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Comparing ropivacaine and bupivacaine for pain relief after hip replacement surgery in patients with hip osteoarthritis

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 is looking at patients who have hip osteoarthrosis and will undergo surgery to replace their hip joint, which is called total hip arthroplasty. Hip osteoarthrosis is a condition where the cartilage in the hip joint wears down over time, causing pain and stiffness. The study will also examine pain that occurs after the surgery. Two different medications will be used to numb the area during the operation: ropivacaine hydrochloride and bupivacaine hydrochloride. Both medications are given as an injection into the fluid around the spinal cord, which is called intrathecal use, to block pain signals during and after the surgery.

The goal of this study is to compare how well these two medications work in terms of safety and effectiveness when patients have hip replacement surgery that allows them to go home the same day. The study will look at how long it takes for feeling and movement to return after the numbing medication wears off, how many patients can go home on the same day as their surgery, and how long patients need to stay in the recovery area and hospital. Other things that will be measured include how much pain patients feel after surgery using a number scale, whether patients have difficulty urinating, if they experience nausea or vomiting, how much pain medication they need after surgery, how satisfied patients are with their care, blood pressure and heart rate during the procedure, how quickly the numbing effect starts, and whether the numbing medication works well enough during the surgery.

Patients in this study will receive one of the two numbing medications as a single injection before their hip replacement surgery. The study is designed so that neither the patients nor the doctors know which medication is being given until after the study is complete, which helps ensure fair results. The medications will be given at specific doses, with ropivacaine given at up to sixteen milligrams and bupivacaine given at up to thirteen and a half milligrams, both administered once on the day of surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Receiving spinal anesthesia

    You will receive a single injection into the spinal space (the area around the spinal cord) before your hip replacement surgery.

    The injection will contain one of two medications: either ropivacaine at a concentration of 5 mg per milliliter or bupivacaine at a concentration of 5 mg per milliliter. Both medications are local anesthetics that block pain and sensation.

    The specific medication you receive will be determined randomly, and neither you nor the medical staff will know which one you are receiving during the procedure.

  2. Step 2

    Hip replacement surgery

    Your total hip replacement surgery will be performed while you are under spinal anesthesia.

    The surgery is planned as same-day surgery, meaning you may be discharged on the same day if your condition allows.

  3. Step 3

    Monitoring in the recovery area

    After surgery, you will be monitored in the postoperative care unit.

    Medical staff will observe the return of feeling and movement in your legs, as the anesthetic effect gradually wears off.

    The time you spend in this recovery area will be recorded.

    Your blood pressure and heart rate will be monitored during this period.

  4. Step 4

    Pain assessment

    Your pain level will be assessed using a Numeric Rating Scale, where you will rate your pain from 0 (no pain) to 10 (worst pain imaginable).

    This assessment will be performed at regular intervals after surgery.

  5. Step 5

    Monitoring for side effects

    You will be monitored for urinary retention (difficulty urinating).

    You will be observed for nausea and vomiting.

    Any pain medication you receive after surgery will be recorded. These medications will be converted to a standard measurement called morphine milligram equivalents for comparison purposes.

  6. Step 6

    Assessment of satisfaction

    You will be asked to rate your satisfaction with the anesthesia and pain management using a 5-point scale.

  7. Step 7

    Discharge or continued hospital stay

    If your condition meets the discharge criteria, you may be released on the same day as your surgery.

    If you need to stay longer, the total length of your hospital stay will be recorded.

    The decision about discharge will be based on established guidelines, including your overall health status.

Who can join the trial?

6 criteria

  • You must be between 18 and 80 years old
  • You must be scheduled for a planned total hip replacement surgery, which is a procedure to replace a damaged hip joint with an artificial one, and this must be your first hip replacement on that joint
  • You must be suitable to go home on the same day as your surgery, which will be decided based on local medical guidelines
  • Your overall health status must be good enough for same day discharge, including having an ASA score of 1 or 2, which means you are either healthy or have mild health conditions that are well controlled
  • Your BMI must be less than 35, where BMI stands for body mass index, a measure that uses your height and weight to estimate body fat
  • You must understand the study information and sign a consent form agreeing to participate

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
  • Exclusion criteria are conditions or factors that would prevent someone from joining a study to ensure patient safety and accurate results
  • Without detailed exclusion information, it is not possible to list the specific reasons that would prevent participation in this particular study
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Investigated drugs

  • Ropivacaine

    is a local anesthetic medication that is injected into the spinal area to numb the lower part of the body during surgery. It works by blocking nerve signals so you don't feel pain during the hip replacement operation. In this study, it is being tested to see how well it controls pain after surgery and how long the numbness lasts.

  • Bupivacaine

    is another local anesthetic medication that is also injected into the spinal area to block pain during surgery. Like ropivacaine, it numbs the lower body by stopping nerve signals from reaching the brain. This medication is already commonly used for hip surgeries, and in this study it is being compared with ropivacaine to see which one works better for pain control and has fewer side effects.

What is already known about the treatment

  • Ropivacaine

    Ropivacaine is a local anesthetic medication that is injected into the spinal canal to block pain signals during and after surgery. It works by temporarily blocking sodium channels in nerve cells, which prevents these nerves from sending pain messages to the brain. This medication is commonly used for spinal anesthesia during hip replacement surgeries and is valued for providing effective pain relief while allowing patients to recover mobility relatively quickly. In this clinical trial, researchers are comparing ropivacaine with another similar anesthetic to determine which provides better pain control and safety for patients having hip surgery.

  • Bupivacaine

    Bupivacaine is a well-established local anesthetic that is administered through injection into the spinal area to numb the lower body during surgical procedures. It functions by blocking the sodium channels in nerve fibers, which stops pain signals from traveling through the nerves to the brain and spinal cord. This medication has been used for many years in spinal anesthesia for various surgeries, including hip replacements, and is known for providing long-lasting pain relief. In this study, bupivacaine serves as the comparison treatment to evaluate how it performs against ropivacaine in terms of pain control duration and patient safety.

Investigated diseases

  • Hip Osteoarthritis

    Hip osteoarthritis is a condition where the cartilage in the hip joint gradually wears away over time. As the protective cartilage breaks down, the bones in the joint begin to rub against each other. This process leads to pain, stiffness, and reduced movement in the hip area. The condition typically develops slowly and worsens progressively. People with this disease may experience difficulty walking, climbing stairs, or performing daily activities. The hip joint becomes increasingly damaged as the disease advances.

  • Postoperative Pain

    Postoperative pain is discomfort that occurs after a surgical procedure. It begins immediately following surgery and can last for days or weeks depending on the type of operation performed. The pain results from tissue damage, inflammation, and nerve irritation caused by the surgical incision and manipulation of body structures. The intensity of pain typically decreases gradually as the body heals. This type of pain can affect the area where surgery was performed and sometimes surrounding regions. The duration and severity vary based on the extent of the surgical intervention.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522358-38-02Estimated enrolment162 patientsSponsorTurku University Hospital

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