Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA
Condition: CRPS
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment