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

Determining the effect of oral oxycodone for four weeks after surgery on pain and function of patients after primary knee replacement.

Randomized (by sealdenvelope.com) controlled clinical trial, parallel groups, double-blind, in phase 3 on 2 groups of 30 patients underwent complete knee replacement.

Patients undergoing complete knee replacement surgery at Imam Khomeini Hospital in Tehran were randomly divided into 2 groups of 30 (placebo and oxycodone) and the patient, physician and nurse were double blinded not being aware of the prescribed drug by categorizing drug coding by another person not related to the study.

Inclusion criteria: Patients with knee osteoarthritis undergone total knee replacement Exclusion criteria: Drug and alcohol use, use of any other analgesics and antidepressants, and anti-epilepsy, previous history of surgery on the affected knee, intraoperative fracture, unwillingness of the patient to cooperate or continue follow-up, and bmi above 40 and Less than 20

a double-blind clinical trial in two groups of patients with knee osteoarthritis who underwent primary knee replacement surgery received standard analgesic therapy (Celebrex BD / 75mg Layrica; QID / 500 Acetaminophen; BD / 200m). From post op to discharge followed by acetaminophen 500 mg Q6H 200 Celebrex capsules Q12H for 4 weeks in both groups. Placebo is prescribed to the control group and oral oxycodone (10 mg) to the case group every 6 hours for two weeks.

Oxycodone consumption and its analgesia can reduce the use of common oral analgesics that increase the risk of gastric bleeding due to consumption Simultaneously with aspirin or other anticoagulants

In each group, 30 people will be randomly selected individually using the sealdenvelope.com website. This was done by another nurse who has no role in the study in order not to disturb double blindness. The process is to firstly give the software all patient's numbers and it would allocate each patient a code that is written already on the boxes randomly. The box can consist of placebos or oxycodone. Only the one person who is not involved in the study can know which box consists of which specimen, The box that is given to the patients is driven by the number allocated by the software. For example, the patient NO.7 will receive box number 43 which is chosen by the program randomly

Drugs are coded into two groups: placebo and main group (oxycodone). This is done by someone else who has no role in the study and is given to patients randomly. The patient and the nurse and the treating physician did not know about the type of drugs code 1 and 2 during the study. As described before in the randomization section, the process of allocating the drug or placebo to each patient is done by software with no human interfering in it. Each patient has a box number allocated to them by the software, in the box either the placebo or the main drug can exist. Not until after the data analysis the researcher can not find out about the codes (i.e the patient NO.28 has received which of them)

All data can be shared after making people in samples unidentifiable.

Starting April 2023

Researchers working at the university

Only statistical analysis is allowed

Tehran university of medical science

Access will be established after coordination with Tehran University of Medical Sciences and orthopedic department