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

NCT ID: NCT04648072

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2021-12-01

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.

Conditions

Knee Osteoarthritis; Arthritis Knee; Knee Disease; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adductor Canal Block

Intervention Type: PROCEDURE

As previously described.

Periarticular Injection

Intervention Type: PROCEDURE

As previously described.

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.

Group Type: PLACEBO_COMPARATOR

Adductor Canal Block

Intervention Type: PROCEDURE

As previously described.

Periarticular Injection

Intervention Type: PROCEDURE

As previously described.

Interventions

Adductor Canal Block

As previously described.

Intervention Type: PROCEDURE

Periarticular Injection

As previously described.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dedicated Anesthesia Research Enhancement Grant

UNKNOWN

Sponsor Role: collaborator

Health Sciences North Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Kim Wong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim Wong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Health Sciences North

Locations

Health Sciences North

Greater Sudbury, Ontario, Canada

Countries

Canada

Other Identifiers

TRUE KnORTH

Identifier Type: -

Identifier Source: org_study_id