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How Does the Addition of Adductor Canal Block to Local Infiltration Affect Recovery in Patients Undergoing Total Knee Arthroplasty? A Feasibility Study.

Total Regional Anesthesia Techniques Resulting in up and Early Discharge Following Knee Surgery: An Opioid Reduction Plan for Transitional Pain at Home.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04648072
Acronym
TRUE KnORTH
Enrollment
60
Registered
2020-12-01
Start date
2020-11-04
Completion date
2021-12-01
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, Total Knee Replacement

Brief 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. 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.

Interventions

PROCEDUREAdductor Canal Block

As previously described.

As previously described.

Sponsors

Dedicated Anesthesia Research Enhancement Grant
CollaboratorUNKNOWN
Health Sciences North Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Sealed envelopes.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients requiring primary total knee arthroplasty 2. Patients interested in being part of the study 3. Eligible to receive spinal anesthesia

Exclusion criteria

1. Age \< 18 years 2. BMI \> 40 kg/m2 3. Deemed unsuitable for regional anesthesia 4. Planned general anesthesia 5. Hepatic insufficiency/Intolerance to acetaminophen 6. Renal insufficiency (defined by eGFR \<60) 7. 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) 8. Sulpha allergy 9. Allergy or intolerance to trial medications 10. Clinical Frailty Scale Score \> 4 11. Surgery scheduled on a weekend

Design outcomes

Primary

MeasureTime frameDescription
Feasibility OutcomesEnd of projectDefined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention
Scoring on the Quality of Recovery-15 SurveyUp 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.

Secondary

MeasureTime frameDescription
Range of MotionThroughout hospital stay, an average of 1-2 days.To be assessed by physiotherapy personnel twice daily while in hospital.
Time to Meet Discharge CriteriaThroughout hospital stay, an average of 1-2 days.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.
Timed Up and Go (TUG) TestThroughout hospital stay, an average of 1-2 days.To be assessed by physiotherapy personnel twice daily while in hospital.
Narcotic ConsumptionUp to 4 weeks post-operatively.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.
Postoperative PainThroughout hospital stay, an average of 1-2 days.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.

Other

MeasureTime frameDescription
Opioid-Related Side Effects (Vomiting & Pruritus)Throughout hospital stay, an average of 1-2 days.Both vomiting and pruritic events will be assessed by nursing personnel daily while in hospital.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026