Effects of Pregabalin on Pain After Total Knee Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01333956
First received: April 8, 2011
Last updated: May 1, 2013
Last verified: May 2013

April 8, 2011
May 1, 2013
May 2011
March 2013   (final data collection date for primary outcome measure)
Postoperative Pain [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: No ]
How much pregabalin is needed to reduce pain (occurring at rest and with activity) after total knee arthroplasty (TKA) at 2 weeks after surgery?
Postoperative Pain [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: No ]
How much pregabalin is needed to reduce pain (occurring at rest and with activity) after TKA at 2 weeks after surgery?
Complete list of historical versions of study NCT01333956 on ClinicalTrials.gov Archive Site
  • Opioid-Related Symptom Distress Score [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: No ]
    Opioid-Related Symptom Distress score (postoperative day [POD] 1, 2 weeks)
  • Self-assessed Sedation and Confusion [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
    Self-assessed sedation and confusion (POD1, POD3). Confusion Assessment Method (CAM score) (pre-operative and on POD1)
  • Numeric Rating Scale (NRS) and Neuropathic Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)
  • Opioid Usage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Opioid Usage (POD1, POD 3, 2 weeks, 3 months)
  • Orthopedic Outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Orthopedic outcomes (6 weeks and 3 months, at routine postoperative visits) as determined via the orthopedic knee society score and knee society score function tests. Data gathered will include range of motion (degrees), flexion contracture (degrees), contraction (degrees), alignment (degrees varus or valgus), pain while walking, number of blocks walked, use of walking aids, and ability to climb stairs.
  • Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)
  • Opioid-Related Symptom Distress Score [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: No ]
    Opioid-Related Symptom Distress score (POD1, 2 weeks)
  • Self-assessed sedation and confusion [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
    Self-assessed sedation and confusion (POD1, POD3). Confusion Assessment method (CAM score) (pre-operative and on POD1)
  • NRS and Neuropathic Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits) Neuropathic pain incidence: LANSS score (3 months)
  • Opioid Usage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Opioid Usage (POD1, POD 3, 2 weeks, 3 months)
  • Orthopedic Outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Orthopedic outcomes (6 weeks and 3 months, at routine postoperative visits) as determined via the orthopedic knee society score and knee society score function tests. Data gathered will include range of motion (degrees), flexion contracture(degrees), contraction (degrees), alignment(degrees varus or valgus), pain while walking, number of blocks walked, use of walking aids, and ability to climb stairs.
  • Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Satisfaction with pain management (2 weeks), is determined on a 1-10 scale (1=very dissatisfied, 10=very satisfied)
Not Provided
Not Provided
 
Effects of Pregabalin on Pain After Total Knee Arthroplasty
Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Total Knee Arthroplasty
  • Drug: Pregabalin 50mg
    Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
    Other Name: Lyrica
  • Drug: Pregabalin 100mg
    Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
    Other Name: Lyrica
  • Drug: Pregabalin 150mg
    Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
    Other Name: Lyrica
  • Drug: Placebo
    Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
  • Placebo Comparator: Control
    Patients will receive 0mg of pregabalin
    Intervention: Drug: Placebo
  • Experimental: 50mg Arm
    Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
    Intervention: Drug: Pregabalin 50mg
  • Experimental: 100mg Arm
    Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
    Intervention: Drug: Pregabalin 100mg
  • Experimental: 150mg Arm
    Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
    Intervention: Drug: Pregabalin 150mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
June 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
  • Age 18 to 80 years old
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
  • Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

  • Patients younger than 18 years old and older than 80
  • Patients intending to receive general anesthesia
  • Allergy or intolerance to one of the study medications
  • Patients with an ASA of IV
  • Patients with hepatic (liver) failure
  • Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])
  • Patients with difficult to manage diabetes mellitus, including insulin-dependence
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months)
  • Patients with major prior ipsilateral open knee surgery.
  • Chronic neurontin/lyrica use
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333956
11043
Not Provided
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Principal Investigator: Jacques T YaDeau, M.D., Ph.D. Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
May 2013

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