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Study on Preventing Persistent Postoperative Pain in Children Using Mepivacaine Hydrochloride and Drug Combination

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 a specific type of pain relief method called locoregional analgesia in children who have undergone surgery for bone fractures. The main goal is to see if this method can help prevent long-lasting pain after surgery. The study involves children who have had orthopedic trauma surgery, which is a type of surgery to fix broken bones. The trial will use several medications, including nalbuphine, paracetamol, sevoflurane, sufentanil (also known as OX27), ondansetron, morphine, tramadol, mepivacaine, propofol, dexamethasone, ibuprofen, ketoprofen, soya oil, and suxamethonium. Some participants will receive a placebo.

The purpose of the study is to determine if using locoregional analgesia can reduce persistent pain after surgery. Participants will be monitored for their pain levels using a simple pain scale three months after their surgery. The study will also look at other factors, such as the presence of pain at six and twelve months after surgery, any episodes of nausea or vomiting, and the amount of pain medication needed during and after surgery. The trial will last for a period of time, with regular check-ins to assess the participants' pain and recovery progress.

By participating in this study, researchers hope to gather valuable information on how effective locoregional analgesia is in managing post-operative pain in children. This could lead to better pain management strategies for young patients undergoing similar surgeries in the future. The study will continue until enough data is collected to make a clear conclusion about the benefits of this pain relief method.

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

    Joining the study

    Eligibility is determined based on age (5 to 15 years and 3 months), need for surgery due to a fracture, and ability to communicate pain levels.

    Consent is required from the patient and a parent or guardian.

  2. Step 2

    Pre-surgery preparation

    Preparation for surgery includes a review of medical history and current health status.

    Medications may be administered to manage pain and anxiety before surgery.

  3. Step 3

    Surgery and immediate post-operative care

    During surgery, medications such as nalbuphine hydrochloride, sevoflurane, and sufentanil may be used for pain relief and anesthesia.

    After surgery, monitoring occurs in the Post-Interventional Monitoring Room, where pain and nausea are assessed.

  4. Step 4

    Post-operative monitoring

    Pain is measured using a Numerical Rating Scale (NRS) immediately after surgery and at 3, 6, and 12 months.

    Medications like morphine hydrochloride and tramadol hydrochloride may be administered for pain management.

  5. Step 5

    Follow-up assessments

    Follow-up includes assessments at 3, 6, and 12 months to evaluate pain levels and any episodes of nausea or vomiting.

    The DN4 neuropathic pain screening questionnaire is used to assess pain at these intervals.

Who can join the trial?

6 criteria

  • Age between 5 years and less than 15 years and 3 months.
  • Need for surgery to fix a broken bone using a method called **osteosynthesis**. This is a way to hold broken bones together with metal plates, screws, or rods.
  • Must be part of the social security system.
  • Both the patient and one of their parents or guardians must understand and sign a consent form, which is a document that explains the study and agrees to participate.
  • The patient must be fully awake and aware, with a **Glasgow score** of 15. This score is used to measure how conscious someone is, with 15 being fully awake.
  • The patient must be able to describe their pain using words.

Who cannot join the trial?

4 criteria

  • Children who are not between the ages of 2 and 18 years old.
  • Children who have not undergone orthopedic trauma surgery.
  • Children who do not experience post-operative pain after surgery. This means pain that occurs after having surgery.
  • Children who are part of a vulnerable population. This refers to groups of people who might need special protection or care.
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Investigated drugs

Locoregional Analgesia is a type of pain relief method used during and after surgery. It involves numbing a specific area of the body to prevent pain, especially after orthopedic trauma surgery in children. This method aims to reduce the risk of persistent pain following surgery by targeting the nerves in the affected region.

What is already known about the treatment

Locoregional Analgesia – This medication is administered through injection near a specific area of the body to block pain in that region, commonly used during and after surgery. It is currently being studied in clinical trials to assess its effectiveness in preventing persistent postoperative pain in children following orthopedic trauma surgery. The main therapeutic indication is to manage post-operative pain. At the molecular level, it works by blocking nerve signals in the targeted area, preventing pain sensations from reaching the brain. It is classified as a local anesthetic in pharmacology.

Investigated diseases

Post-operative pain after surgery – This condition refers to the pain experienced by patients following a surgical procedure. It is a common occurrence and can vary in intensity from mild to severe. The pain typically arises due to tissue damage and inflammation caused by the surgery. It can affect the patient's ability to move and perform daily activities. Over time, the pain usually decreases as the body heals. However, in some cases, it may persist and require further management.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503499-25-00Protocol codeRC23_0009Estimated enrolment222 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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