Failing Epidural Analgesia During Labor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNicolas Brogly
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parturient who requests epidural analgesia for labor
Disqualifiers
Age under 18 years
Stillbirth
Continuous spinal anesthesia
Refusal to participate
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention: observational study
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Labor Epidural Analgesia1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicolas Brogly
Lead sponsor
Hospital General Universitario Gregorio Marañon
Sponsor institution
Source ClinicalTrials.gov