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IRCT20120624010102N2 IRCT 2019-12-10 Tehran University of Medical Sciences effect of duloxetine on post operative pain Effect of Duloxetine administeration on postoperative pain after abdominal hysterectomy compared to the placebo 2020-01-20 anticipated 76 Complete https://irct.ir/trial/43514 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly allocated to 2 groups using balanced block randomization, Blinding description: The study medications are prepared by an anesthesiologist who does not otherwise participated in the study and then enveloped and sealed and patient's code are recorded on it.The enveloped will open 2 hours before induction by an anesthesiologist who is blinded to patient's study group and type of solution.All of the nurses and patient's are blinded to the type of solution and to the patient's study group allocation. N/A control of acute post operative pain. Intervention 1: Intervention group: Oral duloxetine capsule 60 mg (Kharazmi Pharmacy) 2 hours before surgery(SNRI). Intervention 2: Control group: Placebo 2 hours before surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information yet
public Fahime Zamiri
Karim Khan Street End of North Ostad Nejatolahi Street
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8899 5767 fahimezamiri139431@gmail.com Tehran University of Medical Sciences scientific Fahime Zamiri
Yas hospital,Karim khan zand street
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8899 5767 fahimezamiri139431@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Female age 35-65 Elective total abdominal hysterectomy ASA class 1 & 2 35 years 65 years Female patient refusal Any alergic history with Duloxetine or other SNRIs surgery longer than 3 hours Postoperative cancer diagnosis or any other pelvic pathology during the operation Need additional surgery Any other incision than Pfannenstiel Treatment - Drugs Treatment - Drugs Intervention group: Oral duloxetine capsule 60 mg (Kharazmi Pharmacy) 2 hours before surgery(SNRI) Control group: Placebo 2 hours before surgery Pain. Timepoint: 30 min ,1 , 2 , 6 ,12 hours after surgery. Method of measurement: VAS score. Nausea and vomiting. Timepoint: 0 to 12 hours postoperative. Method of measurement: Asking. Tehran University of Medical Sciences Approved 2018-07-23 Tehran University of Medical Sciences 5th flour, Corner of ghods St, Keshavarz Blv. Tehran Tehran Iran (Islamic Republic of)