]>
IRCT20140129016415N9 IRCT 2022-06-26 Esfahan University of Medical Sciences Evaluation of effects of adding Dexmedetomidine, Dexamethasone and Na Bicarbonate to Ropivacaine in ultrasound-guided supraclavicular block Comparative evaluation of effects of adding Dexmedetomidine, Dexamethasone and Na Bicarbonate to Ropivacaine in ultrasound-guided supraclavicular block on the quality of the block in orthopedic surgery 2022-06-05 anticipated 120 Complete https://irct.ir/trial/63769 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are placed in one of four experimental groups using a table of random numbers. The default movement in the table from right to left and from bottom to top is considered and the numbers 0 to 29 in group 1 and the numbers 30 to 59 in group 2 and the numbers 60 to 89 in group 3 and the numbers 90 to 119 They are in group 4. The starting point of the movement in the table is determined randomly by the first client by placing a finger with his eyes closed on the table, Blinding description: The project partner prepared the drug used to perform supraclavicular block by adding additive (dexmedetomidine, sodium bicarbonate, dexamethasone, or normal saline) to ropivacaine in similar syringes and in the same final volume and after coding (1 to 4) It is provided to the executor, the executor (drug injector and data collector) and the patient are not aware of the type of drug added to the injectable ropivacaine and the codes will be opened after sampling and statistical analysis are completed. 3 upper limb surgery. Intervention 1: First intervention group: 30 micrograms of dexmedetomidine in 1 ml of normal saline is added to the 30 ml of ropivacaine used to block. Intervention 2: Second intervention group: 0.6 ml of 7.5% bicarbonate solution is increased to 1 ml with normal saline and then added to Block drug (30 CC ropivacaine). Intervention 3: Third intervention group: 4 mg (1 ml) of dexamethasone is added to the 30 ml of ropivacaine used to block. Intervention 4: Control group: 1 ml of normal saline is added to 30 ml of ropivacaine used to block. 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 Mohammad Golparvar
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8136656433 +98 31 3220 1750 golparvar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Golparvar
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8136656433 +98 31 3220 1750 golparvar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 years and older Weight (Lean body mass) between 50 to 90 kg ASA 1 and 2 Introduced for upper limb surgery (distal to the lower third of arm) 18 years no limit Both Local infection at the site of the block Existence of coagulation disorder or taking anticoagulants Hypersensitivity to dexmedetomidine, dexamethasone and ropivacaine Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo First intervention group: 30 micrograms of dexmedetomidine in 1 ml of normal saline is added to the 30 ml of ropivacaine used to block. Second intervention group: 0.6 ml of 7.5% bicarbonate solution is increased to 1 ml with normal saline and then added to Block drug (30 CC ropivacaine) Third intervention group: 4 mg (1 ml) of dexamethasone is added to the 30 ml of ropivacaine used to block. Control group: 1 ml of normal saline is added to 30 ml of ropivacaine used to block. The interval between the injection of the drug and the onset of anesthesia and immobility. Timepoint: Every 3 minutes. Method of measurement: Evaluation of the movement block is done using 2 movement examinations: 1- Asking the patient to place the index and middle fingers against each other while the other fingers are in the extension position 2- Maintaining the forearm position in a 90 degree position with the arm in a position The performer places the patient's arm perpendicular to the patient's body. The sensory block is evaluated by pressing the Blunted needle on the three points of the dorsal hand, forearm and arm. Duration of sensory and motor block. Timepoint: Every 15 minutes. Method of measurement: Evaluation of the movement block is done using 2 movement examinations: 1- Asking the patient to place the index and middle fingers against each other while the other fingers are in the extension position 2- Maintaining the forearm position in a 90 degree position with the arm in a position The performer places the patient's arm perpendicular to the patient's body. The sensory block is evaluated by pressing the Blunted needle on the three points of the dorsal hand, forearm and arm. Esfahan University of Medical Sciences Approved 2022-04-12 Ethics committee of Isfahan University of Medical Sciences No.100, Jahan-nama valley, Babalrahmeh street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)