Failed Epidural Analgesia, Post-partum Recovery
Conditions
Keywords
Labor analgesia, intrapartum cesarean delivery, failed epidural analgesia, breakthrough pain, epidural catheter re-siting, ObsQoR-10
Brief summary
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.
Interventions
OTHERNo Intervention: Observational Cohort
No intervention: observational study
Sponsors
Nicolas Brogly
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parturient who requests epidural analgesia for labor
Exclusion criteria
* Age under 18 years * Stillbirth * Continuous spinal anesthesia * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failed epidural analgesia during labor | 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
| Measure | Time frame | Description |
|---|---|---|
| Failed onset of epidural block | 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. |
| Failed conversion of epidural analgesia to anesthesia for intrapartum cesarean birth | 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. |
| Maternal recovery until 48h postpartum | 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. |
Countries
Spain
Contacts
CONTACTNicolas Brogly, MD, PhD
CONTACTFrancisco Galván-Román, MD
Outcome results
None listed