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IRCT20160430027677N15 IRCT 2019-05-28 Oroumia University of Medical Sciences Evaluation the effect of dexmedetomidine with bupivacaine on postoperative pain Evaluation the effect of dexmedetomidine with bupivacaine and bupivacaine alone on postoperative pain in upper limb ortopedice surgery with supraclavicular block 2019-06-22 anticipated 60 Complete https://irct.ir/trial/39463 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not 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: Patients in Group dexmedetomidine will be received 39 ml of bupivacaine 0.25% with 1 ml (1 µg/kg) dexmedetomidine. Intervention 2: Control group: Patients in Group bupivacaine will be received 39 ml of bupivacaine 0.25% with 1 ml saline 0.9%. 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 20-60 years old American Society of Anesthesiologists physical status classification I General anesthesia 20 years 60 years Both History of cardiovascular disease History of respiratory disease History of renal disease History of liver disease Pregnancy Allergy to the drugs studied Contraindication of supraclavicular block Coagulopathy R52.9 Generalized pain NOS Prevention Placebo Intervention group: Patients in Group dexmedetomidine will be received 39 ml of bupivacaine 0.25% with 1 ml (1 µg/kg) dexmedetomidine Control group: Patients in Group bupivacaine will be received 39 ml of bupivacaine 0.25% with 1 ml saline 0.9% Pain. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Duration of the sensory block. Timepoint: From the onset of the sensory block until the onset of the first pain after surgery. Method of measurement: Pinprick. Duration of the motor block. Timepoint: Since full paralysis of limb until complete restoration of limb movement. Method of measurement: Bromage scale. Mean Arterial Blood Pressure. Timepoint: During surgery. Method of measurement: None Invasive Blood Pressure. Mean pulse Rate. Timepoint: During surgery. Method of measurement: Electrocardiogram. Pentazocine consumption. Timepoint: After transferring the patient to the ward in the first 24 hours. Method of measurement: milligram. Ormia University of Medical Sciences Approved 2018-09-05 Ethics commitee of Urmia University of Medical Sciences Emergent Street, Ershad Avenue Urmia West Azarbaijan Iran (Islamic Republic of)