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NCT Number: NCT07473609

Failing Epidural Analgesia During Labor

This prospective multicenter observational study is being conducted at the Gregorio Marañón University General Hospital and the La Paz University Hospital in Madrid, Spain. The recruitment period began on January 12, 2026, and will continue until February 12, 2027. Patients over 18 years of age requesting epidural analgesia for labor are included. Exclusion criteria are: age under 18; stillbirth; continuous spinal anesthesia; refusal to participate in the study. The primary objective of the study is to calculate the incidence of epidural analgesia failure during labor. Secondary objectives are: identification of potential risk factors for epidural analgesia failure; failure of epidural anesthesia for emergency cesarean birth; maternal postpartum recovery at 24 and 48 hours using the Spanish-validated version of ObsQoR-10 questionnaire.

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Key information

Conditions

Failed Epidural Analgesia Breakthrough Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-partum Recovery Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital General Universitario Gregorio Marañón, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturient who requests epidural analgesia for labor

Exclusion criteria

  • Age under 18 years
  • Stillbirth
  • Continuous spinal anesthesia
  • Refusal to participate

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention: observational study

Primary outcomes

  1. Failed epidural analgesia during labor

    Time frame: All duration of labour (from admission to labour ward until delivery) in patients with an initial adequate pain relief after epidural analgesia initiation.

    Persistence of pain 20 minutes after one top-up bolus of local anesthetic administered by the anesthesiologist, in a previously working epidural analgesia.

Secondary outcomes

  1. Failed onset of epidural block

    Time frame: An incomplete or inefficient block 30 minutes after initiation of epidural analgesia will be considered as a failed onset.

    Absence or insufficient epidural block in level and/or density in the first 30 minutes after the administration of the induction bolus.

  2. Failed conversion of epidural analgesia to anesthesia for intrapartum cesarean birth

    Time frame: In subpopulation of patients with an intrapartum cesarean delivery, failed conversion will be considered for any requirement for intravenous supplementation or general anaesthesia during caesarean delivery.

    Requirement for a new regional block, intravenous supplementation or general anesthesia for an intrapartum cesarean birth in a patient with labor epidural analgesia.

  3. Maternal recovery until 48h postpartum

    Time frame: On postpartum day 1 (24h after delivery) and day 2 (48h after delivery), during post-partum anaesthesia visit, the participants will answer the 10-Items Obstetric Quality of Recovery scoring tool (ObsQoR-10).

    Measurement of maternal recovery at 24 and 48 hours postpartum using the Spanish-validated version of 10-Items Obstetric Quality of Recovery scoring tool (ObsQoR-10).

    This 0-100 points score includes:

    • 4 items concerning postpartum side effects, rated from 0 to 10, with higher scores corresponding to lower intensity of side effects,
    • 6 items concerning postpartum recovery variables, rated from 0 to 10, with higher scores corresponding to better postpartum recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco Galván-Román, MD

CONTACT

[email protected]

+34 691246504

Nicolas Brogly, MD, PhD

CONTACT

[email protected]

+34 663676820

Sponsors and collaborators

Lead sponsor

Nicolas Brogly

Other

Registry information

Official study title

Analysis of the Incidence and Risk Factors of Epidural Analgesia Failure During Labor: A Prospective Multicenter Observational Study

Acronym: FEA25

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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