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

Comparison the effectiveness of high and low dose Dexamethasone intravenous injection on the severity of postoperative pain, sleep quality in patients after total knee arthroplasty

A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 90 patients. Permuted block randomization method with block size 6 was used for randomization.

The day before the surgery, by referring to the department of the Shahid Beheshti hospital of Babol samples will be selected and a questionnaire sleep quality and pain level questionnaire will be completed. Patients will be randomly divided into one of three groups A,B&C. This process will be done by the ward personnel and the day before each patient's operation, so the patient will not know about his treatment group. It should be noted that the personnel in the department do not have information about the allocation of patients in groups. The information related to the treatment groups is also not obvious to the biostatistician. On the day of surgery, the anesthesiologist will give 4 mg of Dexamethasone in the control group(A), 16 mg of Dexamethasone in the high-dose Dexamethasone group(B), and 8 mg of Dexamethasone in the low-dose Dexamethasone group(C). After the spinal anesthesia is off, the pain level of the patient is measured every four hours until 48 hours after the surgery based on VAS. The sleep quality questionnaire is completed again two weeks after surgery.

The entry criteria is over 18 years of age and the non-entry criteria is a history of diabetes.

In the control group, 4 mg of intravenous Dexamethasone, in the high-dose Dexamethasone group, 16 mg of intravenous Dexamethasone, and in the low-dose Dexamethasone group, 8 mg of intravenous Dexamethasone will be given to the patients.

Pain level؛ Sleep quality

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.

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.