Arthroplasty, Replacement, KneePhase 4TRUE KnORTH 2NCT06054750
Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty - A Feasibility Study
A Phase 4 study testing Ropivacaine and Normal saline in people with Arthroplasty, Replacement, Knee, run by McMaster University at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Ropivacaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2026to 15 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients presenting for a primary TKA.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Ropivacaine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)
Normal salineDrug
400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)
| Study group | Role | What they receive |
|---|---|---|
| cACB active | Experimental | Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication) Receives: Drug: Ropivacaine |
| cACB sham | Placebo comparator | Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline) Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 Survey scores
Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery
Measured: Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Secondary outcomes (11)
Quality of Recovery-15 Survey scores
Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery
Measured: 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
Measured: 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]
Measured: 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]
Measured: 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
Measured: 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)
Measured: 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
Measured: Postoperative day 42
Frequency of opioid-related side effects (vomiting and nausea)
Number of vomiting events or complaints of nausea noted in nursing notes
Measured: 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
Measured: 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
Measured: Postoperative day 42
Complications
- return to hospital once discharged for non-analgesic reasons ii. require more pain medications outside of prescription given
Measured: Postoperative days 10 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start15 Jan 2026
- Primary completion15 Feb 2026
- Study completion15 Mar 2026
Why it stopped: Unable to secure funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054750
- Sponsor's protocol ID
- TRUE KnORTH 2.0
- Acronym
- TRUE KnORTH 2
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty: Quality Of Recovery Through Patient Reporting - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06054750
- Acronym / sponsor ID
- TRUE KnORTH 2 / TRUE KnORTH 2.0
- Conditions
- Arthroplasty, Replacement, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| cACB active | Experimental | Drug: RopivacainePeriarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication) |
| cACB sham | Placebo comparator | Drug: Normal salinePeriarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients presenting for a primary TKA.
Key exclusion criteria (10 listed)
- Age <18 years;
- Body mass index ≥45 kg/m2;
- Weight <80 kg;
- Deemed unsuitable for regional anesthesia;
- Planned general anesthesia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume) | Drug | cACB active |
| Normal saline400 mL normal saline in continuous infusion adductor canal block (400 mL total volume) | Drug | cACB sham |
Primary outcome
Quality of Recovery-15 Survey scores
Time frame: Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery
11 secondary outcomes
Quality of Recovery-15 Survey scores
Time frame: Postoperative days 10 and 42
Brief Pain Inventory - Pain Interference scores
Time frame: Postoperative days 1, 2 and 3 in the morning
Pain Numerical Rating Scale at rest
Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Pain Numerical Rating Scale with activity
Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
Functional Recovery: Range of motion
Time frame: Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy
Functional Recovery: Time to reach discharge criteria
Time frame: 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 frame: Postoperative day 42
Frequency of opioid-related side effects (vomiting and nausea)
Time frame: Up to 3 days
Narcotic consumption in hospital
Time frame: Up to 3 days
Narcotic consumption at home
Time frame: Postoperative day 42
Complications
Time frame: Postoperative days 10 and 42
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Normal saline in people with Arthroplasty, Replacement, Knee, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 Survey scores (time frame: Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.