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IRCT20160430027677N16 IRCT 2019-07-13 Oroumia University of Medical Sciences Evaluation the effects of Bupivacaine and dexmedetomidine on postoperative functional and pain Comparison of the effects of Bupivacaine and dexmedetomidine with Bupivacaine local injection alone on postoperative functional and pain in patient under shoulder rotator cuff repair with general anesthesia 2019-01-21 anticipated 60 Complete https://irct.ir/trial/39681 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into two groups of Dexmedetomidine and Bupivacaine (group D) and Bupivacaine (group B) using Random Allocation Software 2.0, and the target codes will be written and placed in sealed envelopes with sequential allocation using double-blind method, Blinding description: The anesthesiologist will be unaware of which patient will be assigned to which group. Syringes will be identical and only the operating room nurse will knew about the contents of each of them, and finally, after collecting information from the anesthesia residents, the anesthesiologist will be informed of the group each patient will be assigned to. 2-3 pain. Intervention 1: Intervention group: topical injection bupivacaine 0.1 % ( diluted with normal saline 10 cc) plus dexmedetomidine 1 microgram per kg body in site of surgery. Intervention 2: Control group: topical injection bupivacaine 0.1 % ( diluted with normal saline 10 cc) in site of 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
public Shahryar Sane
Emergrnt Street, Resalat Blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences scientific Shahryar Sane
Emergrnt Street, Resalat Boulevard
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) aged 20 to 70 years American Society of Anesthesiologists physical status classification I and II Absence of extensive damage to the rotator cuff 20 years 70 years Both History of allergy to used drugs The history of drug addiction Known coagulation disorders History of renal disease History of liver disease Body mass index more than 35 kg/m2 R52.9 Generalized pain NOS Prevention Prevention Intervention group: topical injection bupivacaine 0.1 % ( diluted with normal saline 10 cc) plus dexmedetomidine 1 microgram per kg body in site of surgery Control group: topical injection bupivacaine 0.1 % ( diluted with normal saline 10 cc) in site of surgery Pain. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Function. Timepoint: On the day before surgery and on postoperative day. Method of measurement: QoR-40 scoring system. Mean Arterial Blood Pressure. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: None Invasive Blood Pressure. Mean pulse Rate. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Electrocardiogram. Sleep disturbance. Timepoint: Until 24 hours after surgery. Method of measurement: Ten point scale. Oroumia University of Medical Sciences Approved 2018-12-26 Ethics commitee of Urmia University of Medical Sciences Emergent Street, Ershad Avenue Urmia West Azarbaijan Iran (Islamic Republic of)