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IRCT20141209020258N158 IRCT 2021-05-11 Arak University of Medical Sciences Comparison of onset, duration and quality of supraclavicular block using 0.5% bupivacaine with magnesium sulphate , ketamine and neostigmine in forearm orthopedic surgery Comparison of onset, duration and quality of supraclavicular block using 0.5% bupivacaine with magnesium sulphate , ketamine and neostigmine in forearm orthopedic surgery 2021-05-22 anticipated 90 Complete https://irct.ir/trial/56155 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random allocation with envelopes in 3 groups A and B and C. In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. 3 Forearm orthopedic surgery. Intervention 1: ntervention group 1: 25 milliliter of 0.5% bupivacaine with 100 milligram of magnesium sulfate (1 millilite of 10% solution) is prescribed. (Bupivacaine by Strazenka UK-Magnesium Sulfate by Shahid Ghazi Co in Tabriz). Intervention 2: Intervention group 2: 25millilite of bupivacaine 0.5% with 2 milligram in kilogram of ketamine is prescribed. (Ketamine made by Rotex Medica - Germany). Intervention 3: Intervention group 3:25 millilite of 0.5% bupivacaine with 500 micrograms of neostigmine is prescribed. (Neostigmine ampoule made by Caspian Tamin Co - Rasht). 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 There is no more information
public dr Bijan Yazdi
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 yazdi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 20 -70 years Candidate for upper limb orthopedic surgery No more than one fracture in the body or surgery No blood coagulation diseases and disorders in PTT, PT and INR Body mass index less than 35 Lack of psychological problems No pregnant Absence of neurological disorders in the hand No allergies to drugs used Absence of chronic pain syndrome 20 years 70 years Both Lack of patient cooperation to perform the block Block failure Surgery time less than 50 and more than 150 minutes Need for more sedation than stated in the plan S52.9 Unspecified fracture of forearm Treatment - Drugs Treatment - Drugs Treatment - Drugs ntervention group 1: 25 milliliter of 0.5% bupivacaine with 100 milligram of magnesium sulfate (1 millilite of 10% solution) is prescribed. (Bupivacaine by Strazenka UK-Magnesium Sulfate by Shahid Ghazi Co in Tabriz) Intervention group 2: 25millilite of bupivacaine 0.5% with 2 milligram in kilogram of ketamine is prescribed. (Ketamine made by Rotex Medica - Germany) Intervention group 3:25 millilite of 0.5% bupivacaine with 500 micrograms of neostigmine is prescribed. (Neostigmine ampoule made by Caspian Tamin Co - Rasht) Pain. Timepoint: In recovery and 2 ,4, 8, 12 and 24 hours after surgery. Method of measurement: Visual analog scale of pain. Narcotics consumption. Timepoint: 24 hours after surgery. Method of measurement: Observation. Sensory block. Timepoint: Every 1 minute. Method of measurement: chronometer. Motor block. Timepoint: Every 5 minute. Method of measurement: chronometer. Arak University of Medical Sciences Approved 2021-04-21 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)