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Comparison of two concentrations of levobupivacaine (0.

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What is this trial about?

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

This clinical trial focuses on studying pain relief during childbirth using epidural analgesia in pregnant women who request pain management during labor. The study compares two different concentrations of levobupivacaine, a local anesthetic medication, using a special technique called dural puncture epidural. One group will receive a very low concentration (0.0625%) of the medication, known as a "walking epidural," while the other group will receive a higher concentration (0.125%).

The main purpose of this study is to determine how well the lower concentration of medication works in providing pain relief compared to the standard higher concentration. During the study, other medications may also be used as needed, including fentanyl for additional pain relief and ropivacaine as an alternative local anesthetic. The effectiveness of the pain relief will be measured at various times during labor.

Throughout labor, healthcare providers will monitor the mother's pain levels, ability to move, and overall comfort. They will also track how the different medication concentrations might affect the delivery process and the newborn's health. The study will evaluate patient satisfaction with the pain relief method and record any complications that may occur during or after the procedure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and pain evaluation

    Your pain level will be evaluated using a Visual Analogue Scale (VAS) where 0 means no pain and 10 means worst possible pain

    The assessment takes place before starting the pain relief procedure

  2. Step 2

    Administration of epidural analgesia

    You will receive one of two types of epidural pain relief:

    Either levobupivacaine 0.0625% (ultra-low concentration) or levobupivacaine 0.125% (low concentration)

    The medication is administered through a small tube placed in your back

  3. Step 3

    Monitoring period - first hour

    Your pain levels will be checked at 30 minutes and 45 minutes after the procedure starts

    Your ability to move will be assessed using a special scale at 30 minutes and 60 minutes

    You may have the opportunity to change positions or walk, depending on your condition

  4. Step 4

    Ongoing pain management

    You can request additional pain relief doses through a patient-controlled system

    If needed, manual reinforcement of pain relief may be provided

    Your pain levels will continue to be monitored throughout labor

  5. Step 5

    Delivery phase

    Pain levels will be assessed during the final pushing phase

    Additional pain relief may be provided if necessary

    Your satisfaction with pain relief will be evaluated after delivery using a special scale

  6. Step 6

    Post-delivery monitoring

    You will be monitored for up to 24 hours after the procedure

    Any lasting effects of the pain relief will be documented

    Any complications or side effects will be recorded

Who can join the trial?

6 criteria

  • Must be a primiparous pregnant woman (giving birth for the first time) in labor, either naturally or induced, with cervical opening of more than 3 centimeters when entering the delivery room
  • Must be able to give written permission to participate in the study, or have a legal representative who can provide this permission
  • Must be able to understand what the study involves and follow all required procedures
  • Must freely agree to participate in the study and provide written consent according to required guidelines
  • Must be a female of childbearing age
  • Must be requesting epidural analgesia (pain relief medication delivered through a small tube in the back) for labor pain management

Who cannot join the trial?

11 criteria

  • Women who are not pregnant or not in active labor
  • Women who do not request or do not want epidural analgesia (pain relief medication injected into the space around the spinal cord)
  • Women under 18 years of age
  • Women with known allergies to levobupivacaine (the local anesthetic medication used in the study)
  • Women with bleeding disorders or who are taking blood-thinning medications
  • Women with infections at the site where the epidural would be placed
  • Women with previous spine surgery that could interfere with epidural placement
  • Women with neurological conditions affecting the spine or nerves
  • Women who cannot understand or provide informed consent
  • Women with contraindications (medical reasons that make it unsafe) for epidural anesthesia
  • Male participants (as this study is specifically for pregnant women in labor)
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Investigated drugs

  • Levobupivacaine

    is a local anesthetic medication used for pain relief during labor. It is administered through an epidural technique, which involves injecting the medication into the space around the spinal cord. This medication works by blocking nerve signals that transmit pain, while allowing some movement and sensation to remain (hence the term "walking epidural"). It helps manage labor pain while potentially allowing the mother to maintain some mobility during the birthing process.

  • Dural Puncture Epidural (DPE)

    is not a medication but a specialized technique for administering epidural anesthesia. This technique involves making a tiny hole in the dural membrane (a protective layer around the spinal cord) before placing the epidural catheter. This method is designed to provide more effective pain relief while using lower doses of anesthetic medication.

What is already known about the treatment

Levobupivacaine - A long-acting local anesthetic medication administered through epidural injection during labor and childbirth, available in different concentrations including ultra-low (0.0625%) and low (0.125%) formulations. This medication works by blocking sodium channels in nerve cells, preventing the transmission of pain signals from the lower body to the brain, while allowing some motor function to remain intact (hence the term "walking epidural" for lower concentrations). As a widely used medication in obstetric anesthesia, levobupivacaine offers effective pain relief during labor with a favorable safety profile, and its ultra-low concentration formulation aims to provide adequate pain control while maintaining greater mobility for the laboring mother.

Investigated diseases

  • Labor Pain

    A physiological process occurring during childbirth when uterine contractions cause discomfort and pain. The pain typically begins in the lower back and abdomen, increasing in intensity and frequency as labor progresses. During labor, the pain pattern changes from early intermittent discomfort to more intense and regular sensations as the cervix dilates and the baby descends through the birth canal. The pain experience varies significantly among individuals, with some women experiencing mild discomfort while others report severe pain.

  • Breakthrough Pain During Labor

    A temporary increase in pain intensity that occurs despite ongoing pain management during labor. It manifests as sudden spikes of pain that break through the existing pain control measures. These episodes can occur intermittently throughout the labor process, even when baseline pain is otherwise well-managed.

  • Postpartum Urinary Retention

    A condition where a woman experiences difficulty emptying her bladder completely after childbirth. It typically develops within the first 24 hours after delivery and can persist for several days. The condition may cause discomfort, bladder distension, and a sensation of incomplete bladder emptying.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522071-28-00Protocol codeEpiLowEstimated enrolment534 patientsSponsorHospital Universitario La Paz

sourced from the EU Clinical Trials Register and site verification

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