CRPS Clinical Trial
— PregTKAOfficial title:
A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
Verified date | July 2012 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
Status | Completed |
Enrollment | 240 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. History of osteoarthritis 2. Subjects who can understand and communicate in English. Exclusion Criteria: 1. Younger than 21 years or older than 80 years. 2. American Society of Anesthesiologists physical status IV. 3. Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion; however, patients will have been withdrawn from these medications for at least 7 days before surgery. 4. Patients with a history of neuropathic pain conditions. 5. Patients who are currently enrolled in another investigational study. 6. Pre-existing heart conditions 7. Patients on thiazolidinedione class of anti-diabetic medications (eg. rosiglitazone, pioglitazone). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Rush University Medical Center | Pfizer |
Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epidural Medication Consumption Rate | Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use. | 36 h | Yes |
Secondary | Neuropathic Pain (S-LANSS > 12) | Patients will be evaluated in blinded fashion for lower extremity CRPS at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an S-LANSS score of 12 or more at 6 mo came to the physician's office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation. | 3 and 6 months post-surgery | Yes |
Secondary | Knee Range of Motion (Active Flexion) | 1-30 days | No |
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