Continuous Femoral Nerve Block Following Total Knee Replacement
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if putting local anesthetic-or numbing
      medication-through a tiny tube next to the nerves that go to the knee will improve pain
      control during physical therapy, and ultimately improve the results of surgery. It will also
      determine if patients having knee replacement surgery may receive the same or better pain
      control at home compared with staying in the hospital, and if this improves their experience
      following surgery.
    

Detailed description: 
      What procedures would be done as part of your normal clinical care (even if you did not
      participate in this research)?

      You will have some monitors placed (such as a blood-pressure cuff) and be given some
      medicines through your intravenous (IV) line to make you very sleepy. The anesthesiologist
      will then place a nerve block so that much of your knee (not all) will be numb. At the same
      time, the anesthesiologist will place a tiny tube, called a catheter, near your nerves that
      will be used after the surgery is over. You will still go to sleep for the surgery, but you
      will be much more comfortable when you wake up because the numbing medicine will be working
      to take away much of the pain. If you are not part of this study, you would go from the
      recovery room to a room in the hospital for 3-5 days, and your catheter would be removed the
      morning following surgery. After your catheter was removed, you would depend on oral and IV
      opioids-or pain medicine-to control your surgical pain. You would go home with only oral
      opioids since IV opioids cannot be provided at home.

      What procedures will be done only because you are participating in this research study?

      From the recovery room you will go to the Clinical Research Center (CRC) which is a special
      part of the hospital where research is undertaken. During your stay at the CRC you will have
      the ability to push a button on a small infusion pump to give yourself more medicine through
      the tube to your nerves if you have pain. If this does not help enough, you will take pain
      pills to help. And if this does not help enough, you will be given opioids (strong pain
      medicine like morphine) into your IV. Each morning after surgery, the medicine in your little
      infusion pump will be replaced by either (1) more medicine, or (2) salt water, or "normal
      saline". The pharmacist will determine this randomly-like flipping a coin-and neither you nor
      the doctors/nurses caring for you will know which you have. This is to keep any of us from
      inadvertently/unconsciously affecting the results of the study. However, if you have pain
      that is not controlled with pain pills, you will be switched back to the regular medicine to
      improve your comfort until the following morning. You will undergo physical therapy and
      following this you will be checked to see if you are ready to go home. When you are ready to
      go home beginning on the third day after surgery, you may go home with the little infusion
      pump and the tube that goes to the nerves of your knee. One of the study physicians will call
      you each night to ensure that you are comfortable for the first 7 nights after your surgery,
      and you will be given the phone and pager numbers of a physician available for you to contact
      24 hours/day, 7 days/week. When the medicine runs out or in the fourth evening following
      surgery, whichever comes first, your catheter will be removed. The pump is disposable, so it
      can be thrown away. A physician will call you the two nights after the catheter comes out to
      ensure that you are comfortable.
    

Intervention name(s): Femoral perineural infusion
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty secondary to osteoarthritis