Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA)

Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.

Inclusion Criteria:

• Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
• Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
• The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3

Exclusion Criteria:

• Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
• Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
• Subjects with fibromyalgia and or other chronic pain syndromes