  2. 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

    Time frame: Postoperative days 1, 2 and 3 in the morning

  3. Pain Numerical Rating Scale at rest

    Patient-reported pain measured on an 11-point scale from 0 \[no pain\] to 10 \[worst pain imaginable\]

    Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3

  4. Pain Numerical Rating Scale with activity

    Patient-reported pain measured on an 11-point scale from 0 \[no pain\] to 10 \[worst pain imaginable\]

    Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy

  5. Functional Recovery: Range of motion

    Flexion and Extension range of motion measured in degrees

    Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy

  6. Functional Recovery: Time to reach discharge criteria

    Physiotherapist to assess when patient meets discharge criteria (measured in half days)

    Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy

  7. 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

    Time frame: Postoperative day 42

  8. Frequency of opioid-related side effects (vomiting and nausea)

    Number of vomiting events or complaints of nausea noted in nursing notes

    Time frame: Up to 3 days

  9. 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

    Time frame: Up to 3 days

  10. 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

    Time frame: Postoperative day 42

  11. Complications

    i. return to hospital once discharged for non-analgesic reasons ii. require more pain medications outside of prescription given

    Time frame: Postoperative days 10 and 42

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Study locations

1 site
  • St Joseph's Healthcare Hamilton
    Hamilton, Ontario L8N 4A6, Canada
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06054750
Lead sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
Responsible party
Sponsor
First posted
Sep 26, 2023
Start date
Jan 15, 2026
Primary completion
Feb 15, 2026
Completion
Mar 15, 2026
Last update
Jun 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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