COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management 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: NCT02060591
Recruitment Status : Unknown
Verified February 2014 by Rothman Institute Orthopaedics.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with Marcaine.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Drug: Exparel Drug: Marcaine Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Study Start Date : January 2014
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exparel Drug: Exparel
Active Comparator: Marcaine Drug: Marcaine

Primary Outcome Measures :
  1. 2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method [ Time Frame: Within first 30 days post-operatively ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.

Exclusion Criteria:

  • American Society of Anesthesiologist (ASA) score of 4 or higher
  • Hepatic disease (contraindication for acetaminophen)
  • Renal disease (contraindication for NSAIDs)
  • Any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, Tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol
  • Fibromyalgia
  • Any contraindication for intrathecal opioid injection
  • History of substance abuse during the last 2 years
  • History of allergy to amide compounds
  • Current consumption of monoaminoxidase (MAO) inhibitors and tricyclic antidepressant (TCA) medications
  • Allergy to metabisulfite compounds
  • Chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia)
  • Body weight<50 Kg, BMI>40 Kg/m2
  • History of hypotension
  • Patients with any surgery related complication in the first 4-6 weeks following TKA, such as infection or mechanical failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02060591

Layout table for location contacts
Contact: Tiffany Morrison, MS, CCRP 267-339-7818

Layout table for location information
United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Tiffany Morrison, MS, CCRP    267-339-7818   
Sponsors and Collaborators
Rothman Institute Orthopaedics
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rothman Institute Orthopaedics Identifier: NCT02060591    
Other Study ID Numbers: 14PAR01
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents