Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA), Post-Surgical Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 80
Updated:11/3/2018
Start Date:May 2007
End Date:December 2008

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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
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Little Rock, Arkansas 72205
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Allentown, Pennsylvania 18102
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Dallas, Texas 75204
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Egg Harbor Township, New Jersey 08234
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Galesburg, Illinois 61401
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Houston, Texas 77030
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King Of Prussia, Pennsylvania 19406
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New Iberia, Louisiana 70563
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New York, New York 10029
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Northport, Alabama 35476
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Philadelphia, Pennsylvania 19134
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Pittsburgh, Pennsylvania 15212
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Pomona, New Jersey 08205
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Tuscaloosa, Alabama 35406
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Upper Arlington, Ohio 43220
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Vero Beach, Florida 32960
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