Comparison of two concentrations of levobupivacaine (0.

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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)

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fichvdcqg Pnux Lz Iawalhdggmqrv Bhwqowicw Die Hgxovrst Ucrzqsxepkmrn Lr Pid	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.11.2025

Trial locations

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.

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 ID:

2025-522071-28-00

Protocol code:

EpiLow

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of two concentrations of levobupivacaine (0.

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