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IRCT20120922010900N5 IRCT 2018-02-13 Kerman University of Medical Sciences Assessment of duloxetine effect on post-operative pain and recovery in patients who undergo abdominal hysterectomy under general anesthesia Assessment of duloxetine effect on post-operative pain and recovery in patients who undergo abdominal hysterectomy under general anesthesia 2018-02-20 anticipated 70 Complete https://irct.ir/trial/29299 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: the simple randomization is used to dividing the patients in 2 groups by means of table of random numbers, Blinding description: two hours before surgery, oral capsule of duloxetine is given to patients in case group and placebo (similar capsule containing starch) in control group. so, anesthesiologist, the patient and data collector are unaware of the kind of used drug. 2-3 postoperative pain. Intervention 1: Intervention group: two hours prior to surgery, patients in this group receive 60 mg oral capsule of duloxetine; brand name of Loxeta, made by Abidi pharmaceutical company. Intervention 2: Control group: in this group, patients receive placebo. Yes - There is a plan to make this available What will be shared: postoperative pain patient satisfaction of recovery When: data will be available just after publication in journal. To whom: data will be available for people working in academic institutions. Conditions: they can repeat statistical analysis. Where to obtain: contact via email address of responsible person How to obtain: after confirming identity of requested person. Comments:
public Fariba Mansoorinassab
Afzalipoor Hospital, Zendan Square
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3223 5011 javakrd34@gmail.com Kerman University of Medical Sciences scientific Hosein Sattari
Afzalipoor Hospital, Imamkhomeiny Highway
Kerman Iran (Islamic Republic of) 7616913911 +98 34 1322 2250 sattari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) All patients admitted to Afzalipoor Hospital for hysterectomy surgery ASA classification of I (without systemic disease) and II (with controlled systemic disease) informed consent of patient for participation 18 years 85 years Female long term usage of opioids steroid thrapy age less than 18 and more than 85 year pregnancy heart, hepatic and renal failure uncontrolled hypertension endocrine diseases BMI greater than 40 heart rate less than 50 evidence of heart block in ECG presence of suizure, epilepsy and bipolar disorders surgery lasting more than 3 hours huge bleeding during surgery G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group: two hours prior to surgery, patients in this group receive 60 mg oral capsule of duloxetine; brand name of Loxeta, made by Abidi pharmaceutical company. Control group: in this group, patients receive placebo. Postoperative pain. Timepoint: The level of pain is measured and documented every 15 minutes after patient reorientation, until discharge from recovery room. Method of measurement: Visual Analogue Scale (VAS) is used for pain assessment. Patient satisfaction. Timepoint: 24 hours after surgery. Method of measurement: postoperative quality of recovery (QOR) score. Vital signs. Timepoint: every 15 minutes. Method of measurement: authomathic monitoring system. Kerman University of Medical Sciences Approved 2017-12-18 Ethics committee of Kerman University of Medical sciences Jomhoori boulevard Kerman Kerman Iran (Islamic Republic of)