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Trial record 1 of 1 for:    NCT00558753
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Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA (PregTKA)

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ClinicalTrials.gov Identifier: NCT00558753
Recruitment Status : Completed
First Posted : November 15, 2007
Results First Posted : August 27, 2012
Last Update Posted : May 26, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE November 14, 2007
First Posted Date  ICMJE November 15, 2007
Results First Submitted Date  ICMJE January 11, 2012
Results First Posted Date  ICMJE August 27, 2012
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Epidural Medication Consumption Rate [ Time Frame: 36 h ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
During the immediate postoperative phase, the total epidural medication consumption will be recorded for each 4 hour interval over this study period of 36 hours. [ Time Frame: 36 h ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
  • Neuropathic Pain (S-LANSS > 12) [ Time Frame: 3 and 6 months post-surgery ]
    Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(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 Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(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.
  • Knee Range of Motion (Active Flexion) [ Time Frame: 1-30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
  • 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. [ Time Frame: 6 months post-surgery ]
  • The degree of active and passive knee flexion and the number of days required until obtaining 90º of active knee flexion will be recorded by the physical therapist twice daily until discharged from the hospital. [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA
Official Title  ICMJE A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
Brief Summary 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.
Detailed Description

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.

Gabapentin and the related more potent compound pregabalin have been shown to reduce postoperative pain in animal models. Pregabalin also reduces neuropathic pain in rats. In patients, gabapentin has been administered before surgery to treat postoperative pain. In addition, pregabalin has been given postoperatively to reduce dental pain after molar extraction. Gabapentin has been used for many years in patients with neuropathic pain, including reflex sympathetic dystrophy. More recently, pregabalin has also been shown to be efficacious in the treatment of neuropathic pain. However, no clinical study has investigated whether perioperative administration of gabapentin or pregabalin can reduce persistent long-term pain syndromes e.g. CRPS.Subjects between the ages of 21 and 80 will be recruited after obtaining an Informed Consent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE CRPS
Intervention  ICMJE
  • Drug: pregabalin
    PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
    Other Name: Lyrica
  • Drug: Placebo
    Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
Study Arms  ICMJE
  • Placebo Comparator: 1 Placebo
    Half of the patients will receive PO placebo for 14 days
    Intervention: Drug: Placebo
  • Experimental: 2 Pregabalin
    PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
    Intervention: Drug: pregabalin
Publications * 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.0b013e3181c4273a. Epub 2009 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2010)
240
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2007)
300
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00558753
Other Study ID Numbers  ICMJE ABuv102007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asokumar Buvanendran, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Asokumar Buvanendran, M.D. Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP