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IRCT20200627047934N1 IRCT 2020-07-07 Islamic Azad University Effects of Betamethasone In Total Knee Arthroplasty MCPI = Multimodal Cocktail Periarticular Injection TKA = Total Knee Arthroplasty Evaluating The Results Of Addition Of Betamethasone To Multimodal Cocktail Periarticular Injection In Bilateral Total Knee Arthroplasty 2018-12-05 anticipated 30 Complete https://irct.ir/trial/49265 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We divide patients by randomization with 4 blocks into groups A and B. Group A includes patients who are injected with a cocktail containing betamethasone in their right knee. In group B, a cocktail containing betamethasone is injected into the left knee. On the morning of the operation, the envelope containing the patient's group will be given to the surgeon, Blinding description: Patients, researchers, physiotherapists, and all nursing staff are unaware of these groupings (A and B) (and the study is double blind). Because the surgeon is unaware of the groupings, he will have no role in postoperative care. After collecting all the data, the information will be analyzed. 2-3 Bilateral osteoarthritis of knee. Intervention 1: We divide patients by randomization with 4 blocks into groups A and B. Group A includes patients who are injected with a cocktail containing betamethasone in their right leg. In group B, a cocktail containing betamethasone is injected into the left leg. On the morning of the operation, the envelope containing the patient's group will be given to the surgeon. Half an hour before the operation, all patients will be injected with 1 g of intravenous Tranexamic acid, and after the operation, 500 mg of BD Tranexamic acid capsules will be given for 5 days. All patients are given 1 g of intravenous cefazolin before surgery (2 g if they weigh more than 80 kg) and 1 g of Tds after surgery. General anesthesia will be used for all patients. All joint replacement procedures will be performed using the Medial Para-Petlar Surgery Technique.Method of classification and injection of cocktails: In the knee of the intervention, 500 mg/5 ml Tranexamic acid , 20 mg of Bupivacaine, 30 mg of Ketorolac and 6 mg of Betamethasone LA (Betamethasone acetate 3mg + Betamethasone 3 mg) are combined . The final volume of the cocktail will reach 45ml with normal saline and will be injected in two steps: The first injection is before the protheses are placed, during which 30ml of the cocktail is applied to all the surrounding tissues except the posterolateral capsule (to prevent temporary paralysis of Proneal nerve) will be performed. The next injection contains the remaining 15 ml of the cocktail, which will be applied to the edges of the wound when it closing. Antithrombotic treatment with 40 mg subcutaneous Enoxaparin is started the day after surgery. The tourniquet is used in all patients and the drain is going out 24 hours after the operation. drawing Bandage is used compressively. Patients will walk from the night of the operation and if they do not tolerate the day after the operation. For pain control in the first 48 hours, 5mg of morphine PRN is prescribed a maximum of 3 times, 1g of Apotel ampoules TDS and one Ketorolac ampoule BD. Pain control will be performed after 48 hours with 15 mg of Meloxicam daily and 1g of Acetaminophen 3 times a day. To compare the two cocktails, we will divide the knees into two groups A (in which a cocktail containing Betamethasone is injected) and B (in which a cocktail without Betamethasone is injected). Intervention 2: Control Knee: In this group, betamethasone-free injectable cocktail (500 ml / mg 5 mg tracenamic acid, 20 mg bupivacaine, 30 mg ketorolac) is made. The final volume of the cocktail with normal saline will reach 45ml. The rest of the steps will be similar to the intervention knee. 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 Farivar Bagheri
Khatam al Anbya Hospital, Daneshgah Blvd.
Shahroud Iran (Islamic Republic of) 3614871151 +98 23 3239 2661 Dr.mamad73@gmail.com Islamic Azad University scientific Farivar Bagheri
Khatam al Anbya Hospital, Daneshgah Blvd.
Shahroud Iran (Islamic Republic of) 3614871151 +98 912 714 0282 Dr.mamad73@gmail.com Islamic Azad University Iran (Islamic Republic of) People aged 50 to 90 years Having advanced osteoarthritis of both knees 50 years 90 years Both People who did not agree to study and use their information Contraindications to the use of the studied drugs (including known allergies or intolerance to one of the drugs, fungal infections, having heart, liver, brain, kidney disease and inflammatory diseases of the joints, people with bleeding disorders, gastrointestinal bleeding, Asthma, glaucoma, cataracts and diabetic patients) Patients weighing more than 100 kg Patients with neuropathic pain and sensory disturbances in the foot Patients with a history of knee surgery M17.0 Bilateral primary osteoarthritis of knee Treatment - Drugs Treatment - Drugs We divide patients by randomization with 4 blocks into groups A and B. Group A includes patients who are injected with a cocktail containing betamethasone in their right leg. In group B, a cocktail containing betamethasone is injected into the left leg. On the morning of the operation, the envelope containing the patient's group will be given to the surgeon. Half an hour before the operation, all patients will be injected with 1 g of intravenous Tranexamic acid, and after the operation, 500 mg of BD Tranexamic acid capsules will be given for 5 days. All patients are given 1 g of intravenous cefazolin before surgery (2 g if they weigh more than 80 kg) and 1 g of Tds after surgery. General anesthesia will be used for all patients. All joint replacement procedures will be performed using the Medial Para-Petlar Surgery Technique.Method of classification and injection of cocktails: In the knee of the intervention, 500 mg/5 ml Tranexamic acid , 20 mg of Bupivacaine, 30 mg of Ketorolac and 6 mg of Betamethasone LA (Betamethasone acetate 3mg + Betamethasone 3 mg) are combined . The final volume of the cocktail will reach 45ml with normal saline and will be injected in two steps: The first injection is before the protheses are placed, during which 30ml of the cocktail is applied to all the surrounding tissues except the posterolateral capsule (to prevent temporary paralysis of Proneal nerve) will be performed. The next injection contains the remaining 15 ml of the cocktail, which will be applied to the edges of the wound when it closing. Antithrombotic treatment with 40 mg subcutaneous Enoxaparin is started the day after surgery. The tourniquet is used in all patients and the drain is going out 24 hours after the operation. drawing Bandage is used compressively. Patients will walk from the night of the operation and if they do not tolerate the day after the operation. For pain control in the first 48 hours, 5mg of morphine PRN is prescribed a maximum of 3 times, 1g of Apotel ampoules TDS and one Ketorolac ampoule BD. Pain control will be performed after 48 hours with 15 mg of Meloxicam daily and 1g of Acetaminophen 3 times a day. To compare the two cocktails, we will divide the knees into two groups A (in which a cocktail containing Betamethasone is injected) and B (in which a cocktail without Betamethasone is injected). Control Knee: In this group, betamethasone-free injectable cocktail (500 ml / mg 5 mg tracenamic acid, 20 mg bupivacaine, 30 mg ketorolac) is made. The final volume of the cocktail with normal saline will reach 45ml. The rest of the steps will be similar to the intervention knee. Pain score. Timepoint: It is measured at hours 6, 18, 24, 48 and on days 7, 14 and 60 after surgery. Method of measurement: Visual Analogue Scale. Knee range of motion. Timepoint: It will be measured at 24, 48 hours and 7 and 60 days after surgery. Method of measurement: Gonia meters. Oxford Knee Score. Timepoint: It will be checked before the operation and on the 60th day after the operation. Method of measurement: questionnaire. Wound complications. Timepoint: At any time of the visit. Method of measurement: Observation and examination. Patients' satisfaction with pain control. Timepoint: It will be asked at hours 24, 48 and on days 7 and 60 after the operation. Method of measurement: questionnaire. Islamic Azad University Approved 2019-03-09 Ethics Committee of Islamic Azad University - Shahroud Branch Central building, Islamic Azad University, next to the gas station, Daneshgah Blvd., Shahroud, Semnan Shahroud Semnan Iran (Islamic Republic of)