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Study on the Effect of Dexamethasone and Betamethasone Sodium Phosphate on Leg Swelling in Patients Undergoing Total Hip Replacement

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication dexamethasone on swelling in the lower limbs, which can occur after surgery, specifically in patients who have undergone a total hip replacement. The purpose of the study is to evaluate how well dexamethasone can reduce this type of swelling, known as post-operative lower limb edema. Dexamethasone is a medication that helps reduce inflammation, which is the body's response to injury or surgery.

In this study, participants will receive either dexamethasone or a placebo through an intravenous infusion, which means the medication is given directly into a vein. Another group will receive a saline solution, which is a simple saltwater solution often used in medical treatments. The study will observe the effects of these treatments over a short period, typically just one day, to see how they impact the swelling in the legs after hip surgery.

The trial aims to gather information on how effective dexamethasone is in reducing swelling and to understand its role in managing inflammation after surgery. This information could help improve recovery for patients undergoing hip replacement surgery by potentially reducing discomfort and speeding up the healing process. Participants will be monitored for changes in their leg size and other health indicators to assess the treatment's impact.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

    You must meet the following criteria: be between 30 and 80 years old, be scheduled for a primary total hip replacement, and have a diagnosis of primary hip osteoarthritis.

  2. Step 2

    Pre-surgery assessment

    Before the surgery, measurements such as thigh circumference and leg perimeter will be taken. Blood tests will be conducted to determine PCR (a marker of inflammation) and IL-6 (an indicator of immune response) levels.

  3. Step 3

    Surgery and initial treatment

    You will undergo total hip arthroplasty, which is a surgical procedure to replace the hip joint.

    After the surgery, you will receive an intravenous infusion of dexamethasone to help reduce inflammation and swelling. The dosage and frequency will be determined by the medical team based on your specific needs.

  4. Step 4

    Post-surgery monitoring

    Following the surgery, your recovery will be closely monitored. This includes regular checks of your thigh circumference and leg perimeter to assess swelling.

    Blood tests will be repeated to measure PCR and IL-6 levels, helping to evaluate the effectiveness of the treatment.

  5. Step 5

    Physiotherapy and recovery

    You will begin physiotherapy to aid in your recovery. The start day and type of physiotherapy will be tailored to your individual progress.

    Your recovery will be assessed using the visual analog scale (VAS) for pain and the Harris Functional Scale (HHS) for hip function.

  6. Step 6

    Final assessment

    At the end of the study period, a final assessment will be conducted. This will include measuring your thigh circumference, leg perimeter, and conducting blood tests for PCR and IL-6 levels.

    Your overall recovery and the effectiveness of the treatment will be evaluated based on these measurements and your functional scores.

Who can join the trial?

4 criteria

  • Men and women aged 30-80 years
  • Patients undergoing primary total hip replacement (a surgery to replace the hip joint with an artificial one)
  • Diagnosis of primary hip osteoarthritis (a condition where the hip joint wears down over time)
  • Accept and sign the informed consent (a document that explains the study and confirms your agreement to participate)

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing post-operative lower limb edema cannot participate. This means if you do not have swelling in your lower leg after surgery, you cannot join.
  • Patients who are not undergoing total hip arthroplasty are excluded. This means if you are not having a total hip replacement surgery, you cannot participate.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Both male and female patients can participate, but if you do not identify as either, you may be excluded.
  • Patients who are considered part of a vulnerable population are excluded. This means if you are in a group that needs special protection, you cannot join.
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Investigated drugs

Dexamethasone is a medication used in this clinical trial to help reduce swelling and inflammation. It is being tested to see if it can decrease the swelling in the lower limbs of patients who have undergone total hip replacement surgery. By reducing inflammation, dexamethasone may help patients recover more comfortably and quickly after their surgery.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered in the form of an injection or oral tablet, and it is used to reduce inflammation and swelling. Currently, it is being studied for its effectiveness in reducing swelling in the lower limbs after hip replacement surgery. The main therapeutic use of dexamethasone in this context is to manage post-operative lower limb edema. At the molecular level, dexamethasone works by suppressing the immune system's inflammatory response, which helps to decrease swelling and pain. It is classified as a corticosteroid, a type of medication that mimics hormones produced by the adrenal glands.

Investigated diseases

Postoperative Lower Limb Edema – This condition involves swelling in the lower limb that occurs after surgery, such as total hip arthroplasty. It is characterized by an accumulation of fluid in the tissues of the leg, leading to increased limb size and discomfort. The swelling typically develops due to inflammation and changes in blood flow following the surgical procedure. Over time, the edema may decrease as the body gradually reabsorbs the excess fluid. The condition can affect mobility and may be accompanied by a feeling of heaviness in the affected limb. Monitoring and managing the swelling is important to ensure proper recovery and function of the limb.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518133-28-00Protocol codeDXMTEstimated enrolment62 patientsSponsorHospital Universitari De Girona Doctor Josep Trueta

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