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IRCT20220413054520N1 IRCT 2022-05-23 Tehran University of Medical Sciences Effect of One-Month Oral Oxycodone on Postoperative Pain and Functional Recovery Following Total Knee Arthroplasty: A Randomized Clinical Trial Faroxy TKA Trial Evaluation of the effectiveness of oral prescription of Oxycodone in comparison with standard analgesic treatment on postoperative pain and final function after knee replacement surgery 2022-05-22 anticipated 190 Complete https://irct.ir/trial/62978 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized in a 1:1 ratio to receive either oxycodone or placebo. The study will be conducted in a triple-blind manner to ensure unbiased administration and assessment. Once a patient has been deemed eligible and has provided written informed consent, randomization will be performed using the Sealedenvelope.com platform. To maintain the integrity of the triple-blind design, the randomization process will be conducted by a designated nurse who has no involvement in the study. The randomization procedure involves assigning each patient a unique number, which is entered into the website. The website then allocates a randomized code corresponding to a pre-labeled box containing either oxycodone or placebo. Each box is pre-assigned a code by the software, and only the designated, uninvolved individual has access to the key that links codes to their respective contents. Patients will receive the study medication box corresponding to their assigned number, Blinding description: This trial will be conducted as a triple-blind study. Study drugs will be coded into two categories (placebo and oxycodone) by an independent third party with no involvement in the study. Randomization will be performed using software to allocate treatment to patients without human intervention. Each participant will receive a numbered drug box, prepared according to the randomization software, containing either placebo or the active drug. Neither the patient, nurse, nor treating physician will be aware of the drug allocation (placebo or active drug) during the study. Additionally, the statistical analyst will also be blinded. The treatment code will remain concealed until the data analysis is completed. Unblinding will only occur in cases of medical necessity or at the conclusion of the study, ensuring the integrity of the trial. 2 Knee replacement surgery. Intervention 1: Intervention group: Oral immediate-release oxycodone hydrochloride 5 mg every 12 hours for 4 weeks post-op. Intervention 2: Control group: Matching placebo tablets on same schedule. Yes - There is a plan to make this available What will be shared: All data will be shared after making patients in samples unidentifiable. When: With the publication of the article To whom: All Researchers Conditions: Only statistical analysis is allowed Where to obtain: as a supplementary How to obtain: All researchers will be given access Comments:
public Seyed Hadi Kalantar
Imam Khomeini Hospital, Keshavarz Blvrd,Tehran,Tehran,Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 hadikalantar4@gmail Tehran University of Medical Sciences scientific Seyed Hadi Kalantar
Imam khomeini hospital, Keshavarz blvrd, Valiasr square, Tehran, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 hadikalantar4@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of knee osteoarthritis requiring surgical intervention. Undergo primary total knee arthroplasty. Willingness and ability to provide informed consent. Commitment to comply with the study protocol and complete follow-up. no limit no limit Both Current use of antidepressants or antiepileptic drugs. History of previous surgery on the affected knee. Patients who were involved in this trial for their previous knee (bilateral TKAs), and/or participation in other clinical trials Body Mass Index (BMI) > 40 or < 20. Regular alcohol consumption. Use of any analgesics not prescribed in the study protocol. Known hypersensitivity or contraindication to oxycodone or any other medications in the standard analgesic regimen. Severe hepatic or renal impairment (e.g., serum creatinine > 2.0 mg/dL, liver enzymes > 3 times the upper limit of normal). Active infection or ongoing inflammatory conditions affecting the knee joint. Psychiatric or cognitive conditions impairing the ability to comply with the study protocol. Pregnancy or lactation. Reluctance to cooperate or continue with follow-up. M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group: Oral immediate-release oxycodone hydrochloride 5 mg every 12 hours for 4 weeks post-op. Control group: Matching placebo tablets on same schedule. Patient's knee pain. Timepoint: 1, 7, and 30 days post-surgery. Method of measurement: Visual Analogue Scale score. Knee function and recovery. Timepoint: 1 month and 6 months post-surgery. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Knee function and recovery. Timepoint: 1 month and 6 months post-surgery. Method of measurement: Oxford Knee Score (OKS). Sleep Quality. Timepoint: 1 month post-surgery. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Satisfaction with the surgical outcome. Timepoint: 6 months post-surgery. Method of measurement: scale from 0 to 10. Hospital length of stay. Timepoint: During hospitalization. Method of measurement: Calculating the number of days of hospitalization after surgery. Tehran University of Medical Sciences Approved 2021-10-29 Ethics Committee of Tehran University of Medical Sciences Tehran university of medical science, Keshavarz Blvrd, Tehran,Tehran,iran Tehran Tehran Iran (Islamic Republic of)