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Eficacy of epidural analgesia initiated with dural puncture epidural technic for labour with ultra-low concentration of levobupivacaine.
EU CTIS ID: 2025-522071-28-00
What this study is testing
To evaluate the efficacy of analgesia using the epidural technique with dural technic puncture (DPE) with an ultra-low concentration of local anaesthetic (LA) (levobupivacaine 0.0625%, Walking Epidural) compared with the low concentration (levobupivacaine 0.125%) in terms of incomplete sensory block.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Primiparous pregnant women in labor either spontaneously or by induction of labor, presenting in both cases cervical dilatation > 3 cm upon admission to the dilatation room (1st active phase of labor).
- Able to provide written informed consent, or have a legal representative who can provide it.
- Able to understand the nature of the study and related procedures, as well as to comply with them.
- Freely accepts participation in the study and gives written informed consent obtained in accordance with international guidelines and local legislation.
You likely can't join if
- Second parturients or history of more vaginal deliveries.
- Any other condition that, in the opinion of the investigator, may interfere with the evaluation of the results of the study.
- IMC >40 kg/m2.
- Contraindications for the epidural technique (neurological pathology, hemostasis alterations, refusal of the patient to receive epidural analgesia).
- Accidental dural puncture.
- The patient presents any condition or situation that prevents or interferes with compliance with the study protocol.
See the full eligibility criteria
- Primiparous pregnant women in labor either spontaneously or by induction of labor, presenting in both cases cervical dilatation > 3 cm upon admission to the dilatation room (1st active phase of labor).
- Able to provide written informed consent, or have a legal representative who can provide it.
- Able to understand the nature of the study and related procedures, as well as to comply with them.
- Freely accepts participation in the study and gives written informed consent obtained in accordance with international guidelines and local legislation.
- Second parturients or history of more vaginal deliveries.
- Any other condition that, in the opinion of the investigator, may interfere with the evaluation of the results of the study.
- IMC >40 kg/m2.
- Contraindications for the epidural technique (neurological pathology, hemostasis alterations, refusal of the patient to receive epidural analgesia).
- Accidental dural puncture.
- The patient presents any condition or situation that prevents or interferes with compliance with the study protocol.
- The patient has a significant underlying disease that, in the opinion of the investigator, could prevent or alter her participation in the study.
- Any other condition that, in the opinion of the researcher, may interfere with the evaluation of the results of the study.
- Pregnant women who do not achieve a sufficient level of analgesia and experience epidural analgesia failure 50 minutes after the initiation of the technique, due to the absence of any sensory and/or motor block or its lateralization, secondary to incorrect catheter placement outside the epidural space or laterally within it, requiring a new neuraxial technique.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.