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

February 11, 2014 updated by: Rothman Institute Orthopaedics
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

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:

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

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exparel
Drug: Exparel
Active Comparator: Marcaine
Drug: Marcaine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Rothman Institute Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14PAR01

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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