Exparel vs Exparel Plus ACB in TKAs

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.

Key facts

Study ID

NCT02365727

Run by

The Hawkins Foundation

People needed

0

Starts

2015-04-01

Expected to finish

2015-08-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 18 to 80 years at the time of surgery.
• Willing and able to give voluntary informed consent to participate in this investigation.
• Candidate for total knee arthroplasty.
• BMI < 35.

You may not qualify if…

• Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
• Creatine level ≥ 1.5
• Pre-existing gait disturbance or neuropathy.
• Allergy to local anesthetics.
• Inflammatory arthropathies.
• Female patient who is pregnant or nursing.
• Chronic use of narcotics
• Any other reason (in the judgment of the investigator).

Where it is running

• Steadman Hawkins Clinic of the Carolinas - Greenville Health System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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