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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060591
Enrollment
Unknown
Registered
2014-02-12
Start date
2014-01-31
Completion date
Unknown
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

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.

Interventions

DRUGExparel

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) methodWithin first 30 days post-operatively

Countries

United States

Contacts

Primary ContactTiffany Morrison, MS, CCRP
tiffany.morrison@rothmaninstitute.com267-339-7818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026