Comparing pain intensity and range of motion after using combination of NSAID and Acetaminophen with opioid analgesic protocol after high tibial osteotomy

Comparing pain intensity and range of motion after using combination of NSAID and Acetaminophen with opioid analgesic protocol after high tibial osteotomy in patients referred to Valiasr Faraja hospital in Tehran city.

The design of this study is a parallel clinical trial in phase 2-3. It has a control group where patients will be assigned to study groups by block randomization method. The sample size is 30 patients. Blinding will not be done in this study.

The aim of this study is the effect of different combinations of pain relievers on pain intensity and range of motion of patients undergoing proximal tibial osteotomy in Valiasr Faraja hospital. Both patients and evaluators of study outcomes will know the type of painkillers received.

The most important conditions for entering the study are patients undergoing proximal tibial osteotomy and being physically active. The most important non-inclusion criteria are having pain and range of motion beyond the limit before surgery, patients experiencing infection during the study, and receiving a pain pump after surgery.

In this study, two groups of patients receiving different analgesic compounds will be compared. The patients in the intervention group will receive NSAID and acetaminophen, and the patients in the control group will receive oxycodone opioid.

Range of motion; Pain intensity

The block randomization method was used in this study. The size of the blocks is considered to be six and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A, B. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output.

Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.

Availability six months after the end of study.

Specialists in orthopedics, surgery, anesthesiologists, internists.

Requests may be made by organizations, journals or project supervisors. These requests will be read by the research team under the supervision of a institute representative, and if the requests are reasonable, relevant de-identified data will be sent. This request may be some results of biomarkers or codes performed for data analysis.

The initial request can be sent to the e-mail of the people who are in the scientific and general response section of the trial (nimat92@yahoo.com). Also, the applicants can go to the Applied Research Center of Behdad Vice-Chancellor located in Valiasr Faraja Hospital in Tehran or the Clinical Trial Center of Iran which It is referred to in the central library of Iran University of Medical Sciences.

After the institution agrees to send data for requests, depending on whether the requester is inside the country or abroad, and also according to the type of requested data, the time to respond to the requests will be different. Finally, no request will take more than one month.