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

NCT04648072 | Completed

• 1 other identifier: TRUE KnORTH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

• Feasibility Outcomes

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

  End of project

Secondary Outcomes (5)

• Postoperative Pain

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

• Range of Motion

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

• Time to Meet Discharge Criteria

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

• Narcotic Consumption

  Up to 4 weeks post-operatively.

• Timed Up and Go (TUG) Test

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

Other Outcomes (1)

• Opioid-Related Side Effects (Vomiting & Pruritus)

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

Study Arms (2)

Periarticular Injection + Adductor Canal Block (Local Anesthestic)

EXPERIMENTAL

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; Procedure: Periarticular Injection

Periarticular Injection + Adductor Canal Block (Normal Saline)

PLACEBO COMPARATOR

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; Procedure: Periarticular Injection

Interventions

Adductor Canal Block PROCEDURE

As previously described.

Periarticular Injection + Adductor Canal Block (Local Anesthestic); Periarticular Injection + Adductor Canal Block (Normal Saline)

Periarticular Injection PROCEDURE

As previously described.

Periarticular Injection + Adductor Canal Block (Local Anesthestic); Periarticular Injection + Adductor Canal Block (Normal Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Health Sciences North Research Institute: lead
• Dedicated Anesthesia Research Enhancement Grant: collaborator

Study Sites (1)

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kim Wong, M.D.

  Health Sciences North

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 1, 2020
• Study Start: November 4, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 1, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)