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
  Purpose

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.


Condition Intervention Phase
Primary Total Knee Arthroplasty
Drug: Pregabalin 50mg
Drug: Pregabalin 100mg
Drug: Pregabalin 150mg
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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?


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Patients will receive 0mg of pregabalin
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.
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.
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
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333956

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Jacques T YaDeau, M.D., Ph.D. Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01333956     History of Changes
Other Study ID Numbers: 11043
Study First Received: April 8, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014