Liposomal Bupivacaine in Total Knee Arthroplasty

March 18, 2016 updated by: Miller Orthopedic Specialists

Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty

Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Miller Orthopedic Specialists

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial

Exclusion Criteria:

  • Patients with a sensitivity to marcaine
  • Pregnant or lactating women
  • Non-English speaking individuals

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants
Drug: Liposomal bupivacaine
Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline
Other Names:
  • Exparel
ACTIVE_COMPARATOR: bupivacaine HCl, morphine, epinephrine, methylprednisolone
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants
Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean visual analog scale (VAS) pain scores
Time Frame: Night of surgery
Self-reported pain scores from 0=no pain to 10=severe pain
Night of surgery
Mean visual analog scale (VAS) pain scores
Time Frame: Post-operative day 1
Self-reported pain scores from 0=no pain to 10=severe pain
Post-operative day 1
Mean visual analog scale (VAS) pain scores
Time Frame: Post-operative day 2
Self-reported pain scores from 0=no pain to 10=severe pain
Post-operative day 2
Pain assessment phone call
Time Frame: Post-operative day 3
Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.
Post-operative day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.
Number of patients with complications
Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.

Collaborators and Investigators

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

Sponsor

Miller Orthopedic Specialists

Collaborators

CHI Health Mercy Hospital
Creighton University Medical Center

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

June 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (ESTIMATE)

April 24, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 633913

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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