]>
IRCT20200118046174N3 IRCT 2021-03-01 Tehran University of Medical Sciences The effect of prednisolone in patients with total hip arthroplasty Preoperative effects of single high dose prednisolone in patients with total hip arthroplasty 2020-09-10 anticipated 40 Complete https://irct.ir/trial/52568 observational Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization was done by "round list" software and with this software,patients will placed into control group or treatment group. Patients are randomly assigned to one of two groups,patient and doctor are not aware of patient selection that means neither doctor nor patients do not know about which patient will enter to study . Half of the patients are treated with methylprednisolone and the other half are treated with placebo. Patients in the methylprednisolone-treated group will receive IV 125 mg of methylprednisolone on the morning of surgery and patients in the control group receive 2 cc of isotonic saline injection. Patient anesthesia is total or general according to the anesthesiologist, Blinding description: for elimination of bias secendary to doctor or patients and result evaluator knowe, the type of treatment and its probable effect on the study result , the study done as double blind. according to that fact, the placebo and methylprednisolone are in same shaped box and are seald it is predictable that doctor and patient dont know which patient receive which type of drug. It is from both the doctor and the patient Patients are operated on by 4 assistants in year 3. Standard surgery is performed for all patients and before surgery 1 gr acetaminophen is injected for all patients and after surgery 1 gr acetaminophen is injected as BD and Pregabalin 75 mg as QHS for pain control. All patients receive prophylactic AB before surgery, and all patients receive cephalexin 500 mg TDS oral antibiotic for 7 days after surgery. After surgery for low molecular weight patients, heparin is injected for prophylaxis for 2 to 4 weeks for DVT prophylaxis. After 24-48 hours of surgery, if the general condition is good and proper, patients are discharged from the hospital and are visited at the clinic at intervals of 2 weeks, 6 weeks, 12 weeks and 24 weeks. In all patient visits, X-rays are performed in 2 directions and the graphs are checked by the senior orthopedic assistant in the direction of union. Patients are also examined at all times by an orthopedic assistant for R / O infection. The definition of union in radiography is the establishment of cortical continuity between two parts and the absence of pain is clinical. Multiple trauma patients with fractures in different areas, patients who are candidates for standard surgery. Patients with a history of renal, hepatic, gastric ulcer, pregnancy, lactating women, history of corticosteroids, patients under 18 years of age, patients taking corticosteroids or opioids, diabetic neuropathy and patients with heart failure, patients with poor control Diabetes mellitus (Poor control DM) As well as patients with poor blood pressure control (Poor control high blood pressure) They are excluded from the study. All diabetic patients admitted to the study undergo endocrine counseling to control blood sugar before and after surgery. In the text of the informed consent, the complications and benefits of entering the plan, and the methods of controlling possible complications, will be explained in a clear and understandable manner. The current standard procedure for patients undergoing arthroplasty is early initiation of the patient After surgery and the use of analgesics with intravenous acetaminophen to reduce pain, The use of physiotherapy is the currency of the operation to strengthen the abductors. 2-3 The effect of prednisolone on hip joint fractures leading to total hip arthroplasty. Intervention 1: the intervention group will receive 125mg intravenous methylprednisolone acetate as an anti-inflammatory agent 12 hours before surgery as a single dose. methylprednisolone is a moderately active glucocorticoid. there is high glucocorticoid activity with this drug (5times more than hydrocortisone) with no mineralocorticoid action. this is mostly be used as an immune suppressive and anti-inflammatory drug. liver metabolise this drug to sulfate and inactive glucocorticoid. inactive metabolites and some amounts of non-metabolised drug will have renal excretion. very low amounts of the drug will have fecal excretion. biological half life of the grug is 18 to 36 hours. Intervention 2: Control group: "Placebo recipients in the form of 2 cc intravenous normal saline serum is completely similar to the intervention group and single dose at the same time of hospitalization at the same time with the intervention group.Normal saline is a group of crystalloid solutions containing electrolytes in the form of 500 or 1000 cc serum. It is an electrolyte serum and contains sodium and chlorine.Nine grams per liter or 308 mOsm / L. 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 "There is no further information."
public Masoud Ghasemi
Tehran Sina Hospital Men orthopedic ward
tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ 23121297 Dr.masoud.ghasemi.ortho@gmail.com.com Tehran University of Medical Sciences scientific Syed Hossein shafeie
Tehran Sina Hospital Men orthopedic ward
tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ +98 21 6312 1297 Dr_hshafiei@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients who are candidate for primary hip arthroplasty all the patients with avascular necrosis of femoral head all the patients with femoral neck fracture who are candidate for primary hip arthroplasty all the patients with severe hip joint osteoarthritis who are candidate for primary hip arthroplasty 18 years no limit Both Multiple trauma patients with fractures in different areas, Patients who are not candidates for standard surgery. Patients with a history of renal failure, liver, gastric ulcer, pregnancy, lactating women, history of corticosteroids Patients under 18 years of age, patients taking corticosteroids or opioids, patients with diabetic neuropathy and patients with heart failure, patients with poor control of diabetes mellitus (Poor control DM) Also, patients with poor control of high blood pressure are excluded from the study. M87.0 Idiopathic aseptic necrosis of bone Treatment - Drugs Placebo the intervention group will receive 125mg intravenous methylprednisolone acetate as an anti-inflammatory agent 12 hours before surgery as a single dose. methylprednisolone is a moderately active glucocorticoid. there is high glucocorticoid activity with this drug (5times more than hydrocortisone) with no mineralocorticoid action. this is mostly be used as an immune suppressive and anti-inflammatory drug. liver metabolise this drug to sulfate and inactive glucocorticoid. inactive metabolites and some amounts of non-metabolised drug will have renal excretion. very low amounts of the drug will have fecal excretion. biological half life of the grug is 18 to 36 hours. Control group: "Placebo recipients in the form of 2 cc intravenous normal saline serum is completely similar to the intervention group and single dose at the same time of hospitalization at the same time with the intervention group.Normal saline is a group of crystalloid solutions containing electrolytes in the form of 500 or 1000 cc serum. It is an electrolyte serum and contains sodium and chlorine.Nine grams per liter or 308 mOsm / L. Patients after surgery underwent pain intensity assessment with a score of one to ten,Sleep quality assessments are completed by completing a psqi questionnaire, commissioning assessment, length of stay, and other demographic findings. Timepoint: At intervals of 2 weeks, 6 weeks, 12 weeks and 24 weeks. Method of measurement: In all patient visits, X-rays are performed in 2 directions and the graphs are checked by the senior orthopedic assistant. Patients are also examined at all times by an orthopedic assistant for R / O infection. Tehran University of Medical Sciences Approved 2020-06-28 Ethics Committee of Tehran University of Medical Sciences emam khomeni Tehran Tehran Iran (Islamic Republic of) Approved 2020-06-28 Ethics committee of tehran University of Medical Sciences Tehran Sina Hospital, Men's Orthopedic Department tehran Tehran Iran (Islamic Republic of)