Study on the Effect of Dexamethasone and Betamethasone Sodium Phosphate on Leg Swelling in Patients Undergoing Total Hip Replacement
This clinical trial investigates how well dexamethasone can reduce swelling in the lower limbs following total hip replacement surgery. Peripheral oedema, or swelling in the legs, is a common occurrence after hip surgery due to inflammation and changes in blood flow. The swelling can cause discomfort, a feeling of heaviness, and may affect a patient's ability to move around during recovery.
Inclusion criteria: To participate in this study, you must be between 30 and 80 years old and scheduled to undergo primary total hip replacement surgery. You must have a diagnosis of primary hip osteoarthritis, which is a condition where the hip joint wears down over time. Both men and women can participate, and you will need to sign an informed consent form, which confirms that you understand the study and agree to take part.
Exclusion criteria: You cannot participate if you do not develop swelling in your lower leg after surgery, as the study specifically examines post-operative lower limb oedema. You also cannot join if you are not undergoing total hip replacement surgery or if you fall outside the specified age range. Patients who are considered part of a vulnerable population requiring special protection are also excluded from the trial.
Trial focus: The main goal of this study is to evaluate how effectively dexamethasone can reduce leg swelling after hip replacement surgery. Participants will be monitored closely through several stages. Before surgery, measurements of thigh circumference and leg perimeter will be taken, along with blood tests to check inflammation markers. After the hip replacement procedure, participants will receive dexamethasone through an intravenous infusion. Throughout the recovery period, regular measurements will be taken to assess swelling, and blood tests will be repeated to evaluate the treatment's effectiveness. Participants will also undergo physiotherapy tailored to their individual progress, and their recovery will be assessed using pain scales and functional hip scores.
Investigational drug: The medication being tested in this trial is dexamethasone, a corticosteroid that helps reduce inflammation by suppressing the body's immune response. By decreasing inflammation, dexamethasone may help reduce swelling and discomfort, potentially speeding up the healing process and improving mobility after surgery. It can be administered as an injection or oral tablet, and in this study, it is given through an intravenous infusion to manage post-operative lower limb oedema.
Spain