Knee OsteoarthritisTRUE KnORTHNCT04648072
How Does the Addition of Adductor Canal Block to Local Infiltration Affect Recovery in Patients Undergoing Total Knee Arthroplasty? A Feasibility Study.
A study testing Adductor Canal Block and Periarticular Injection in people with Knee Osteoarthritis and Arthritis Knee, run by Health Sciences North Research Institute at 1 site in Canada.
Trial summary
The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Arthritis Knee, Knee Disease
- What is being tested?
- Adductor Canal Block and Periarticular Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2020to 1 Dec 2021
- Phase
- Interventional
- 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
- Patients requiring primary total knee arthroplasty
- Patients interested in being part of the study
- Eligible to receive spinal anesthesia
Who cannot join
- Age < 18 years
- BMI > 40 kg/m2
- Deemed unsuitable for regional anesthesia
- Planned general anesthesia
- Hepatic insufficiency/Intolerance to acetaminophen
- Renal insufficiency (defined by eGFR <60)
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- 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)
- Sulpha allergy
- Allergy or intolerance to trial medications
- Clinical Frailty Scale Score > 4
- Surgery scheduled on a weekend
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Regional Anesthesia Techniques Resulting in up and Early Discharge Following Knee Surgery: An Opioid Reduction Plan for Transitional Pain at Home.
The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.
Read the detailed description
This study is a double blinded, randomized control trial. In order to create a blinded study, each participant will receive two injections; a single shot adductor canal block (ACB) and a periarticular injection (PI). All syringes will be non-identifiable to the surgeon, anesthetist and the patient.
Specifically, the two arms are:
Arm 1: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Ropivacaine)
Arm 2: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Normal Saline)
The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone. The investigators hypothesize that the addition of an adductor canal block will translate to a superior quality of recovery, as well as an improvement in functional return, discharge readiness and less short-term and long-term post-operative narcotic use.
- Conditions
- Knee Osteoarthritis, Arthritis Knee, Knee Disease, Opioid Use
- Being tested
- Adductor Canal Block, Periarticular Injection
- Keywords
- Quality of Recovery-15 Survey, Peripheral Nerve Block, Local Infiltration, Adductor Canal Block, Periarticular Injection, Regional Anesthesia, Total Knee Arthroplasty, Orthopedics, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockProcedure or surgery
As previously described.
Periarticular InjectionProcedure or surgery
As previously described.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular Injection + Adductor Canal Block (Local Anesthestic) | Experimental | The experimental arm with receive both the periarticular injection and the adductor canal block.
The periarticular injection will be performed by the surgeon and will consist of 100 mL of injectate being distributed in the following manner: 30 mL to the posterior capsule, 10 mL to the medial collateral ligament, 10mL to the lateral collateral ligament (ensuring not to infiltrate common peroneal nerve), 20mL to the quadriceps and anterior capsule, and 30 mL to the subcutaneous tissue. The periarticular injection will consist of 250 mg of ropivacaine, 30 mg of ketorolac, and 0.5 mg of epinephrine.
The adductor canal block will be completed by the anesthesiologist after spinal anesthesia has been initiated, but before the surgery commences. The block will be completed using an aseptic technique under dynamic, in-plane US guidance. 20 mL of injectate consisting of 100mg of ropivicaine and 50 mcg of epinephrine will be injected around the hyperechoic saphenous nerve. Receives: Procedure: Adductor Canal Block; Procedure: Periarticular Injection |
| Periarticular Injection + Adductor Canal Block (Normal Saline) | Placebo comparator | The control arm with receive a periarticular injection and a sham adductor canal block.
The periarticular injection will be carried out in the same manner as described for the experimental group. The technical aspects of the sham adductor canal block will be the same as for the experimental arm; however, the injectate will consist of 20 mL of normal saline. Receives: Procedure: Adductor Canal Block; Procedure: Periarticular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring on the Quality of Recovery-15 Survey
The Quality of Recovery-15 Survey is a validated patient-reported outcome questionnaire that measures the quality of recovery after surgery and anaesthesia. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). To be completed pre-operatively, and on POD#1, POD#10, and POD#28.
Measured: Up to 4 weeks post-operatively.
Feasibility Outcomes
Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention
Measured: End of project
Secondary outcomes (5)
Postoperative Pain
Pain will be assessed using the numeric rating scale (NRS) - an eleven point scale from 0 (no pain) to 10 (worst pain imaginable) - at rest and with movement. To be completed twice daily while in hospital.
Measured: Throughout hospital stay, an average of 1-2 days.
Range of Motion
To be assessed by physiotherapy personnel twice daily while in hospital.
Measured: Throughout hospital stay, an average of 1-2 days.
Time to Meet Discharge Criteria
Discharge criteria will be assessed by physiotherapy personnel and will include the ability to transfer in and out of bed independently, the ability to transfer on and off the toilet independently, the ability to ambulate independently with or without an assistive device for 50 meters, and the ability to do stairs if they are present in the patient's home environment. Time to meet discharge will be reported in half days. To be completed twice daily while in hospital.
Measured: Throughout hospital stay, an average of 1-2 days.
Narcotic Consumption
In hospital opioid consumption will be recorded and tracked by nursing personnel and will be assessed twice daily while in hospital. Post-discharge opioid consumption will be assessed using a questionnaire that will be administered by the Research Assistant over the phone. Corroboration of patient report will be completed by the Pharmacy Department. Post-discharge opioid consumption will be tracked on POD #10 and POD#28.
Measured: Up to 4 weeks post-operatively.
Timed Up and Go (TUG) Test
To be assessed by physiotherapy personnel twice daily while in hospital.
Measured: Throughout hospital stay, an average of 1-2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start4 Nov 2020
- Primary completion30 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial. Two arms of 30 participants will be included in this study. The experimental arm will receive both the periarticular injection and the adductor canal block with local anesthetic, while the control group will receive the periarticular injection and a sham adductor canal block with normal saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Sciences North Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Wong, M.D., Principal investigator, Health Sciences North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648072
- Sponsor's protocol ID
- TRUE KnORTH
- Acronym
- TRUE KnORTH
- Status last verified
- May 2023
- First submitted
- 9 Nov 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Regional Anesthesia Techniques Resulting in up and Early Discharge Following Knee Surgery: An Opioid Reduction Plan for Transitional Pain at Home.
- ClinicalTrials.gov ID
- NCT04648072
- Acronym / sponsor ID
- TRUE KnORTH / TRUE KnORTH
- Conditions
- Knee Osteoarthritis, Arthritis Knee, Knee Disease, Opioid Use
- Keywords
- Quality of Recovery-15 Survey, Peripheral Nerve Block, Local Infiltration, Adductor Canal Block, Periarticular Injection, Regional Anesthesia, Total Knee Arthroplasty, Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Health Sciences North Research InstituteUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Dec 2020 (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.
The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.
Detailed description
This study is a double blinded, randomized control trial. In order to create a blinded study, each participant will receive two injections; a single shot adductor canal block (ACB) and a periarticular injection (PI). All syringes will be non-identifiable to the surgeon, anesthetist and the patient.
Specifically, the two arms are:
Arm 1: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Ropivacaine)
Arm 2: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Normal Saline)
The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone. The investigators hypothesize that the addition of an adductor canal block will translate to a superior quality of recovery, as well as an improvement in functional return, discharge readiness and less short-term and long-term post-operative narcotic use.
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. Two arms of 30 participants will be included in this study. The experimental arm will receive both the periarticular injection and the adductor canal block with local anesthetic, while the control group will receive the periarticular injection and a sham adductor canal block with normal saline.
| Arm | Type | Receives |
|---|---|---|
| Periarticular Injection + Adductor Canal Block (Local Anesthestic) | Experimental | Procedure: Adductor Canal Block, Procedure: Periarticular InjectionThe experimental arm with receive both the periarticular injection and the adductor canal block. The periarticular injection will be performed by the surgeon and will consist of 100 mL of injectate being distributed in the following manner: 30 mL to the posterior capsule, 10 mL to the medial collateral ligament, 10mL to the lateral collateral ligament (ensuring not to infiltrate common peroneal nerve), 20mL to the quadriceps and anterior capsule, and 30 mL to the subcutaneous tissue. The periarticular injection will consist of 250 mg of ropivacaine, 30 mg of ketorolac, and 0.5 mg of epinephrine. The adductor canal block will be completed by the anesthesiologist after spinal anesthesia has been initiated, but before the surgery commences. The block will be completed using an aseptic technique under dynamic, in-plane US guidance. 20 mL of injectate consisting of 100mg of ropivicaine and 50 mcg of epinephrine will be injected around the hyperechoic saphenous nerve. |
| Periarticular Injection + Adductor Canal Block (Normal Saline) | Placebo comparator | Procedure: Adductor Canal Block, Procedure: Periarticular InjectionThe control arm with receive a periarticular injection and a sham adductor canal block. The periarticular injection will be carried out in the same manner as described for the experimental group. The technical aspects of the sham adductor canal block will be the same as for the experimental arm; however, the injectate will consist of 20 mL of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring primary total knee arthroplasty
- Patients interested in being part of the study
- Eligible to receive spinal anesthesia
Key exclusion criteria (11 listed)
- Age < 18 years
- BMI > 40 kg/m2
- Deemed unsuitable for regional anesthesia
- Planned general anesthesia
- Hepatic insufficiency/Intolerance to acetaminophen
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 |
|---|---|---|
| Adductor Canal BlockAs previously described. | Procedure or surgery | Periarticular Injection + Adductor Canal Block (Local Anesthestic), Periarticular Injection + Adductor Canal Block (Normal Saline) |
| Periarticular InjectionAs previously described. | Procedure or surgery | Periarticular Injection + Adductor Canal Block (Local Anesthestic), Periarticular Injection + Adductor Canal Block (Normal Saline) |
Primary outcome
Scoring on the Quality of Recovery-15 Survey
Time frame: Up to 4 weeks post-operatively.
The Quality of Recovery-15 Survey is a validated patient-reported outcome questionnaire that measures the quality of recovery after surgery and anaesthesia. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). To be completed pre-operatively, and on POD#1, POD#10, and POD#28.
Feasibility Outcomes
Time frame: End of project
Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention
5 secondary outcomes
Postoperative Pain
Time frame: Throughout hospital stay, an average of 1-2 days.
Range of Motion
Time frame: Throughout hospital stay, an average of 1-2 days.
Time to Meet Discharge Criteria
Time frame: Throughout hospital stay, an average of 1-2 days.
Narcotic Consumption
Time frame: Up to 4 weeks post-operatively.
Timed Up and Go (TUG) Test
Time frame: Throughout hospital stay, an average of 1-2 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kim Wong, M.D. principal investigator
Health Sciences North
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block and Periarticular Injection in people with Knee Osteoarthritis and Arthritis Knee, run by Health Sciences North Research Institute 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 5 Oct 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Scoring on the Quality of Recovery-15 Survey (time frame: Up to 4 weeks post-operatively.). The study lists 2 primary outcomes in all. 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 5 Oct 2026.