Exparel vs Exparel Plus ACB in TKAs

January 13, 2016 updated by: The Hawkins Foundation

Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty

Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.

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Withdrawn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
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Steadman Hawkins Clinic of the Carolinas - Greenville Health System

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 18 to 80 years at the time of surgery.
  • Willing and able to give voluntary informed consent to participate in this investigation.
  • Candidate for total knee arthroplasty.
  • BMI < 35.

Exclusion Criteria:

  • Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
  • Creatine level ≥ 1.5
  • Pre-existing gait disturbance or neuropathy.
  • Allergy to local anesthetics.
  • Inflammatory arthropathies.
  • Female patient who is pregnant or nursing.
  • Chronic use of narcotics
  • Any other reason (in the judgment of the investigator).

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exparel plus Adductor Canal Block
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
Drug: Clonidine
Drug: Ropivacaine
Drug: Epinephrine
Drug: Liposomal bupivacaine
Other Names:
  • Exparel
Placebo Comparator: Exparel plus Placebo Block
Adductor canal block with 20 cc saline
Drug: Saline
Drug: Liposomal bupivacaine
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain as assessed by Visual Analog Scale (VAS)
Time Frame: 12 Months
Pain, as assessed by Visual Analog Scale (VAS)
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function as assessed by Knee Society Score (KSS) and EQ-5D
Time Frame: 12 Months
Function, as assessed by Knee Society Score (KSS) and EQ-5D
12 Months
Opioid consumption as assessed by dosage and frequency of narcotic usage
Time Frame: 30 hours
Opioid consumption, as assessed by dosage and frequency of narcotic usage
30 hours

Collaborators and Investigators

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

Sponsor

The Hawkins Foundation

Investigators

  • Principal Investigator: Brayton Shirley, Steadman Hawkins Clinic of the Carolinas - Greenville Health System

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

April 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00034356

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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