Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Overview

This is a randomized prospective study of 60 patients undergoing total knee arthroplasty evaluating the clinical outcomes of liposomal bupivacaine periarticular injections (PAI) when compared to single shot adductor canal block using bupivacaine HCl.

Full Title of Study: “Clinical Outcomes of an Adductor Canal Block Versus Liposomal Bupivacaine in Total Knee Arthroplasty Patients: A Randomized Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 25, 2018

Detailed Description

Total knee arthroplasty(TKA) is an effective solution for end stage arthritis of the knee; however, post-surgical pain can be difficult to manage and the optimal peri-operative pain management strategy has not been established. This study serves to evaluate the clinical outcomes of liposomal bupivacaine PAI when compared to single shot adductor canal block using bupivacaine HCl in patients undergoing a TKA. The investigators hypothesized that peri-articular injection with liposomal bupivacaine would not be inferior to an adductor canal block using bupivacaine HCl. A total of 60 patients were recruited. Thirty patients were randomized to receive intraoperative liposomal bupivacaine periarticular injection, and another thirty patients randomized to receive a pre-operative adductor canal block using bupivacaine. Both groups otherwise received standard pain management strategies peri-operatively. The primary outcome of interest was post-operative pain, which was measured using the Visual Analog Scale (VAS). Secondary measures included changes in patient function which was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee range of motion, post-operative ambulation distance, and hospital length of stay.

Interventions

  • Procedure: Liposomal Bupivacaine Peri-articular Injection
    • A 20mL solution of 266mg of liposomal bupivacaine (Exparel) was mixed with 40mL of normal saline, which was then infiltrated consistently in the posterior capsule, medial and lateral side of the arthrotomy, patella tendon, quadriceps tendon, quadriceps musculature, and subcutaneous soft tissue.
  • Procedure: Adductor canal block
    • Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl

Arms, Groups and Cohorts

  • Active Comparator: Adductor Canal Block Group
    • Standard method for peri-operative pain control. Adductor canal block is performed by anesthesiologist prior to surgery.
  • Experimental: Liposomal Bupivacaine Group
    • Experimental method for peri-operative pain control. Liposomal bupivacaine peri-articular injection is performed by surgeon during surgery.

Clinical Trial Outcome Measures

Primary Measures

  • Visual Analog Scale (VAS)
    • Time Frame: VAS pain score on post-operative day #1
    • Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
  • Visual Analog Scale (VAS)
    • Time Frame: VAS pain score on post-operative day #2
    • Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
  • Visual Analog Scale (VAS)
    • Time Frame: VAS pain score on post-operative day #4
    • Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
  • Visual Analog Scale (VAS)
    • Time Frame: VAS pain score on post-operative day #7
    • Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

Secondary Measures

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    • Time Frame: Outcome measure will be assessed up to 8 weeks
    • Reported WOMAC Score ranges between 0 (worst) to 100 (best)
  • Knee range of motion
    • Time Frame: Outcome measure will be assessed up to 8 weeks
    • Knee flexion and extension will be recorded during follow up visits
  • Ambulation distance after surgery
    • Time Frame: Recorded on post-operative day #1
    • Distance walked in feet will be assessed and recorded by physical therapist
  • Hospital length of stay
    • Time Frame: Measure outcome will be assess through study completion, on average of 1 year
    • Measured by number of nights patient stayed in hospital after surgery

Participating in This Clinical Trial

Inclusion Criteria

1. Patients undergoing unilateral primary total knee arthroplasty for end stage osteoarthritis or rheumatoid arthritis.

2. All adults > 18 years of age.

Exclusion Criteria

1. Not cleared by PCP and appropriate specialists to undergo TKA (Check No if patient has been cleared.)

2. Adults undergoing bilateral primary total knee arthroplasties.

3. Women who are pregnant.

4. Women who are breastfeeding.

5. Inability to receive successful spinal anesthesia.

6. Allergy to amide anesthetics.

7. Inability to receive IV tranexamic acid.

8. Patients who are unable to speak English.

9. Patients who are less than 66kg.

10. Patients who are opioid dependent. We define opioid dependency as patients who are on a long-acting narcotic or patients who are taking more than six tablets of hydrocodone 5mg or equivalent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Good Samaritan Regional Medical Center, Oregon
  • Provider of Information About this Clinical Study
    • Principal Investigator: Justin Than, Orthopedic Resident – Good Samaritan Regional Medical Center, Oregon
  • Overall Official(s)
    • Justin Than, DO, Principal Investigator, Samaritan Health Services

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