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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522071-28-00
Acronym
EpiLow
Enrollment
534
Registered
2025-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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).

Detailed description

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)., 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)., 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)., 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., 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., 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).

Interventions

DRUGLevobupivacaína NORMON 0
DRUG625 mg/ml solución para perfusión EFG
DRUGLevobupivacaína NORMON 1
DRUG25 mg/ml solución para perfusión EFG

Sponsors

Hospital Universitario La Paz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)., 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)., 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)., 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 minute

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026