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IRCT20230316057742N1 IRCT 2023-04-24 Babol University of Medical Sciences Effect of Dexamethasone on the severity of postoperative pain, sleep quality in patients after total knee arthroplasty Comparison of the effectiveness of high and low dose Dexamethasone intravenous injection on the severity of postoperative pain, sleep quality in patients after total knee arthroplasty 2023-03-21 anticipated 90 Complete https://irct.ir/trial/69228 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be selected by available sampling method and then will be randomly divided into one of three groups (A: 4mg Dexamethasone), (B: 8mg Dexamethasone) and (C: 16mg Dexamethasone). For random allocation, the method of permutated block randomization consisting of letters A, B and C is used in blocks of six. The process of random assignment will be such that first all six permutations of letters A, B and C (two of each letter) are written on separate sheets and thrown into a container. Randomly, we take out one of the sheets from the container and write down the composition written on it and return it to the container. According to the sample size in this study (90 people), this process is repeated and the extracted composition is recorded each time. Then, each letter is assigned a number from 1 to 90 in the order of the written letters, and each letter is placed in a separate envelope, and the number associated with the letter is noted on each envelope, Blinding description: The patient will not know about his treatment group. The researcher does not know the type of intervention allocated. It should be noted that the care personnel present in the department also do not have information about the allocation of patients in groups and the results of the intervention. The information related to the treatment groups is also not obvious to the biostatistician and the groups will be used only with the letters A, B and C for the analysis. 3 Total knee arthroplasty. Intervention 1: Control group: Patients of this group receive a dose of 4 mg of intravenous dexamethasone during surgery. Intervention 2: First Intervention group: Patients of this group receive a dose of 8 mg of intravenous dexamethasone during surgery. Intervention 3: Second Intervention group:. 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 Still undecided - no release schedule yet
public Majid Khalilizad
Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St , Babol
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 2071 m.khalilzad@mubabol.ac.ir Babol University of Medical Sciences scientific Majid Khalilizad
Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St ,
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 2071 m.khalilzad@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Age : 18 years and above 18 years no limit Both Any history of diabetes and taking antidiabetic medicines Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Patients of this group receive a dose of 4 mg of intravenous dexamethasone during surgery First Intervention group: Patients of this group receive a dose of 8 mg of intravenous dexamethasone during surgery Second Intervention group: Pain intensity score based on visual analogue scale, Sleep quality score based on Saint Mary's questionnaire. Timepoint: The sleep quality questionnaire is completed once the day before the operation and once again two weeks after the surgery, The intensity of pain is measured once the day before the operation and then after the end of the spinal anesthesia every four hours until 48 hours after the surgery based on the Visual Analogue Scale. Method of measurement: Sleep quality based on Saint Mary's questionnaire, Pain intensity based on Visual Analogue Scale. Babol University of Medical Sciences Approved 2023-03-12 Ethics committee of Babol University of Medical Sciences Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St , Babol Babol Mazandaran Iran (Islamic Republic of)