Evaluation Exparel Delivered in Knee Replacement

Completed · Phase 4

Conditions studied: Arthritis

In brief

Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief. Hypothesis: There is no difference in, the use of analgesics or the length and quality of analgesia and no decrease in the time to be able to accomplish simple to complex knee movements using Exparel infiltration when compared to controls.

Key facts

Study ID

NCT02011464

Run by

Maimonides Medical Center

People needed

20

Starts

2013-12-01

Expected to finish

2015-09-01

Last updated by the study team

2017-08-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3
• Patients undergoing knee replacement (total knee arthroplasty)
• Subjects must be physically and mentally able to participate in the study and complete all study assessments.
• Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.

You may not qualify if…

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee.
• Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
• Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s.
• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
• History of pre-existing neurological disorders/neuropathy
• Morbid Obesity

Where it is running

• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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