CRPS Clinical Trial
Official title:
A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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