An observational study in Failed Epidural Analgesia and Post-partum Recovery, sponsored by Nicolas Brogly. Recruiting at 2 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Nicolas Brogly · Observational
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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's planned enrollment of 500 is above the median of 125 across 10 observational studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Nicolas Brogly is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort of consecutive consenting patients admitted in the labor ward for delivery of two tertiary university hospitals in Madrid-Spain for a period of 1 month, which each center chooses throughout 2026.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Inclusion criteria: all consecutive patients in labor who request epidural analgesia for labor analgesia in the period of recruitment. Exclusion criteria: parturient age under 18 years; stillbirth; continuous spinal anesthesia; refusal to participate
Other: No Intervention: Observational Cohort
No intervention: observational study
Failed epidural analgesia during labor
Persistence of pain 20 minutes after one top-up bolus of local anesthetic administered by the anesthesiologist, in a previously working epidural analgesia.
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.
Failed onset of epidural block
Absence or insufficient epidural block in level and/or density in the first 30 minutes after the administration of the induction bolus.
Time frame: An incomplete or inefficient block 30 minutes after initiation of epidural analgesia will be considered as a failed onset.
Failed conversion of epidural analgesia to anesthesia for intrapartum cesarean birth
Requirement for a new regional block, intravenous supplementation or general anesthesia for an intrapartum cesarean birth in a patient with labor epidural analgesia.
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.
Maternal recovery until 48h postpartum
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.
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).
Plan to share: No — This was not considered in the design of the research.
Ran from Jan 2026 to primary completion in Jul 2026, 6 months.
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Nicolas Brogly