AuthorisedTherapeutic use (Phase IV)Interventional

Eficacy of epidural analgesia initiated with dural puncture epidural technic for labour with ultra-low concentration of levobupivacaine 0.0625% (walking epidural). Impact on anaesthetic and obstetric outcomes.

This study is a look at a specific type of pain relief for women in labour called an 'epidural'. We're focusing on a method where the epidural is started in a particular way, using a very low dose of pain medication. This is sometimes called a 'walking epidural' because the aim is for you to be able to move around gently during labour. The main goal is to see how effectively this pain relief works and how it affects things like your pain levels, your ability to move, and the overall birth experience. We're also checking on the baby's health.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital Universitario La Paz

Enrolment target

534

Start

29 Aug 2025

Pregnant women who enter in the delivery room and request epidural analgesia for labour

What is this study about?

When you're in labour and decide you'd like pain relief, an epidural is a common choice. This study is exploring a specific way to give an epidural, using a technique called a 'dural puncture epidural'. It involves starting the epidural in a particular manner and then using a very low dose of a medication called levobupivacaine. The idea behind using a very low dose is to relieve your pain effectively while still allowing you to have some sensation and potentially move your legs, so it's sometimes referred to as a 'walking epidural'.

The main thing we want to find out is how well this low-dose epidural manages your pain. We'll be asking about your pain levels after the epidural is put in. We also want to understand how this method impacts your birthing experience, such as whether you can change positions, move around, and your overall satisfaction with the pain relief. We'll be looking at things like the type of birth you have and if there are any complications.

Finally, we'll also be checking on your baby's health. This includes looking at their condition shortly after birth and checking some measures from their umbilical cord blood. Ultimately, this study aims to gather more information about how this specific epidural technique and low-dose medication affect both the birthing mother and her baby.

Key takeaways

This study is about a specific epidural technique for pain relief during labour.
It uses a very low dose of medication, aiming for pain relief and some ability to move (a 'walking epidural').
Researchers will check how well pain is managed and how it affects your movement during labour.
They will also look at your overall birth experience and your baby's health.
The study aims to understand the impact of this method on both mother and baby.

Who may be eligible?

This study is for pregnant women who are admitted to the delivery room and have asked for an epidural to help with pain during labour.

You need to be at least 18 years old to take part in this study. There's no upper age limit, meaning if you're over 18, you can be considered.

Essentially, if you're an adult woman going into labour and planning to have an epidural, you might be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant and in labour?
Are you asking for an epidural for pain relief?
Are you 18 years old or older?
Are you able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you take part, the study will involve observing how well your epidural works using this specific method. You will have the epidural as planned for your labour. We will ask you about your pain levels at different times using a simple scale (like 0 to 10). We will also check how much you can move your legs and how often you change position or walk around. The study will look at your overall satisfaction with the pain relief you receive. We'll also record information about your delivery, such as the type of birth you have, and monitor your baby's health after birth. There will be no extra visits or special medications beyond what would be part of your normal care plan for this type of epidural and childbirth.

Potential risks and benefits

Participating in this study means you'll receive the specific epidural technique and low-dose medication being investigated, which aims to provide effective pain relief while potentially allowing more mobility. However, as with any medical procedure, there are potential risks associated with epidurals, such as a drop in blood pressure, headache, or, very rarely, nerve damage. You will be closely monitored by medical staff throughout. You are free to withdraw from the study at any time without affecting your care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a 'walking epidural'?

A 'walking epidural' uses a lower dose of pain medicine, which might allow you to have some feeling in your legs and move around more while still getting excellent pain relief.

Will I have to take extra medication?

No, you'll receive the standard medications used for this type of epidural, but it's the specific low-dose pain relief that's being studied.

Will this change my birth plan?

The study aims to see how this epidural method works within your labour; it shouldn't drastically change your overall birth plan or the care you receive.

How will my baby be checked?

Your baby's health will be checked after birth, including their general condition and some blood tests from the umbilical cord, which is standard procedure.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any point, and it won't affect the medical care you receive for your labour and birth.