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

NCT ID: NCT02060591

Last Updated: 2014-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Groups

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Exparel

Group Type ACTIVE_COMPARATOR

Exparel

Intervention Type DRUG

Marcaine

Group Type ACTIVE_COMPARATOR

Marcaine

Intervention Type DRUG

Interventions

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Exparel

Intervention Type DRUG

Marcaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tiffany Morrison, MS, CCRP

Role: CONTACT

267-339-7818

Facility Contacts

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Tiffany Morrison, MS, CCRP

Role: primary

267-339-7818

References

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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.

Reference Type DERIVED
PMID: 27667533 (View on PubMed)

Other Identifiers

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14PAR01

Identifier Type: -

Identifier Source: org_study_id

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