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IRCT2017030132837N1 IRCT 2017-04-20 Vice chanceler for research, Iran university of medical sciences Comparison of the effect of Ketamine and Dexamethasone in combination with Lidocaine on the onset and duration of Axillary block in soft tissue surgery of forearm and hand Comparison of the effect of Ketamine and Dexamethasone in combination with Lidocaine on the onset and duration of Axillary block in soft tissue surgery of forearm and hand 2016-12-21 anticipated 78 Complete https://irct.ir/trial/25485 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Soft tissue injury of forearm and hand. Intervention 1: The intervention group 1 : Axillary block with 38 cc lidocaine 1% in combination with dexamethasone 8 mg in 2 ml. Intervention 2: The intervention group 2 : Axillary block with 38 cc Lidocaine 1% combination with 50 mg of Ketamine in 2 cc. Intervention 3: Control group : Axillary block with 38 cc lidocaine 1% in combination with 2 mL of saline.
public Dr Behrooz Zaman
23 St, Asad abadi St, Tehran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 0099 behroozzaman@gmail.com zaman.b@iums.ac.ir Hazrat Fatemeh Hospital scientific Dr Behrooz Zaman
23 St,Asad abadi St, Tehran
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 0099 behroozzaman@gmail.com zaman.b@iums.ac.ir Hazrat Fatemeh Hospital Iran (Islamic Republic of) Inclusion criteria: Consent to participate in research project and cooperation for axillary block; No addiction to opium, Benzodiazepine, Clonidine; Absence of liver and kidney failure, diabetes, cardiovascular and lung diseases, coagulopathy; Lack of any allergic history to local anesthetics; No use of opium in the past 48 hours; Absence of anatomical deformity or burning or infection in block region; No pregnancy in female patients. Exclusion criteria: The unwillingness or lack of cooperation from the patient during surgery. 20 years 50 years Both S50, S51, Superficial injury of forearm, Open wound of forearm, Injury of nerves at forearm level,Injury of blood vessels at forearm level, Injury of muscle and tendon at forearm level, Superficial injury of wrist and hand, Open wound of wrist and hand, Injury of Other Other Other The intervention group 1 : Axillary block with 38 cc lidocaine 1% in combination with dexamethasone 8 mg in 2 ml The intervention group 2 : Axillary block with 38 cc Lidocaine 1% combination with 50 mg of Ketamine in 2 cc Control group : Axillary block with 38 cc lidocaine 1% in combination with 2 mL of saline Onset of sensory block. Timepoint: every 3 minutes. Method of measurement: Measuring the length of time between the last injection until complete disappearance of any sense of touch with the stopwatch. Onset of motor block. Timepoint: every 3 minutes. Method of measurement: Measuring the length of time between the last injection to complete motor paralysis with Stopwatch. Duration of sensory block. Timepoint: every 3 minutes. Method of measurement: Measuring the time between onset of complete sensory block until the complete return again sense organs with Stopwatch. Duration of motor block. Timepoint: every 3 minutes. Method of measurement: Measuring the time between onset of complete paralysis to return of complete movement power with stopwtch. Diastolic blood pressure. Timepoint: 0, 5, 10, 15, 20, 25 minutes after Axillary block. Method of measurement: Non-invasive automatic sphygmomanometer. Systolic blood pressure. Timepoint: 0, 5, 10, 15, 20, 25 minutes after Axillary block. Method of measurement: Non-invasive automatic sphygmomanometer. Pulse rate. Timepoint: 0, 5, 10, 15, 20, 25 minutes after Axillary block. Method of measurement: ECG monitoring. Nystagmus. Timepoint: 0, 5, 10, 15, 20, 25 minutes after Axillary block. Method of measurement: Find the rapid movements of the eyes of horizontal reciprocating. Vice chanceler for research, Iran university of medical sciences Approved 2016-04-05 Iran University of Medical Sciences Ethics Committee Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Iran (Islamic Republic of)