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| ID | Type | Description | Link |
|---|---|---|---|
| Contract # 25/26 | Other Identifier | FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL GREGORIO MARAÑÓN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Labor Epidural Analgesia | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention: observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | All duration of labour (from admission to labour ward until delivery) in patients with an initial adequate pain relief after epidural analgesia initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Brogly, MD, PhD | Contact | +34 663676820 | nicolas.brogly@salud.madrid.org | |
| Francisco Galván-Román, MD | Contact | +34 691246504 | franciscojesus.galvan@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | 28007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Russell I. Technique of anaesthesia for caesarean section. In: Colvin J, editor. Raising the Standard: A Compendium of Audit Recipes for Continuous Quality Improvement in Anaesthesia. 2nd ed. London: RCA; 2006. p. 166-7. | ||
| 22735301 | Background | Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144-54. doi: 10.1093/bja/aes214. Epub 2012 Jun 26. | |
| Background | Ministerio de Sanidad. Atención perinatal en España: Análisis de los recursos fÃsicos, humanos, actividad y calidad de los servicios hospitalarios, 2010-2018 [Publicación en Internet]. Madrid. Ministerio de Sanidad, 2021. | ||
| Background | WFSA recommendations: Declaration on Labour Analgesia: A Call for Global Access to Pain Relief During Childbirth; 2025. https://wfsahq.org/our-work/advocacy/campaigns/labour-analgesia-campaign/ |
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This was not considered in the design of the research.
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| ID | Term |
|---|---|
| D059390 | Breakthrough Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Requirement for a new regional block, intravenous supplementation or general anesthesia for an intrapartum cesarean birth in a patient with labor epidural analgesia. |
| 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:
| 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). |
| Hospital Universitario La Paz | Not yet recruiting | Madrid | Spain |
|
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