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Do You Have Phantom Limb Pain?

If so, you might be eligible for a research study that aims to decrease and/or resolve phantom limb pain in people with an upper or lower limb amputation.

The purpose of this research study is to determine if putting local anesthetic (numbing medication) through one or two tiny tube(s) placed next to the nerve(s) that go to an amputated limb will decrease and/or resolve phantom limb and stump pain. The procedure, device and infusion are all FDA approved and have been used for over 20 years to decrease pain immediately after surgery.

Participants will receive $100 following each catheter insertion plus $50/ day during the 6-day infusion(s), up to a maximum of $800/ subject.

This study is being conducted at the University of California (San Diego, California); Cleveland Clinic (Cleveland, Ohio); Walter Reed Army National Military Medical Center (Bethesda, Maryland); Palo Alto Veterans Affairs Medical Center (Palo Alto, California); and, Naval Medical Center (San Diego, California).

For more information, please call or email the UCSD coordinator:

 

(858) 242-6017        phantomlimbpainresearch@gmail.com

 

 

Study Intervention: To administer the local anesthetic to the nerves that go to an amputated limb, the skin is numbed and a small needle inserted to area around the nerves. Then, a small tube—called a “catheter” and smaller than a piece of spaghetti—is placed through the needle next to the nerves. The needle is removed leaving the catheter in place, and local anesthetic is then infused through the catheter to continuously bathe the nerves in numbing medication. The catheter cannot be felt once placed—there is no unpleasant feeling (or any feeling of the catheter at all). A small, portable infusion pump is used to infuse the local anesthetic so that patients may receive the treatment in the comfort of their own homes. The catheter may be removed at home as well, so that patients do not need to return to the hospital after the catheter is initially placed.

 

Study Protocol: One (arm/hand) or two (leg/foot) catheters will be placed. You will initially receive either local anesthetic or sterile saline (like water) through the catheter—determined randomly, like a flip of a coin. For the following week you will continue to go about your normal routine (although you should not drive), as the fluid will be infused using a small, portable infusion pump. You will be called daily so that we may check to see how you are doing.  After 6 days, the catheter will be removed and we will call you at home to see how you are doing. If you would like, 4-16 weeks after your original catheter(s) was placed, you may choose to repeat the above procedures, only this time receive the opposite study fluid. For example, if you received the sterile salt water during your first infusion, you would receive the local anesthetic during your second infusion. This option is provided regardless of whether or not you have any effect from the first infusion—it is completely up to you. In this way, every participant will have the opportunity to receive the experimental procedure within the first four months after enrolling. However, if you decide that you do not want the second infusion, there is no obligation to receive it.