Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Replacement
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      To determine if following total knee replacement, putting local anesthetic-or numbing
      medication-for five days through a tiny tube next to the nerves that go to the knee will
      decrease the time that patients need to spend in the hospital.
    

Detailed description: 
      1. Procedures that will be done as part of your normal clinical care (even if you do 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 line to make you very sleepy. The anesthesiologist
           will then place a tiny tube, called a catheter, near your nerves that will be used
           during and following surgery. This involves carefully cleaning the immediate area in the
           upper thigh where the catheter will be placed, numbing the site of the catheter with
           local anesthetic placed just under the skin, placing a needle through the skin that is
           numbed to an area near where your nerves are, putting the catheter through the needle so
           that the tip is next to your nerves, then removing the needle leaving the catheter in
           place. You can still go to sleep for the surgery, but you will be 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 probably be removed the morning after
           surgery. After removal of your catheter, you would depend on oral and intravenous pain
           medicine ("opioids"-like morphine) to control your surgical pain. You would go home with
           only oral opioids since intravenous opioids cannot be provided at home.

        2. Procedures that will be done only if you participate in this research study:

           From the recovery room you will go to the surgical ward. During your stay in the
           hospital you will have the ability to push a button on a small infusion pump-a little
           device that holds and puts the medicine through the catheter to bath your nerves in
           local anesthetic-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 intravenous line.

        3. On the 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.

        4. You will undergo physical therapy and following this you will be checked to see if you
           are ready to go home. This will include walking in the morning and afternoon with a
           physical therapist. 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 delivers the
           fluid. You will be given a prescription for pain pills in case you need them for pain
           relief.

        5. One of the study investigators will call you each night to ensure that you are
           comfortable for the first 6 nights after your surgery, and you will be given the phone
           and pager numbers of your physician (anesthesiologist) available for you to contact 24
           hours/day, 7 days/week. A research nurse will call you for five nights beginning the day
           after surgery to ask about your comfort level and other study-related information such
           as your satisfaction level.

        6. On the fourth evening following surgery your catheter will be removed. You have two
           options available to you to remove your catheter. You can call a physician who will talk
           you or your caregiver through this process over the phone--it will not hurt or bleed.
           Your other option is to come back to the hospital to have a health care professional
           remove the catheter for you. The pump, catheter and remaining fluid are disposable and
           will not hurt people or pets, so they will be thrown away. A physician will call you the
           night after the catheter comes out to ensure that you are comfortable.

        7. A research nurse will call you at 7 days and then 1, 2, 3, 6, and 12 months following
           your surgery. Each of these calls will be less than five minutes in length during which
           time you will be asked questions about your levels of pain, stiffness and joint
           functional ability. Your participation will be limited to 12 months after surgery with
           these phone calls.
    

Intervention name(s): Ambulatory continuous femoral nerve block for 100 hours
Intervention type(s): Procedure
Intervention description(s): Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee arthroplasty, postoperative analgesia; Primary, unilateral, total knee arthroplasty