search
Back to results

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

Primary Purpose

Knee Osteoarthritis, Arthritis Knee, Knee Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adductor Canal Block
Periarticular Injection
Sponsored by
Health Sciences North Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Quality of Recovery-15 Survey, Peripheral Nerve Block, Local Infiltration, Adductor Canal Block, Periarticular Injection, Regional Anesthesia, Total Knee Arthroplasty, Orthopedics, Total Knee Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health Sciences North

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Periarticular Injection + Adductor Canal Block (Local Anesthestic)

Periarticular Injection + Adductor Canal Block (Normal Saline)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Range of Motion
To be assessed by physiotherapy personnel twice daily while in hospital.
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.
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.
Timed Up and Go (TUG) Test
To be assessed by physiotherapy personnel twice daily while in hospital.

Full Information

First Posted
November 9, 2020
Last Updated
May 3, 2023
Sponsor
Health Sciences North Research Institute
Collaborators
Dedicated Anesthesia Research Enhancement Grant
search

1. Study Identification

Unique Protocol Identification Number
NCT04648072
Brief Title
How Does the Addition of Adductor Canal Block to Local Infiltration Affect Recovery in Patients Undergoing Total Knee Arthroplasty? A Feasibility Study.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Sciences North Research Institute
Collaborators
Dedicated Anesthesia Research Enhancement Grant

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthritis Knee, Knee Disease, Opioid Use
Keywords
Quality of Recovery-15 Survey, Peripheral Nerve Block, Local Infiltration, Adductor Canal Block, Periarticular Injection, Regional Anesthesia, Total Knee Arthroplasty, Orthopedics, Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sealed envelopes.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periarticular Injection + Adductor Canal Block (Local Anesthestic)
Arm Type
Experimental
Arm Description
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.
Arm Title
Periarticular Injection + Adductor Canal Block (Normal Saline)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block
Intervention Description
As previously described.
Intervention Type
Procedure
Intervention Name(s)
Periarticular Injection
Intervention Description
As previously described.
Primary Outcome Measure Information:
Title
Scoring on the Quality of Recovery-15 Survey
Description
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.
Time Frame
Up to 4 weeks post-operatively.
Title
Feasibility Outcomes
Description
Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention
Time Frame
End of project
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
Throughout hospital stay, an average of 1-2 days.
Title
Range of Motion
Description
To be assessed by physiotherapy personnel twice daily while in hospital.
Time Frame
Throughout hospital stay, an average of 1-2 days.
Title
Time to Meet Discharge Criteria
Description
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.
Time Frame
Throughout hospital stay, an average of 1-2 days.
Title
Narcotic Consumption
Description
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.
Time Frame
Up to 4 weeks post-operatively.
Title
Timed Up and Go (TUG) Test
Description
To be assessed by physiotherapy personnel twice daily while in hospital.
Time Frame
Throughout hospital stay, an average of 1-2 days.
Other Pre-specified Outcome Measures:
Title
Opioid-Related Side Effects (Vomiting & Pruritus)
Description
Both vomiting and pruritic events will be assessed by nursing personnel daily while in hospital.
Time Frame
Throughout hospital stay, an average of 1-2 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Wong, M.D.
Organizational Affiliation
Health Sciences North
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs