- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02739230
Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)
April 14, 2016 updated by: Rothman Institute Orthopaedics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults scheduled to undergo primary total knee replacement
- Willing and able to provide informed consent
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
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exparel Injection
|
|
Active Comparator: On-Q intraarthicual catheter placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Morphine and morphine equivalent consumption
Time Frame: 96 hours post-op
|
96 hours post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
April 7, 2016
First Submitted That Met QC Criteria
April 14, 2016
First Posted (Estimate)
April 15, 2016
Study Record Updates
Last Update Posted (Estimate)
April 15, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESmith2016
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.
Clinical Trials on Osteoarthritis: Joint Replacement Surgery
-
Tissue Tech Inc.WithdrawnOsteoarthritis: Joint Replacement SurgeryUnited States
-
Baxter Healthcare CorporationCompletedOsteoarthritis | Knee Replacement SurgeryUnited States
-
Derek AmanatullahCompletedTotal Joint Replacement SurgeryUnited States
-
Derek AmanatullahTerminatedTotal Joint Replacement SurgeryUnited States
-
Chad BrummettNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingOsteoarthritis, Knee | Knee Replacement SurgeryUnited States
-
Novartis PharmaceuticalsCompletedPrimary Osteoarthritis Patients Scheduled for Total Knee Replacement SurgeryUnited States
-
University College, LondonStryker InstrumentsRecruitingOsteo Arthritis Knee | Surgery | Unicompartmental Knee ReplacementUnited Kingdom
-
NYU Langone HealthCompleted
-
Yeditepe UniversityCompletedKnee Osteoarthritis | Arthroplasty | Joint ReplacementTurkey
-
Northern Orthopaedic Division, DenmarkAalborg UniversityCompletedOsteoarthritis, Knee | Osteoarthritis, Hip | Arthroplasty, Replacement, Knee | Artificial Intelligence | Arthroplasty, Replacement, Hip | Decision Making, SharedDenmark
Clinical Trials on Exparel
-
Pacira Pharmaceuticals, IncCompletedPostoperative Pain ManagementUnited States
-
Pacira Pharmaceuticals, IncTerminatedPostoperative Pain ManagementUnited States
-
Texas Tech University Health Sciences CenterNot yet recruiting
-
Spectrum Health HospitalsCompletedPostoperative PainUnited States
-
Pacira Pharmaceuticals, IncCompleted
-
OrthoCarolina Research Institute, Inc.Pacira Pharmaceuticals, IncCompletedAnkle Arthrodesis | Hindfoot Arthrodesis | Tibitalocalceal ArthrodesisUnited States
-
Mayo ClinicSusan G. Komen Breast Cancer FoundationCompleted
-
Pacira Pharmaceuticals, IncCompletedPain Management | Spinal FusionUnited States
-
Children's Hospital of Orange CountyRecruitingPain | Anxiety | ACL Tear | Opioid MisuseUnited States