postoperative pain and analgesic consumption between the first and the second surgery would
be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).
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Full eligibility criteria for NCT01457313
Ages eligible for Study
up to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
patients undergoing elective bilateral staged total knee arthroplasty at a 1-week interval under spinal anesthesia,
American Society of Anesthesiologists physical status of I to II
any contraindication to spinal anesthesia or femoral nerve block such as coagulopathy; conversion to general anesthesia; preexisting pain syndrome; abnormal liver function or renal test results; severe heart, liver, or renal disease; history of stroke or neurologic deficits; psychiatric disorder; chronic opioid use; drug dependency; allergy to study medications; inflammatory joint disease; previous surgery on or trauma of the knee; difference in preoperative VAS score of ≥ 20 (at rest and at maximum knee flexion) between each side of the knee; body mass index of ≥ 40 kg/m2; and inability to comprehend the VAS or to use patient-controlled analgesia (PCA.
Tris trial is registered with FDA with number: NCT01457313. The sponsor of the trial is Seoul National University Bundang Hospital and it is looking for 34 volunteers for the current phase.
Official trial title: Comparison of Postoperative Pain in the First and Second Knee in Staged Bilateral Total Knee Arthroplasty: Clinical Evidence That Central Sensitization Increases Systemic Pain Sensitivity
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