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IRCT20190719044276N1 IRCT 2020-02-20 Iran University of Medical Sciences The comparison of effect of pregabalin and duloxetine on post-op pain The comparison of peri-operative administration of pregabalin and duloxetine on post-op pain after TKA 2019-11-22 anticipated 90 Complete https://irct.ir/trial/42807 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, with convenience method, we collect the numbers of calculated sample of intended patients. Then based on their numbers, we write A, B, C and patients choose from them, Blinding description: In this research, the person who gives medications to patients and evaluates the effects of medications, doesn't know the type of medication. 3 Post-op pain; Total Knee Arthroplasty surgery. Intervention 1: First intervention group: the patients who receive a 75 milligram pregabalin tablet 1.5 hours before surgery and 12 and 24 hours after TKA. Intervention 2: Second intervention group: the patients who receive a 30 milligram duloxetine tablet 1.5 hours before surgery and 12 and 24 hours after TKA. Intervention 3: Control group: the patients who receive a placebo 1.5 hours before surgery and 12 and 24 hours after TKA. Yes - There is a plan to make this available What will be shared: All data can be shared. When: The start of achieving is 6 months after the publishing of results To whom: Researchers and all people who work in universities and industries Conditions: Usage of data for doing larger research is permissible. Where to obtain: E-mail address: farimani@iums.ac.ir How to obtain: E-mail the request from creditable university or company Comments:
public Farnad Imani
Pain research center, Rasul-e Akram hospital, Mansouri Ave., Niyayesh St., Sattar-khan St.,Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6651 5758 farimani@iums.ac.ir Iran University of Medical Sciences scientific Farnad Imani
Pain research center, Rasul-e Akram hospital, Mansouri Ave., Niyayesh St., Sattar-khan St.,Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 5758 farimani@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients have TKA (total knee arthroplasty) surgery Patients have spinal anesthesia Patients are ASA I-II 40 years 75 years Both Patients don't have consent Patients with allergy history of pregabalin and duloxetine Lower limbs neuropathy Drug abuse Therapy with pregabalin or deluxetine Any diseases that hinder patients to cooperate in this research G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Placebo First intervention group: the patients who receive a 75 milligram pregabalin tablet 1.5 hours before surgery and 12 and 24 hours after TKA. Second intervention group: the patients who receive a 30 milligram duloxetine tablet 1.5 hours before surgery and 12 and 24 hours after TKA. Control group: the patients who receive a placebo 1.5 hours before surgery and 12 and 24 hours after TKA. The pain score after total knee arthroplasty surgery. Timepoint: 1,12,24,48 hours after surgery. Method of measurement: Visual Analogue Scale. Iran University of Medical Sciences Approved 2019-12-03 Ethics committee of Iran university of medical sciences Iran university of medical sciences, Shahid Hemat highway,Tehran Tehran Tehran Iran (Islamic Republic of)