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IRCT20200622047874N2 IRCT 2021-03-02 Esfahan University of Medical Sciences Comparison the effect of hematoma block with injection of Lidocaine versus hematoma block with injection of Lidocaine plus ketamine on reduction of pain in patients with distal radius fracture Comparison the effect of hematoma block with injection of Lidocaine versus hematoma block with injection of Lidocaine plus ketamine on reduction of pain in patients with distal radius fracture 2021-08-23 anticipated 60 Complete https://irct.ir/trial/51956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation is performed using random allocation software (RAS). In this software, the total sample size and number of groups are entered into the software. The software output includes a list that distributes the total sample size by number between the two groups. Patients are distributed in two groups according to the list and in order of referral time to complete the sample size in both groups, Blinding description: The study is a double-blind study and patients and researchers are unaware of the type of drug injected to patients. The drugs are prepared and coded by one of the operating room staff in a syringe and given to the researcher for injection. 2-3 radius fracture. Intervention 1: intervention group 1: In this group, block hematoma is performed by injecting 8 ml of 2% lidocaine. Intervention 2: Intervention group 2: In this group, block hematoma is performed by injecting 8 ml of 2% lidocaine with 0.5 mg kg of ketamine. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan belongs to the government organization and it is not possible to share it
public Dr. Azardokht Rahimi Nik
Isfahan University of Medical Sciences, Hezar Jareeb St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 2020 azinik11@gmail.com Esfahan University of Medical Sciences scientific Dr. Azardokht Rahimi Nik
Isfahan University of Medical Sciences, Hezar Jareeb St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 2020 azinik11@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Distal radius fracture that requires reduction by a physician Age over 18 years old Satisfaction to enter the study Absence of trauma in other areas of the body, especially the patient's head Absence of bone abnormalities and previous fractures at the site of the radius bone Hypersensitivity to lidocaine and ketamine 18 years no limit Both Drug and alcohol addiction Having coagulation diseases Psychiatric disorders Liver disorders Epilepsy Hypertension and heart rate less than 55 Patient dissatisfaction to continue the study S52. 5 radious fracture Treatment - Drugs Treatment - Drugs intervention group 1: In this group, block hematoma is performed by injecting 8 ml of 2% lidocaine. Intervention group 2: In this group, block hematoma is performed by injecting 8 ml of 2% lidocaine with 0.5 mg kg of ketamine. Patients' pain score during manipulation (reduction). Timepoint: At the time of fracture placement and 1 and 6 hours later. Method of measurement: Visual analog scale (VAS) that divides pain intensity from zero to ten. Patient satisfaction. Timepoint: In the 6 hour after fracture placement. Method of measurement: Likert criteria for satisfaction, completely satisfied, satisfied, dissatisfied, dissatisfied and completely dissatisfied. Esfahan University of Medical Sciences Approved 2018-06-21 Isfahan University of Medical Sciences Hezar Jareeb Isfahan Isfehan Iran (Islamic Republic of)