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Comparing Two Doses of Dexamethasone to Improve Quality of Life in Patients 60 Years and Older Having Total Hip Replacement Surgery

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 study looks at patients aged 60 years or older who are having total hip replacement surgery, which is a procedure to replace a damaged hip joint with an artificial one. The treatment being tested is dexamethasone, a type of medication called a corticosteroid that helps reduce swelling and inflammation in the body. Two different doses of dexamethasone will be used during the surgery: a lower dose of 5 milligrams and a higher dose of 25 milligrams. Both doses will be given as a single injection into a vein during the operation.

The purpose of this study is to find out how different doses of dexamethasone affect quality of life for patients in the three months after hip replacement surgery. Quality of life refers to how well a person feels in their daily activities, including their physical comfort, ability to move around, and overall well-being. The study will compare the effects of the lower dose against the higher dose to see which one works better for helping patients recover and feel better after their surgery.

During the study, patients will receive one of the two doses of dexamethasone during their hip replacement operation. After the surgery, patients will be asked to complete questionnaires at different time points to measure how they are feeling and recovering. These questionnaires will ask about their quality of life, recovery progress, hip function, pain levels, and tiredness at various times following the surgery, including on days 1, 3, and 5, as well as at 30, 60, and 90 days after the operation. The study will help doctors understand which dose of dexamethasone might be more helpful for patients recovering from hip replacement surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Surgery day and medication administration

    On the day of your hip replacement surgery, you will receive your assigned dose of dexamethasone during the operation.

    Dexamethasone is a medication that helps reduce inflammation and may improve recovery after surgery.

    You will receive either 5 mg or 25 mg of dexamethasone as a single dose given through a vein during the procedure.

    The surgery will be performed under spinal anesthesia, which numbs the lower part of your body while you remain awake or lightly sedated.

  2. Step 2

    Early recovery assessment

    During the first 5 days after surgery, you will be asked to complete questionnaires on day 1, day 3, and day 5.

    These questionnaires will assess your quality of recovery, asking about your physical comfort, emotional state, and ability to perform daily activities.

  3. Step 3

    First month follow-up

    At 30 days after your surgery, you will complete several questionnaires.

    These will assess your health-related quality of life, asking about your mobility, self-care, usual activities, pain, and anxiety or depression.

    You will also rate your overall health on a scale.

    Additional questionnaires will evaluate your hip function, asking about pain and ability to perform activities like walking and putting on shoes.

    You will be asked about any pain you are experiencing and how it affects your daily life.

    A questionnaire about fatigue will assess your energy levels and tiredness.

  4. Step 4

    Second month follow-up

    At 60 days after your surgery, you will complete the same set of questionnaires as at day 30.

    These will again assess your health-related quality of life, hip function, pain levels, and fatigue.

  5. Step 5

    Third month follow-up

    At 90 days after your surgery, you will complete the final set of questionnaires.

    These will be the same as those completed at day 30 and day 60, assessing your health-related quality of life, hip function, pain levels, and fatigue.

    This marks the end of your participation in the study.

Who can join the trial?

3 criteria

  • You must be 60 years old or older
  • You must be scheduled for elective total hip arthroplasty, which is a planned surgery to replace your hip joint
  • Your surgery must be performed using spinal anaesthesia, which is a type of pain relief where medicine is injected into your lower back to numb the lower half of your body during the operation

Who cannot join the trial?

4 criteria

  • No specific exclusion criteria (reasons why you cannot participate) have been listed for this clinical trial
  • However, you must be 60 years of age or older to participate
  • You must be scheduled to have total hip arthroplasty, which is a surgery to replace your hip joint
  • The study doctor will review your medical history and current health condition to determine if you are suitable for the study
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Investigated drugs

  • Dexamethasone

    is a corticosteroid medication that helps reduce inflammation and swelling in the body. In this study, it is given as a single dose during hip replacement surgery to see if it can improve how patients feel and their quality of life in the months following the operation.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in research studies to compare against the actual treatment to see if the real medication works better than no treatment at all.

What is already known about the treatment

Dexamethasone – Dexamethasone is a corticosteroid medication that is given as an injection during surgery to help reduce inflammation and improve recovery after medical procedures. In this clinical trial, it is being studied in two different doses (5 mg and 25 mg) to see how well it helps improve quality of life in older patients who are having hip replacement surgery. The medication works by blocking the body's inflammatory response at the cellular level, which can help reduce swelling, pain, and nausea after surgery. Dexamethasone is a well-established medicine that belongs to a class of drugs called glucocorticoids, which are commonly used to control inflammation in various medical conditions.

Investigated diseases

Osteoarthritis of the Hip – This is a degenerative joint disease that affects the hip joint, where the protective cartilage that cushions the ends of bones gradually wears away over time. As the cartilage breaks down, the bones begin to rub against each other, causing pain, stiffness, and reduced mobility in the hip area. The condition typically develops slowly and worsens over years, making it difficult to perform daily activities such as walking, climbing stairs, or getting in and out of chairs. Patients often experience pain in the groin, thigh, or buttock area, especially during movement or after periods of inactivity. The joint may become less flexible, and some people may hear grinding or clicking sounds when moving their hip. When the disease progresses to a severe stage where conservative measures no longer provide relief, total hip arthroplasty may become necessary to restore function and reduce pain.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524368-39-00Estimated enrolment234 patientsSponsorZiekenhuis Oost Limburg

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