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Study on Pain Relief After Lumbar Spinal Surgery Using Erector Spinae Plane Block with Etoricoxib and Drug Combination for Patients Undergoing Lumbar Arthrodesis

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 evaluating the effectiveness of a pain management technique called the erector spinae plane block in patients undergoing lumbar spinal surgery, specifically lumbar arthrodesis. Lumbar arthrodesis is a type of back surgery where two or more vertebrae in the lower back are fused together to reduce pain and improve stability. The study aims to assess whether this technique can reduce the need for pain medications, such as morphine, after surgery.

Participants in the study will receive either the erector spinae plane block or a placebo during their surgery. The block is a type of anesthesia that numbs the nerves in the back to help manage pain. The study will compare the amount of morphine needed by patients who receive the block to those who do not, over the first 24 hours after surgery. The trial will also monitor other factors such as blood pressure, heart rate, and any complications related to the block, as well as the overall quality of recovery.

In addition to morphine, other medications used in the study include etoricoxib, paracetamol, tramadol hydrochloride, methylprednisolone, propofol, lidocaine hydrochloride monohydrate, sevoflurane, sufentanil, rocuronium bromide, and levobupivacaine hydrochloride. These medications are commonly used for pain relief, anesthesia, and muscle relaxation during and after surgery. The study will help determine the best approach to managing pain and improving recovery for patients undergoing lumbar spinal 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (18 to 85 years) and health status (ASA 1 or 2).

    The study involves patients scheduled for lumbar arthrodesis surgery involving 1 to 3 levels.

  2. Step 2

    Pre-surgery preparation

    Before surgery, a detailed explanation of the procedure and the study is provided.

    Consent is obtained to participate in the study.

  3. Step 3

    Surgery and medication administration

    During surgery, various medications are administered:

    Etoricoxib is given orally as a film-coated tablet.

    Morphine hydrochloride, tramadol hydrochloride, methylprednisolone, propofol, lidocaine hydrochloride monohydrate, and sufentanil are administered as intravenous injections.

    Paracetamol is given as an intravenous infusion.

    Rocuronium bromide and levobupivacaine hydrochloride are used for injection or infusion.

    Sodium chloride is used as a solvent for parenteral use.

    Sevoflurane is administered as an inhalation vapor.

  4. Step 4

    Post-surgery monitoring

    Post-surgery, the primary focus is on monitoring morphine consumption within the first 24 hours.

    Intraoperative parameters such as blood pressure and heart rate are analyzed.

    Pain levels and opioid use in the post-anesthesia care unit (PACU) are assessed.

  5. Step 5

    Recovery and discharge

    The quality of postoperative recovery is evaluated using the QoR-15 score.

    The length of hospitalization is recorded, along with any complications such as nausea or constipation.

    The study aims to determine the effectiveness of the erector spinae plane block in reducing opioid consumption.

Who can join the trial?

5 criteria

  • All genders are welcome to participate, meaning both men and women can join.
  • Participants should be between the ages of 18 and 85 years old.
  • Participants must be classified as **ASA 1 or 2**. This means they are either healthy or have mild, well-controlled health issues.
  • Participants must be scheduled for **lumbar arthrodesis surgery**. This is a type of back surgery that involves fusing bones in the lower spine.
  • The surgery should involve 1 to 3 levels of the spine.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing **lumbar arthrodesis**. This is a type of back surgery where bones in the lower spine are fused together.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a clinical trial group that is not included in this study.
  • 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 a medication used to relieve severe pain. In this clinical trial, it is used to manage pain after lumbar spinal surgery. The study aims to evaluate how much morphine is needed by patients who have undergone surgery, comparing those who receive an additional pain management technique to those who do not.

  • Erector Spinae Plane Block

    is a type of regional anesthesia technique used to manage pain. In this trial, it is administered to some patients undergoing lumbar spinal surgery to see if it reduces the need for morphine after the operation. This technique involves injecting a local anesthetic near the spine to block pain signals.

What is already known about the treatment

Morphine – Morphine is typically administered through injection or orally in tablet form. It is a well-established medication in medical literature, widely used for pain management. The main therapeutic indication for morphine is to relieve severe pain, such as that experienced after surgery. At the molecular level, morphine works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

Lumbar Arthrodesis – Lumbar arthrodesis is a surgical procedure aimed at fusing two or more vertebrae in the lower back to eliminate motion between them. This procedure is often performed to alleviate pain caused by conditions such as degenerative disc disease, spinal instability, or spondylolisthesis. During the surgery, bone grafts or metal implants are used to promote bone growth between the vertebrae, eventually leading to a solid fusion. Over time, the fused vertebrae heal into a single, solid bone, reducing pain and improving stability. The recovery process can vary, with patients typically experiencing a gradual improvement in mobility and reduction in pain.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504204-28-00Estimated enrolment126 patientsSponsorCHU De Liege

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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