Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty

This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.

Study Overview

Study Type

Interventional

Enrollment (Actual)

63

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

    • Texas
      • Austin, Texas, United States, 78759
        • Texas Orthopedics

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non-pregnant female between the ages of 18-65
  • Patients willing and able to sign the informed consent
  • Patients able to comply with follow-up requirements including self-evaluations
  • Patients requiring a primary total knee replacement
  • Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis

Exclusion Criteria:

  • Revision total knee arthroplasty
  • Bilateral total knee arthroplasty
  • Patients with inflammatory arthritis
  • Patients with a body mass index (BMI) > 40
  • Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
  • Current use of opioid drugs
  • Patients with a history of total or unicompartmental reconstruction of the affected joint
  • Patients that have had a high tibial osteotomy or femoral osteotomy
  • Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
  • Patients with a systemic or metabolic disorder leading to progressive bone deterioration
  • Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers
  • Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
  • Patients with knee fusion to the affected joint
  • Patients with an active or suspected latent infection in or about the knee joint
  • Patients that are prisoners

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: Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants
Other Names:
  • Exparel
Other Names:
  • Marcaine
Active Comparator: Adductor canal and tibial nerve block
Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour
Other Names:
  • Naropin
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of stay (LOS, in days)
Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
Time to ambulation (in hours)
Time Frame: 2-6 hours
2-6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain as assessed by visual analog scale (VAS) on postoperative day 0
Time Frame: 6 hours
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
6 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 1
Time Frame: 24 hours
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
24 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 2
Time Frame: 48 hours
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
48 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 3
Time Frame: 72 hours
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
72 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 4
Time Frame: 96 hours
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
96 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 5
Time Frame: 120 hours
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
120 hours
Opioid consumption in oral morphine equivalents (OMEs, in milligrams)
Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
Postoperative complications and adverse events
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Tyler D Goldberg, MD, Texas Orthopedics

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)

July 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

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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