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Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)

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ClinicalTrials.gov 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
Sponsor:
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

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02060591


Contacts
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Contact: Tiffany Morrison, MS, CCRP 267-339-7818 tiffany.morrison@rothmaninstitute.com

Locations
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United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Tiffany Morrison, MS, CCRP    267-339-7818    tiffany.morrison@rothmaninstitute.com   
Sponsors and Collaborators
Rothman Institute Orthopaedics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02060591     History of Changes
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:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents