144
Participants
Start Date
December 1, 2013
Primary Completion Date
November 30, 2019
Study Completion Date
October 31, 2020
Perineural infusion [continuous peripheral nerve block(s)]
Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution.
Walter Reed Army National Medical Center, Bethesda
Cleveland Clinic, Cleveland
University of California, San Diego, Hillcrest Medical Center, San Diego
Veteran's Affairs Palo Alto Health Care System, Palo Alto
United States Department of Defense
FED
University of California, San Diego
OTHER