Adductor Canal Block Versus Liposomal Bupivacaine in TKA

September 9, 2019 updated by: Justin Than, Good Samaritan Regional Medical Center, Oregon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adductor Canal Block Group
Standard method for peri-operative pain control. Adductor canal block is performed by anesthesiologist prior to surgery.
Procedure: Adductor canal block
Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl
Experimental: Liposomal Bupivacaine Group
Experimental method for peri-operative pain control. Liposomal bupivacaine peri-articular injection is performed by surgeon during surgery.
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.
Other Names:
  • Exparel peri-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
VAS pain score on post-operative day #1
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)
VAS pain score on post-operative day #2
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)
VAS pain score on post-operative day #4
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)
VAS pain score on post-operative day #7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Outcome measure will be assessed up to 8 weeks
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
Outcome measure will be assessed up to 8 weeks
Ambulation distance after surgery
Time Frame: Recorded on post-operative day #1
Distance walked in feet will be assessed and recorded by physical therapist
Recorded on post-operative day #1
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
Measure outcome will be assess through study completion, on average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Good Samaritan Regional Medical Center, Oregon

Investigators

  • Principal Investigator: Justin Than, DO, Samaritan Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Actual)

November 25, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Individual participant data to be available up to 7 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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