Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedFebruary 12, 2014
February 1, 2014
1 year
February 10, 2014
February 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method
Within first 30 days post-operatively
Study Arms (2)
Exparel
ACTIVE COMPARATORMarcaine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Alijanipour P, Tan TL, Matthews CN, Viola JR, Purtill JJ, Rothman RH, Parvizi J, Austin MS. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial. J Arthroplasty. 2017 Feb;32(2):628-634. doi: 10.1016/j.arth.2016.07.023. Epub 2016 Aug 9.
PMID: 27667533DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 12, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Last Updated
February 12, 2014
Record last verified: 2014-02