Evaluation of Dexamethasone and Betamethasone Sodium Phosphate on Postoperative Lower Limb Edema in Total Hip Arthroplasty Patients

The primary objective of this study is to evaluate the **anti-inflammatory** role of dexamethasone in reducing postoperative edema in patients undergoing total hip arthroplasty. This is clinically relevant as postoperative lower limb edema can significantly impact patient recovery and mobility, potentially prolonging hospital stays and increasing the risk of complications.

Secondary objectives include:

• Evaluating the reduction of postoperative pain in patients who have been administered dexamethasone preoperatively.
• Studying the influence of different approaches to total hip arthroplasty on the appearance of postoperative edema in the operated limb.
• Describing the influence of intravenous peroperative dexamethasone in improving rapid recovery programs in total hip arthroplasty.

The clinical trial focuses on evaluating the anti-inflammatory role of dexamethasone in reducing **postoperative edema** in patients undergoing total hip arthroplasty. The study population comprises both men and women aged between 30 and 80 years, who are undergoing primary total hip replacement due to a diagnosis of primary hip osteoarthritis. Participants are required to accept and sign the informed consent. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the **anti-inflammatory** role of dexamethasone in reducing postoperative lower limb edema in patients undergoing total hip arthroplasty. This study is a randomized, double-blind, controlled trial, with a planned duration from July 2021 to July 2026. Participants will be randomly assigned to receive either dexamethasone or a saline solution as a comparator, both administered via intravenous perfusion. The trial will include men and women aged 30-80 years who are undergoing primary total hip replacement due to primary hip osteoarthritis and have provided informed consent.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility criteria are assessed, and informed consent is obtained. Following randomization, participants will receive the assigned treatment and undergo a series of follow-up visits to monitor primary endpoints, including thigh circumference, leg perimeter, PCR value, and IL-6 value. Secondary endpoints will also be evaluated, such as sex, age, body mass index, medical history, type of surgical approach, physiotherapy start day, time of admission, postoperative visual analog scale (VAS), and Harris Functional Scale (HHS). The end-of-study visit will conclude the participant's involvement, ensuring all data is collected and any adverse events are addressed.

The expected length of participant involvement is approximately one day, corresponding to the maximum treatment period. Conditions that may lead to early termination from the study include withdrawal of consent, significant protocol deviations, or adverse events that compromise participant safety. The trial is categorized as a Phase IV study, with a low-intervention classification, ensuring adherence to ethical standards and regulatory requirements throughout its conduct.

The clinical trial involves the administration of **DEXAMETHASONE**, an experimental medication, to evaluate its anti-inflammatory role in reducing postoperative edema in patients undergoing total hip arthroplasty. The active substance in this medication is **betamethasone sodium phosphate**, which is chemically derived. The pharmaceutical form of the medication is coded as PHF00169MIG. The medication is administered via **intravenous perfusion**. The dosage is calculated based on the patient's weight, with a maximum daily and total dose of 0.2 mg/kg. The treatment period is limited to one day. Participant compliance with the dosing schedule is monitored throughout the trial.

In addition to the experimental treatment, a **SODIUM CHLORIDE** solution is used as a comparator in the study. This solution, commonly referred to as saline, is also administered via intravenous perfusion. The maximum daily and total dose for the saline solution is 5 ml. The saline solution serves as a standard-of-care therapy to provide a baseline for evaluating the effects of the experimental medication. The pharmaceutical form of the saline solution is also coded as PHF00169MIG. The administration of the saline solution is conducted under the same conditions as the experimental treatment to ensure consistency in the trial's methodology.

The efficacy of the clinical trial titled "Effect of Dexamethasone on Lower Limb Edema in Patients Undertaken for Total Hip Arthroplasty" will be assessed using both primary and secondary endpoints. The primary endpoints include measurements of thigh circumference, leg perimeter, **PCR** (C-reactive protein) value, and **IL-6** (Interleukin-6) value. These parameters are selected to evaluate the anti-inflammatory role of dexamethasone in reducing postoperative edema in patients undergoing total hip arthroplasty.

Secondary endpoints will encompass demographic and clinical factors such as sex, age, body mass index, medical history, type of surgical approach, physiotherapy start day, time of admission, and postoperative assessments using the visual analog scale (VAS) and Harris Functional Scale (HHS). These secondary measures will provide additional insights into the overall impact of the treatment on patient recovery and functional outcomes.