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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Knee Disease; Opioid Use; Arthritis Knee

• Registration Number: NCT04648072
• Lead Sponsor: Health Sciences North Research Institute

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.

Study Timeline

• Study Start: 2020-11-04
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scoring on the Quality of Recovery-15 Survey	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	End of project	Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain	Throughout 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.
Range of Motion	Throughout hospital stay, an average of 1-2 days.	To be assessed by physiotherapy personnel twice daily while in hospital.
Time to Meet Discharge Criteria	Throughout 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.
Narcotic Consumption	Up 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.
Timed Up and Go (TUG) Test	Throughout hospital stay, an average of 1-2 days.	To be assessed by physiotherapy personnel twice daily while in hospital.

Trial Locations

Locations (1)

Health Sciences North; 🇨🇦 Sudbury, Ontario, Canada