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Completed

NCT Number: NCT04648072

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Arthritis Knee Joint Diseases Knee Disease Musculoskeletal Diseases Opioid Use Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring primary total knee arthroplasty
  • Patients interested in being part of the study
  • Eligible to receive spinal anesthesia

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Adductor canal block

Procedure

As previously described.

Periarticular Injection

Procedure

As previously described.

Primary outcomes

  1. 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.

  2. Feasibility Outcomes

    Time frame: End of project

    Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention

Secondary outcomes

  1. Postoperative Pain

    Time frame: 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.

  2. Range of Motion

    Time frame: Throughout hospital stay, an average of 1-2 days.

    To be assessed by physiotherapy personnel twice daily while in hospital.

  3. Time to Meet Discharge Criteria

    Time frame: 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.

  4. Narcotic Consumption

    Time frame: 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.

  5. Timed Up and Go (TUG) Test

    Time frame: Throughout hospital stay, an average of 1-2 days.

    To be assessed by physiotherapy personnel twice daily while in hospital.

Other outcomes

  1. Opioid-Related Side Effects (Vomiting & Pruritus)

    Time frame: Throughout hospital stay, an average of 1-2 days.

    Both vomiting and pruritic events will be assessed by nursing personnel daily while in hospital.

Sponsors and collaborators

Lead sponsor

Health Sciences North Research Institute

Other

Collaborators

  • Dedicated Anesthesia Research Enhancement Grant

Registry information

Official study title

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

Acronym: TRUE KnORTH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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