Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Condition(s) targeted: Osteoarthritis; Postoperative Pain

Intervention: pregabalin (Drug); pregabalin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: 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)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess the efficacy of pregabalin compared to placebo on pain following total knee arthroplasty using a subject reported assessment of worst pain.

Secondary outcome:

Effect of pregabalin on the occurrence of opioid related symptoms

To evaluate the presence of neuropathic pain symptoms at 3 and 6 months post surgery

Effect of pregabalin on rescue medication/opioid sparing

Evaluate the effect of pregabalin at reducing post-operative pain at different time points post total knee arthroplasty

To evaluate the effect of pregabalin on time to eligibility for hospital discharge and time to actual hospital discharge

Evaluate the effect of pregabalin on pain interference with functional activities

Evaluate safety and tolerability of pregabalin

To evaluate the effect of pregabalin on persistent post-operative pain

To evaluate the effect of pregabalin on pain-related sleep interference

To evaluate the effect of pregabalin on treatment satisfaction with study medication

To evaluate the effect of pregabalin on pre-operative anxiety

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with osteoarthritis (OA) undergoing elective total knee arthroplasty (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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Northport, Alabama 35476, United States; Recruiting

Pfizer Investigational Site, Tuscaloosa, Alabama 35401, United States; Recruiting

Pfizer Investigational Site, Tuscaloosa, Alabama 35406, United States; Recruiting

Pfizer Investigational Site, Birmingham, Alabama 35205, United States; Not yet recruiting

Pfizer Investigational Site, Birmingham, Alabama 35209, United States; Not yet recruiting

Pfizer Investigational Site, Phoenix, Arizona 85023, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 331036, United States; Recruiting

Pfizer Investigational Site, Vero Beach, Florida 32960, United States; Recruiting

Pfizer Investigational Site, Chicago, Illinois 60612, United States; Recruiting

Pfizer Investigational Site, Galesburg, Illinois 61401, United States; Recruiting

Pfizer Investigational Site, Lafayette, Louisiana 70503, United States; Recruiting

Pfizer Investigational Site, New Iberia, Louisiana 70563, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21218, United States; Recruiting

Pfizer Investigational Site, Voorhees, New Jersey 08043, United States; Recruiting

Pfizer Investigational Site, Egg Harbor Township, New Jersey 08234, United States; Recruiting

Pfizer Investigational Site, Pomona, New Jersey 08205, United States; Recruiting

Pfizer Investigational Site, Englewood, New Jersey 07631, United States; Recruiting

Pfizer Investigational Site, New York, New York 10021, United States; Recruiting

Pfizer Investigational Site, New York, New York 10021, United States; Not yet recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28207, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43214, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43215, United States; Recruiting

Pfizer Investigational Site, Upper Arlington, Ohio 43220, United States; Recruiting

Pfizer Investigational Site, Allentown, Pennsylvania 18103, United States; Recruiting

Pfizer Investigational Site, Pittsburg, Pennsylvania 15232, United States; Active, not recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213-2582, United States; Active, not recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15232, United States; Active, not recruiting

Pfizer Investigational Site, King of Prussia, Pennsylvania 19406, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75390, United States; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Ending date: February 2009
Last updated: October 30, 2008