Eficacy of epidural analgesia initiated with dural puncture epidural technic for labour with ultra-low concentration of levobupivacaine.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario La Paz

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-08-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 6

1. To evaluate the efficacy of analgesia using the epidural dural puncture (DPE) technic with an ultra-low concentration of local anaesthetic (LA) (levobupivacaine 0.0625%, Walking Epidural) compared to a low concentration (levobupivacaine 0.125%) in terms of the number of boosters required and epidural analgesia failure iin terms of breakthrough pain episodes.
2. To evaluate the incidence of failure to convert from labour epidural analgesia to intrapartum caesarean epidural anaesthesia requiring a new anaesthetic technique. Failure to convert to caesarean epidural anaesthesia is defined as: an anaesthetic level below T6 or lateralization of sensory block that prevents the procedure from continuing 20 minutes after the administration of a booster.
3. To analyse whether reducing epidural LA concentration has any benefit on neonatal outcomes: APGAR, umbilical cord lactic acid, and incidence of NICU admission.
4. To evaluate the influence of minor motor block on the delivery pathway (incidence of normal births, instrumental births, and caesarean sections).
5. To assess maternal satisfaction, the incidence of prolonged epidural blockade >24 hours, and the incidence of urinary retention.
6. Evaluate the effectiveness of analgesia between both groups at different time points by comparing the mean VAS scores at those points.

Conditions and MedDRA coding

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

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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).
2. Able to provide written informed consent, or have a legal representative who can provide it.
3. Able to understand the nature of the study and related procedures, as well as to comply with them.
4. Freely accepts participation in the study and gives written informed consent obtained in accordance with international guidelines and local legislation.

Exclusion criteria 9

1. Second parturients or history of more vaginal deliveries.
2. Any other condition that, in the opinion of the investigator, may interfere with the evaluation of the results of the study.
3. IMC >40 kg/m2.
4. Contraindications for the epidural technique (neurological pathology, hemostasis alterations, refusal of the patient to receive epidural analgesia).
5. Accidental dural puncture.
6. The patient presents any condition or situation that prevents or interferes with compliance with the study protocol.
7. The patient has a significant underlying disease that, in the opinion of the investigator, could prevent or alter her participation in the study.
8. Any other condition that, in the opinion of the researcher, may interfere with the evaluation of the results of the study.
9. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Presence of incomplete sensory block, defined as a Visual Analogue Scale (VAS) score greater than 3 (VAS >3) at 45 minutes after the initiation of epidural analgesia. This will be recorded as a dichotomous variable (Yes/No).

Secondary endpoints 6

1. Pain assessment through comparison of mean VAS scores: before performing the technique, at 30 minutes, 60 minutes, during the expulsive phase, and prior to manual epidural reinforcement. (Score 0–10: 0–4 cm mild pain; 5–7 cm moderate pain; 8–10 cm severe pain).
2. Epidural analgesia failure requiring the performance of a new technique (new technique: Yes/No). Incidence of failure in the conversion from epidural analgesia to epidural anesthesia for intrapartum cesarean section, requiring a new technique, either neuraxial or general anesthesia (failure: Yes/No; new technique: Yes/No; type: sedation, spinal, epidural, combined, general anesthesia).
3. APGAR at 1 minute and 5 minutes (whole numbers from 1-10) pH in cord blood (number) Lactic acid in cord blood (mmol/L) Admission to NICU (Y/N).
4. Assessment of motor block using the Bromage scale at 30 minutes, 60 minutes and expulsion, and Bromage prior to manual epidural reinforcement. Frequency of postural changes and ambulation time in minutes. Type of delivery. Indication of caesarean section if necessary and degree of urgency according to Lucas classification.
5. Degree of satisfaction using the BSS-RI scale (Birth Satisfaction Scale-Revised Indicator, score 0-12, attached document). Prolonged epidural block >24h (hours). Urinary retention. Other complications.
6. Number of epidural boluses administered via PCEA (Patient Controlled Epidural Analgesia) and manually requested (in whole numbers: 1, 2, 3…). Failure of PCEA reinforcement (Yes/No). Episodes of breakthrough pain, defined as VAS >3, prior to achieving adequate epidural analgesia, requiring manual reinforcement (in whole numbers: 1, 2, 3…). Administration of paracetamol (Yes/No).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario La Paz

Sponsor organisation

Hospital Universitario La Paz

Address

Paseo De La Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Hospital Universitario La Paz

Contact name

Isabel Valbuena Gómez

Public contact point

Organisation

Hospital Universitario La Paz

Contact name

Isabel Valbuena Gómez

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications