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IRCT20210216050379N4 IRCT 2023-04-05 Shahid Beheshti University of Medical Sciences New technique of distal radius surgery Comparing the effectiveness of adding dexmedetomidine to standard Walant solution in local anesthesia of patients with distal radius fracture on postoperative complications. 2023-04-09 anticipated 40 Complete https://irct.ir/trial/67684 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization will be done by dividing included patients into some blocks of size 2n( 2,4,6,8 and...), then randomizing patients in each block will be done such that n patients are allocated to the experimental group and control group. then we will choose the blocks randomly. This method ensures equal treatment allocation within each block when the complete block is used. 3 Distal radius fracture. Intervention 1: Intervention group: For patients with distal radius fractures, Walant solution containing 20 ml of 2% lidocaine with 2 CC of 1000/01 epinephrine vial, 14 CC of normal saline and 4 CC of 8.4% sodium bicarbonate (40 CC in total) and the same solution in addition 50 micrograms per kilogram of their weight, dexmedetomidine is injected at the site of operationp:. Intervention 2: Control group: patients with distal radius fracture who received Walant solution with WALANT technique (full awake local anesthesia without using tourniquet) including 20 ml lidocaine 2% with 2 CC of epinephrine 01/1000 vial, with 14 CC of normal saline and 4 CC They receive 8.4% sodium bicarbonate (40 CC in total) at the surgical site. 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 It has not yet been decided by me and my colleagues
public Hamidreza Azizifarsani
NO.1,Shahid Lamee st, Faraze, Tehran
Tehran Iran (Islamic Republic of) 1981956316 +98 21 2238 2080 h.faresani@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamidreza Azizifarsani
No 1, Shahid Lamee st, Faraz,Tehran
Tehran Iran (Islamic Republic of) 1981956316 +98 21 2238 2080 h.faresan@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Distal radius fracture requiring surgery for fixation 18 years 80 years Both Active surgical site infection Peripheral vascular disease anxiety Impaired coagulation profile Phobia of injections S52.5 Fracture of lower end of radius Treatment - Surgery Placebo Intervention group: For patients with distal radius fractures, Walant solution containing 20 ml of 2% lidocaine with 2 CC of 1000/01 epinephrine vial, 14 CC of normal saline and 4 CC of 8.4% sodium bicarbonate (40 CC in total) and the same solution in addition 50 micrograms per kilogram of their weight, dexmedetomidine is injected at the site of operationp: Control group: patients with distal radius fracture who received Walant solution with WALANT technique (full awake local anesthesia without using tourniquet) including 20 ml lidocaine 2% with 2 CC of epinephrine 01/1000 vial, with 14 CC of normal saline and 4 CC They receive 8.4% sodium bicarbonate (40 CC in total) at the surgical site Pain. Timepoint: During and immediately after surgery. Method of measurement: Visual analogue scale. Hemodynamic status during surgery. Timepoint: During surgery. Method of measurement: Monitoring during surgery. Bleeding volume during surgery. Timepoint: during surgery. Method of measurement: Blood volume measurement. Shahid Beheshti University of Medical Sciences Approved 2022-07-24 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak street Tehran Tehran Iran (Islamic Republic of)