Multimodal Pain Management Following Primary TKA

August 14, 2023 updated by: Christopher Pelt, University of Utah

Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial

The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Early Phase 1

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
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic 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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 40 Years Old
  • Scheduled for Primary Total Knee Arthroplasty

Exclusion Criteria:

  • Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week)

  • Neuromuscular deficit affecting the lower limbs

    • Peripheral neuropathy
    • Radiculopathy/Sciatica
  • Known allergy or intolerance to Bupivacaine or Ropivacaine
  • Hepatic Disease
  • Renal Disease/Patients needing Dialysis
  • Planned unicompartmental knee replacement
  • Less than 90 degree of knee flexion preoperatively.
  • Patients who lack the capacity to consent or are unwilling to do so
  • At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: liposomal bupivacaine (LB) (Exparel)
Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Drug: Exparel
Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Active Comparator: Ropivacaine cocktail (PIC)
400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
Drug: Ropivacaine cocktail (PIC)
400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
Active Comparator: continuous femoral nerve blocks (cFNB)

Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.

Sciatic nerve block - 0.125% bupivacaine
Drug: Bupivacaine

Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.

Sciatic nerve block - 0.125% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discharge Readiness
Time Frame: Participants will be followed for the duration of hospital stay, an average of 3 days
Time to discharge readiness will be defined as the time from surgical stop to the time of the 2nd consecutive assessment where all criteria are fulfilled.
Participants will be followed for the duration of hospital stay, an average of 3 days

Collaborators and Investigators

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

Sponsor

University of Utah

Investigators

  • Principal Investigator: Christopher Pelt, M.D., University of Utah

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

September 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimated)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74975

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.

Subscribe