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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Opioid Use; Arthritis Knee; Knee Disease
• Intervention / Treatment: Procedure: Adductor Canal Block; Procedure: Periarticular Injection

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Wong, M.D.; Phone Number: 4733 705-523-7100; Email: skims214@gmail.com
• Study Contact Backup: Name: Kristen Sheffield, M.D.; Email: ksheffield@nosm.ca

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periarticular Injection + Adductor Canal Block (Local Anesthestic); 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.	Procedure: Adductor Canal Block; As previously described.; Procedure: Periarticular Injection; As previously described.
Placebo Comparator: Periarticular Injection + Adductor Canal Block (Normal Saline); 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.	Procedure: Adductor Canal Block; As previously described.; Procedure: Periarticular Injection; As previously described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 weeks post-operatively.
Feasibility Outcomes	Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention	End of project

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Throughout hospital stay, an average of 1-2 days.
Range of Motion	To be assessed by physiotherapy personnel twice daily while in hospital.	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.	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.	Up to 4 weeks post-operatively.
Timed Up and Go (TUG) Test	To be assessed by physiotherapy personnel twice daily while in hospital.	Throughout hospital stay, an average of 1-2 days.

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Health Sciences North Research Institute
• Collaborators: Dedicated Anesthesia Research Enhancement Grant
• Investigators: Principal Investigator: Kim Wong, M.D., Health Sciences North

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Regional Anesthesia; Orthopedics; Total Knee Replacement; Adductor Canal Block; Local Infiltration; Peripheral Nerve Block; Quality of Recovery-15 Survey; Periarticular Injection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TRUE KnORTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No