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Study on the Safety of Ibuprofen for Patients Experiencing Pain After Hip and Knee Replacement Surgery

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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 understanding the safety of using ibuprofen after major orthopedic surgeries, specifically hip and knee replacements. Ibuprofen is a common medication used to relieve pain and reduce inflammation. The study will look at its effects on patients who have undergone these surgeries and are experiencing acute postoperative pain.

The purpose of the study is to assess both the helpful and potentially harmful effects of taking ibuprofen for eight days after surgery. Participants will be randomly assigned to receive either ibuprofen or an identical capsule that does not contain the active medication, known as a placebo. The study will monitor for any serious health issues, such as heart problems or bleeding, within 90 days after surgery. It will also track any side effects related to ibuprofen, like stomach discomfort or diarrhea, and compare them to side effects from other pain medications, such as nausea or constipation.

Throughout the study, participants will keep a diary of their symptoms and complete a health-related quality of life questionnaire. This will help researchers understand how ibuprofen affects recovery and overall well-being after surgery. The study aims to provide valuable information on the safe use of ibuprofen in managing pain after hip and knee surgeries.

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 trial

    Upon joining the trial, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the study.

    You must meet certain criteria, such as being scheduled for a planned primary hip or knee replacement surgery and being 18 years or older.

  2. Step 2

    Pre-surgery preparation

    Before your surgery, a negative urine pregnancy test is required if you are a woman of childbearing age. You must also use contraception during the trial.

    Your doctor will plan your pain treatment, which will include the use of a type of medication called NSAID (non-steroidal anti-inflammatory drug).

  3. Step 3

    Surgery and initial recovery

    You will undergo your scheduled hip or knee surgery. After the surgery, you will begin your recovery process in the hospital.

  4. Step 4

    Medication administration

    For eight days following your surgery, you will take ibuprofen in the form of a 400 mg coated tablet. This medication is taken orally.

    The ibuprofen is intended to help manage your postoperative pain. The exact dosage and frequency will be determined by your healthcare provider.

  5. Step 5

    Monitoring and diary keeping

    During the eight-day period of taking ibuprofen, you will be asked to keep a diary. This diary will record any side effects you experience, such as stomach pain, reflux, or diarrhea.

    You will also note any side effects related to other pain medications, such as nausea, vomiting, or constipation.

  6. Step 6

    Follow-up assessments

    After 90 days, you will complete a health-related quality of life questionnaire. This will help assess your recovery and overall well-being.

    A similar questionnaire will be completed one year after your surgery to evaluate long-term outcomes.

Who can join the trial?

5 criteria

  • Scheduled for a planned primary hip or knee replacement surgery, including partial hip replacement.
  • Age must be 18 years or older.
  • Pain treatment around the time of surgery must include NSAID, which is a type of medication for pain and inflammation, as decided by the clinical doctor.
  • For women who can have children, a negative urine pregnancy test is required, and they must use birth control.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.

Who cannot join the trial?

10 criteria

  • Patients with a history of allergy or adverse reactions to ibuprofen or other NSAIDs (non-steroidal anti-inflammatory drugs).
  • Patients with a history of stomach ulcers or bleeding in the stomach or intestines.
  • Patients with severe heart, liver, or kidney problems.
  • Patients who are pregnant or breastfeeding.
  • Patients currently taking other medications that may interact with ibuprofen, such as blood thinners.
  • Patients with a history of asthma triggered by aspirin or other NSAIDs.
  • Patients with a history of bleeding disorders.
  • Patients who have had a recent heart attack or stroke.
  • Patients with uncontrolled high blood pressure.
  • Patients with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
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Investigated drugs

Ibuprofen is a medication commonly used to relieve pain and reduce inflammation. In this clinical trial, it is being tested to see how safe and effective it is when given to patients for eight days after they have had major surgeries on their hips or knees. The goal is to understand both the helpful and potentially harmful effects of using ibuprofen during the recovery period after these types of surgeries. Ibuprofen is a non-opioid pain reliever, which means it is not addictive and is often used as an alternative to stronger pain medications. It works by blocking certain substances in the body that cause inflammation and pain.

What is already known about the treatment

Ibuprofen – Ibuprofen is a medication commonly taken by mouth in the form of tablets or capsules. It is widely used in medicine as a non-opioid pain reliever, particularly for managing acute postoperative pain, such as after hip and knee replacement surgeries. The drug works by blocking certain substances in the body that cause inflammation and pain, making it a non-selective non-steroidal anti-inflammatory drug (NSAID). It is classified pharmacologically as an NSAID and is one of the most frequently used medications for pain relief without the use of opioids.

Investigated diseases

  • Acute postoperative pain

    Acute postoperative pain is a type of pain that occurs after surgical procedures. It is typically sharp and intense, resulting from tissue damage during surgery. This pain usually begins immediately after the operation and can last for several days. The intensity of the pain can vary depending on the type and extent of the surgery. It is a normal part of the healing process, but if not managed properly, it can interfere with recovery. Over time, the pain generally decreases as the body heals.

  • Hip and knee arthroplasties

    Hip and knee arthroplasties refer to surgical procedures where damaged or diseased parts of the hip or knee joints are replaced with artificial components. These surgeries are often performed to relieve pain and improve function in individuals with severe joint damage, commonly due to arthritis. Post-surgery, patients may experience pain and swelling as the body adjusts to the new joint. Recovery involves a period of rehabilitation to restore movement and strength. Over time, the artificial joint helps improve mobility and reduce discomfort. The progression of recovery varies among individuals, depending on factors like age, health, and adherence to rehabilitation protocols.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502502-32-00Estimated enrolment2 904 patientsSponsorSlagelse Hospital

sourced from the EU Clinical Trials Register and site verification

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