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

Knee Osteoarthritis Clinical Trial

— TRUE KnORTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648072
• Other study ID #: TRUE KnORTH
• Status: Completed
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2023
• Source: Health Sciences North Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis Knee
• Knee Disease
• Knee Osteoarthritis
• Opioid Use
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Adductor Canal Block
As previously described.
• Periarticular Injection
As previously described.

Locations

Country	Name	City	State
Canada	Health Sciences North	Sudbury	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Health Sciences North Research Institute	Dedicated Anesthesia Research Enhancement Grant

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	Feasibility Outcomes	Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention	End of project
Secondary	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.
Secondary	Range of Motion	To be assessed by physiotherapy personnel twice daily while in hospital.	Throughout hospital stay, an average of 1-2 days.
Secondary	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.
Secondary	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.
Secondary	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.