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

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ClinicalTrials.gov Identifier: NCT04648072
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
Dedicated Anesthesia Research Enhancement Grant
Information provided by (Responsible Party):
Kristen Sheffield, Northern Ontario School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Arthritis Knee Knee Disease Opioid Use Procedure: Adductor Canal Block Procedure: Periarticular Injection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sealed envelopes.
Primary Purpose: Treatment
Official Title: Total Regional Anesthesia Techniques Resulting in up and Early Discharge Following Knee Surgery: An Opioid Reduction Plan for Transitional Pain at Home.
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648072


Contacts
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Contact: Kim Wong, M.D. 705-523-7100 ext 4733 skims214@gmail.com
Contact: Kristen Sheffield, M.D. ksheffield@nosm.ca

Locations
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Canada, Ontario
Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Kristen Sheffield, MSc., M.D.       ksheffield@nosm.ca   
Contact: Kim Wong, M.D.       skims214@gmail.com   
Sponsors and Collaborators
Health Sciences North Research Institute
Dedicated Anesthesia Research Enhancement Grant
Investigators
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Principal Investigator: Kim Wong, M.D. Health Sciences North
More Information
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Responsible Party: Kristen Sheffield, Principal Investigator, Northern Ontario School of Medicine
ClinicalTrials.gov Identifier: NCT04648072    
Other Study ID Numbers: TRUE KnORTH
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristen Sheffield, Northern Ontario School of Medicine:
Quality of Recovery-15 Survey
Peripheral Nerve Block
Local Infiltration
Adductor Canal Block
Periarticular Injection
 Regional Anesthesia
Total Knee Arthroplasty
Orthopedics
Total Knee Replacement
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases