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Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02739230
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
The goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and eliminate risks associated with catheters is the use of Exparel injection into the joint at the time of surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis: Joint Replacement Surgery Drug: Exparel Drug: On-Q pain intra-articular catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : December 2013
Actual Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exparel Injection Drug: Exparel
Active Comparator: On-Q intraarthicual catheter placement Drug: On-Q pain intra-articular catheter

Primary Outcome Measures :
  1. Total Morphine and morphine equivalent consumption [ Time Frame: 96 hours post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults scheduled to undergo primary total knee replacement
  2. Willing and able to provide informed consent
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Responsible Party: Rothman Institute Orthopaedics Identifier: NCT02739230    
Other Study ID Numbers: ESmith2016
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases