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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Regional De La Citadelle Liege Belgium
Centre hospitalier universitaire de Liege Liege Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
06.06.2023

Trial locations

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.

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 ID:
2023-504204-28-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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