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A Study Testing Erector Spinae Plane Block with Ropivacaine versus Placebo for Pain Relief in Adults with Acute Kidney Stone Pain in the Emergency Department

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What is this trial about?

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

This study examines urolithiasis, which is a condition where stones form in the urinary system, particularly in the kidneys, causing severe pain known as renal colic. When these stones cause sudden and intense pain, patients often visit the emergency department for treatment. The study will test whether a pain control method called an Erector Spinae Plane Block can help manage this type of pain better. This method involves injecting a pain-relieving medication near the spine to block pain signals. The study will compare two treatments: one group will receive an injection with ropivacaine hydrochloride, which is a local pain-blocking medication, while the other group will receive an injection with a solution containing sodium chloride and potassium chloride, which are salts commonly found in the body. Both injections will be given in a similar way so that neither the patients nor the doctors know which treatment is being given until after the study is completed.

The purpose of the study is to find out if the spine block method is effective in reducing pain for patients with kidney stones, and whether it can improve patient satisfaction and reduce the need for hospital stays or additional procedures. The study will also look at whether this treatment can lower the amount of additional pain medication needed and reduce side effects from pain medications. After the initial treatment in the emergency department, patients will be asked about their pain levels at different times over the first 24 hours, and then again at seven days and one month later. The study will measure pain intensity, how much the pain interferes with daily activities, quality of life, and whether patients need to return to the emergency department or require surgery for their kidney stones.

During the study, patients will complete questionnaires about their pain, how it affects their daily activities, their overall well-being, and their satisfaction with the treatment. The study will track whether patients need to be admitted to the hospital, whether they require procedures to remove or break up the stones, and how much additional pain medication they use. The study will also monitor for any complications related to the treatment and will assess whether patients develop ongoing pain problems one month after receiving the treatment. Information about healthcare costs and time away from work will also be collected to understand the overall impact of the treatment.

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

    Initial assessment and confirmation

    After arriving at the Emergency Department with kidney stone pain, an ultrasound or CT scan will be performed to confirm the presence of a kidney stone (urolithiasis).

    Initial pain medication will be administered.

    If pain remains at a level of 4 or higher on a scale from 0 to 10 after the scan confirmation and initial medication, eligibility for the study will be assessed.

  2. Step 2

    Baseline pain assessment

    Pain level will be measured using a pain rating scale from 0 to 10.

    A questionnaire called the Brief Pain Inventory Short Form will be completed to assess current pain intensity and how pain interferes with daily activities.

    Quality of life will be assessed using the EQ-5D-5L questionnaire.

  3. Step 3

    Treatment administration

    One of two treatment approaches will be assigned: either standard pain management or standard pain management combined with an Erector Spinae Plane Block.

    The Erector Spinae Plane Block is a procedure where pain-relieving medication is injected near the spine to numb the affected area.

    If assigned to receive the block, the procedure will involve an injection containing ropivacaine hydrochloride (a local numbing medication) and sodium chloride solution.

  4. Step 4

    Short-term pain monitoring

    Pain levels will be checked at 30 minutes after the treatment.

    Pain levels will be checked again at 60 minutes after the treatment.

    Additional pain measurements will be taken at 6 hours and 12 hours after the treatment, but only while awake.

    Any additional pain medication needed during this time will be recorded.

  5. Step 5

    24-hour follow-up

    At 24 hours after treatment, pain intensity and interference will be assessed again using the Brief Pain Inventory Short Form.

    The time when first additional pain medication was needed will be documented.

    Total amount of additional pain medication used in the first 24 hours will be recorded.

    Any side effects from pain medication will be evaluated using the Overall Benefit of Analgesia Score.

    Patient satisfaction will be measured using the Patient Global Impression of Change questionnaire, which asks about overall improvement.

  6. Step 6

    Seven-day follow-up

    At seven days after treatment, quality of life will be assessed again using the EQ-5D-5L questionnaire.

    Patient satisfaction will be measured again using the Patient Global Impression of Change questionnaire.

    Information will be collected about any hospital admissions on the same day as the initial visit.

    Information will be collected about any urologic procedures performed within the seven days.

    Any return visits to the Emergency Department related to kidney stone pain will be documented.

    Healthcare costs and work productivity will be assessed using shortened questionnaires about medical care received and time off work.

  7. Step 7

    One-month follow-up

    At one month after treatment, the Brief Pain Inventory Short Form will be completed again to check for ongoing pain.

    Quality of life will be assessed once more using the EQ-5D-5L questionnaire.

    Healthcare costs and work productivity will be assessed again using the same shortened questionnaires.

    Any serious complications related to the nerve block procedure will be documented, including infection, bleeding, or other adverse events.

Who can join the trial?

4 criteria

  • You must be 18 years of age or older
  • You must be able and willing to sign a form agreeing to take part in the study, which is called informed consent
  • You must have urolithiasis, which means kidney stones, confirmed by an ultrasound (a scan using sound waves to create pictures of the inside of your body) or a CT-scan (a special x-ray that takes detailed pictures) during your emergency department visit. The stone must be clearly visible on the scan, not just signs that suggest a stone might be present
  • You must still have ongoing pain with a score of 4 or higher on a pain scale from 0 to 10 after the scan confirms you have kidney stones and after you have already received initial pain medication

Who cannot join the trial?

2 criteria

  • The study information does not list specific reasons why patients cannot participate in this trial
  • If you have questions about whether you can join this study, you will need to discuss your individual situation with the research team during the screening process
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Investigated drugs

Erector Spinae Plane Block is a type of nerve block procedure used to help manage pain. In this treatment, medication is injected near the spine to numb the nerves in a specific area of the body. This block is being tested as an additional pain relief method for people experiencing severe kidney stone pain in the emergency department. The goal is to see if this nerve block can help reduce pain more effectively when used alongside standard pain treatments.

What is already known about the treatment

Erector Spinae Plane Block – This is a regional anesthesia technique where pain-relieving medication is injected near the spine to block pain signals from reaching the brain. The procedure involves placing local anesthetic medicine in the tissue layer surrounding the erector spinae muscles in the back, which helps numb the nerves that carry pain sensations from the kidney area. It is currently being studied as a treatment option for patients experiencing severe pain from kidney stones in emergency departments. This method works by stopping pain signals at their source before they can travel through the nervous system to be felt by the patient.

Investigated diseases

Urolithiasis – Urolithiasis is a condition where solid stones form in the urinary system, including the kidneys, ureters, bladder, or urethra. These stones develop when minerals and salts in the urine crystallize and stick together. The stones can vary in size from tiny grains to larger masses that can block the urinary passages. When a stone moves through the urinary tract, it can cause sudden and severe pain known as renal colic. This pain typically occurs in the back, side, lower abdomen, or groin area and may come in waves. The condition may also cause blood in the urine, frequent urination, and discomfort during urination.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521316-19-00Estimated enrolment160 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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