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Study of Ropivacaine and Dexamethasone Nerve Block for Patients with Acute Low Back Pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines acute low back pain that is non-specific, meaning pain in the lower back area that has no clear identified cause and has been present for five days or less. The treatment being tested is called an erector spinae plane block, which is a procedure where medication is injected near the muscles along the spine to help reduce pain. During this procedure, patients will receive either the active treatment or placebo. The medications used in the study include dexamethasone phosphate and ropivacaine hydrochloride as injections for the nerve block procedure, and sodium chloride solution for the placebo injection. Additional pain medications that may be used during the study include paracetamol given as tablets or through infusion, ketoprofen given as tablets or through infusion, and tramadol hydrochloride as extended-release tablets for additional pain relief if needed.

The purpose of this study is to find out if the erector spinae plane block is effective in helping patients with non-specific low back pain by reducing their pain and allowing them to move around more easily right away. The study will look at whether this treatment can decrease pain by half and improve the ability to walk within thirty minutes after the procedure is performed.

During the study, patients will undergo the procedure and then be followed for six months. Pain levels will be measured at various times, starting from thirty minutes after the procedure and continuing through the follow-up period. The study will track how well patients can move, how much pain medication they need to take, how many steps they can walk each day in the first few days, and how well they sleep during the first three days. Patients will complete questionnaires at different time points to assess their pain, physical function, quality of life, and any side effects from the pain medications. Information will also be collected about medical visits, physical therapy sessions, any return of back pain, and when patients are able to return to work during the six-month follow-up period.

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

    Initial assessment and procedure

    Your pain level will be measured using a pain scale (a score from 0 to 10) during movement.

    Your ability to walk will be tested using the Get Up and Go test, which measures how long it takes you to stand up, walk a short distance, and sit back down.

    You will receive either the erector spinae plane block (a type of injection near the spine to block pain signals) or a comparison treatment.

    After 30 minutes, your pain level during movement will be measured again to see if it has decreased by at least 50 percent.

    After 30 minutes, the Get Up and Go test will be repeated to check if you can complete it in less than 20 seconds.

  2. Step 2

    Day 0 to day 3 monitoring

    You will record your pain levels using the pain scale each day.

    Your daily step count will be tracked from day 0 to day 3.

    You will record information about your sleep, including how long you slept, how long it took to fall asleep, and how many times you woke up during the night.

    If needed, you may take tramadol hydrochloride (a pain relief medication) as a rescue medication. The exact dosage will be determined by the study protocol.

    On day 3, you will complete the EIFEL questionnaire, which assesses how back pain affects your daily activities.

  3. Step 3

    Day 14 assessment

    You will complete the Brief Pain Inventory questionnaire, which evaluates how pain affects your daily life and activities.

    You will complete the WOMAC questionnaire, which measures pain, stiffness, and physical function.

    You will complete the POMI questionnaire, which assesses potential misuse of pain medications.

    You will continue to record the total number of tramadol tablets taken since the procedure.

  4. Step 4

    Month 3 assessment

    You will complete the Brief Pain Inventory questionnaire again.

    You will complete the WOMAC questionnaire again.

    You will complete the POMI questionnaire again.

    You will complete the SF-12 questionnaire, which measures your overall health and quality of life.

    You will report the number of medical visits you have had for low back pain since the procedure.

    You will report the number of physical therapy sessions you have attended for low back pain.

    You will report any episodes where your low back pain returned.

    You will continue to record pain levels and any side effects from pain medications, such as nausea or vomiting.

  5. Step 5

    Month 6 final assessment

    You will complete the Brief Pain Inventory questionnaire for the final time.

    You will complete the WOMAC questionnaire for the final time.

    You will complete the POMI questionnaire for the final time.

    You will complete the SF-12 questionnaire again.

    You will complete the EQ-5D-5L questionnaire, which assesses your quality of life across five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

    You will report the total number of medical visits for low back pain up to this point.

    You will report the total number of physical therapy sessions for low back pain up to this point.

    You will report the total number of times your low back pain returned.

    You will report the number of days it took from the procedure until you returned to work.

    You will report any side effects experienced from rescue pain medications throughout the entire study period.

    The total number of tramadol tablets taken from day 0 to month 6 will be recorded.

Who can join the trial?

4 criteria

  • You must be an adult, which means you need to be 18 years old or older
  • You must have non-specific low back pain, which is pain in your lower back that does not have a clear or known cause, and this pain must have started 5 days ago or less recently
  • Your pain score must be 5 or higher on a scale from 0 to 10 when you move around, where 0 means no pain and 10 means the worst pain possible
  • You must have difficulty walking easily, which is tested by a simple movement test called the Get Up and Go test, where you are unable to stand up from a chair, walk a short distance, turn around, walk back, and sit down again in less than 20 seconds

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria have been provided for this clinical trial in the available information
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Investigated drugs

Erector Spinae Plane Block is a type of nerve block injection used to reduce pain. In this trial, it is being tested to see if it can help people with low back pain feel better and move around more easily. The injection is given near the muscles along the spine to block pain signals in that area.

What is already known about the treatment

Erector Spinae Plane Block – This is a pain relief procedure where local anesthetic medication is injected near the muscles along the spine to block pain signals in a specific area of the back. The technique is currently being studied in clinical trials to evaluate its effectiveness for treating sudden lower back pain that doesn't have a clear cause, such as a specific injury or disease. The procedure works by delivering numbing medication to the space around the erector spinae muscles, which temporarily stops pain nerves in that region from sending pain messages to the brain, while also helping patients move more easily right after treatment. This approach belongs to the category of regional anesthesia techniques, which numb specific parts of the body without affecting consciousness.

Investigated diseases

Acute Low Back Pain – Acute low back pain is a sudden onset of discomfort or pain in the lower region of the back, typically lasting less than six weeks. The pain is located between the lower rib cage and the buttocks and may vary in intensity from mild to severe. This condition often occurs without a specific identifiable cause, which is referred to as non-specific low back pain. The pain can make movement difficult and may worsen with certain activities such as bending, lifting, or changing positions. It commonly affects daily activities including walking, standing, and sitting for extended periods. The condition may also impact sleep quality and the ability to perform routine tasks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511595-32-00Protocol codeRECHMPL23_0409Estimated enrolment300 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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