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Study on Pain Relief After Hip Replacement Surgery Using Morphine, Ropivacaine, and Bupivacaine for Patients Undergoing Spinal Anesthesia

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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 improving pain relief after a surgery called total hip replacement, which is performed under spinal anesthesia. The study is investigating the effectiveness of using intrathecal morphine, a type of pain medication injected into the spinal area, with or without another medication called ropivacaine, which is used in a specific type of nerve block known as the suprainguinal fascia iliaca block. The goal is to see if these treatments can help reduce pain and improve comfort when moving around after the surgery.

Participants in the study will receive either the pain medication or a placebo. The study will monitor pain levels using a simple scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. This will be checked 8 hours after the surgery and at various times over the next two days. The study will also look at how much additional pain medication is needed during the first 48 hours after surgery and will track any side effects or complications that might occur, such as nausea or dizziness.

The study aims to provide valuable information on how to manage pain effectively after hip replacement surgery, potentially leading to better recovery experiences for patients. Participants will be asked about their pain experiences and overall recovery at different points in time, including the first and second days after surgery, as well as one week and one month later. This information will help assess the overall quality of recovery and the effectiveness of the pain management strategies being tested.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, health status, and language proficiency.

    Participants are scheduled for elective total hip replacement surgery with spinal anesthesia.

  2. Step 2

    Pre-surgery preparation

    Before surgery, participants receive a detailed explanation of the procedure and the trial's objectives.

    Participants are informed about the use of intrathecal morphine and possibly ropivacaine for pain management.

  3. Step 3

    Surgery and initial treatment

    During surgery, intrathecal morphine is administered to manage postoperative pain.

    Some participants may also receive a suprainguinal fascia iliaca block with ropivacaine.

  4. Step 4

    Post-surgery monitoring

    Pain levels are assessed using a numeric rating scale (NRS) 8 hours after surgery.

    Participants are monitored for pain at rest and during movement at specific times: 8 hours post-surgery, and at 8:00 am, 1:00 pm, and 6:00 pm on the first and second days after surgery.

  5. Step 5

    Pain management

    Participants have access to a Patient Controlled Intravenous Analgesia (PCIA) device for additional morphine if needed.

    Total morphine consumption is recorded during the first 48 hours post-surgery.

  6. Step 6

    Assessment of side effects

    Participants are monitored for side effects such as nausea, dizziness, and constipation.

    Any complications like orthostatic intolerance or falls are documented.

  7. Step 7

    Patient experience evaluation

    On the second day after surgery, participants complete the International Pain Outcome (IPO) questionnaire to assess their pain experience.

    Functional recovery is evaluated using the Quality-of-Recovery 15-items (QoR-15) score on the first, second, seventh, and thirtieth days post-surgery.

Who can join the trial?

4 criteria

  • Must be an adult man or woman over 18 years old and less than 85 years old.
  • Must have an American Society of Anesthesiologists (ASA) Physical Status of 1, 2, or 3. This is a way to classify how healthy you are before surgery, with 1 being the healthiest and 3 having more health issues.
  • Must be able to speak, read, and understand French.
  • Must be admitted for a planned total hip replacement surgery using spinal anesthesia, which is a type of anesthesia that numbs the lower part of your body.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing total hip arthroplasty (a type of hip surgery) under spinal anesthesia (a type of anesthesia that numbs the lower part of the body).
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specified clinical trial group.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Morphine

    is used in this trial to help manage pain after surgery. It is given through an injection into the spinal area, which is known as intrathecal administration. This method allows the medication to work directly on the nerves in the spinal cord to provide pain relief.

  • Ropivacaine

    is used in this trial as part of a nerve block technique called the supra-inguinal fascia iliaca compartment block. This medication is a local anesthetic that helps numb the area around the hip to reduce pain after surgery. It is used in combination with morphine to enhance pain relief.

What is already known about the treatment

  • Morphine

    This medication is administered intrathecally, meaning it is injected into the spinal canal, specifically for managing pain after surgeries like total hip arthroplasty. Morphine is well-established in medical literature as a potent pain reliever, particularly in postoperative settings. It is primarily used to alleviate severe pain by binding to opioid receptors in the brain and spinal cord, which reduces the perception of pain. Morphine is classified as an opioid analgesic.

  • Ropivacaine

    This medication is used in a regional anesthesia technique known as the supra-inguinal fascia iliaca compartment block. It is currently being studied for its effectiveness in combination with intrathecal morphine to enhance pain relief after total hip arthroplasty. Ropivacaine works by blocking nerve signals in the body, which helps to numb the area and reduce pain. It is classified as a local anesthetic.

Investigated diseases

Total Hip Arthroplasty – Total hip arthroplasty, commonly known as hip replacement, is a surgical procedure where a damaged hip joint is replaced with an artificial one. This condition often arises due to severe arthritis or injury, leading to pain and limited mobility. The surgery involves removing the damaged bone and cartilage and replacing them with prosthetic components. Post-surgery, patients typically experience a period of recovery where they gradually regain mobility and strength. The procedure aims to relieve pain, improve function, and enhance the quality of life. Recovery and rehabilitation are crucial for the successful outcome of the surgery.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511946-38-00Estimated enrolment114 patientsSponsorCentre Hospitalier Universitaire De Liege

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