Failed Epidural AnalgesiaFEA25NCT07473609
Failing Epidural Analgesia During Labor
An observational study of Failed Epidural Analgesia and Post-partum Recovery, run by Nicolas Brogly at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Failed Epidural Analgesia, Post-partum Recovery
- How many people
- 500 participants
- Where
- 2 sitesSpain
- Study dates
- 12 Jan 2026to 12 Feb 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Parturient who requests epidural analgesia for labor
Who cannot join
- Age under 18 years
- Stillbirth
- Continuous spinal anesthesia
- Refusal to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Francisco Galván-Román, MD, +34 691246504, franciscojesus.galvan@salud.madrid.org
- Not yet recruiting
Hospital Universitario La Paz
Madrid
Isabel Valbuena Gómez, MD, PhD, +34 619416458, isa_valbuena_gomez@hotmail.com
About this study
Official title: Analysis of the Incidence and Risk Factors of Epidural Analgesia Failure During Labor: A Prospective Multicenter Observational Study
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.
- Conditions
- Failed Epidural Analgesia, Post-partum Recovery
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Labor analgesia, intrapartum cesarean delivery, failed epidural analgesia, breakthrough pain, epidural catheter re-siting, ObsQoR-10
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention: observational study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start12 Jan 2026
- Primary completion31 Jul 2026
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Failed Epidural AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Nicolas Brogly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas Brogly, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473609
- Sponsor's protocol ID
- FEA25
- Other IDs
- Contract # 25/26
- Acronym
- FEA25
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not considered in the design of the research.
Publications
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.
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.
PubMed 22735301Ministerio de Sanidad. Atención perinatal en España: Análisis de los recursos físicos, humanos, actividad y calidad de los servicios hospitalarios, 2010-2018 [Publicación en Internet]. Madrid. Ministerio de Sanidad, 2021.
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/
Braithwaite J, Herkes J, Ludlow K, Testa L, Lamprell G. Association between organisational and workplace cultures, and patient outcomes: systematic review. BMJ Open. 2017 Nov 8;7(11):e017708. doi: 10.1136/bmjopen-2017-017708.
PubMed 29122796Guevara J, Sanchez C, Organista-Montano J, Domingue BW, Guo N, Sultan P. Development and validation of a Spanish version of the Obstetric Quality of Recovery-10 item score (ObsQoR-10-Spanish). BJA Open. 2024 Mar 21;10:100269. doi: 10.1016/j.bjao.2024.100269. eCollection 2024 Jun.
PubMed 38560622Sultan P, George R, Weiniger CF, El-Boghdadly K, Pandal P, Carvalho B; CRADLE Study Investigators. Expert Consensus Regarding Core Outcomes for Enhanced Recovery after Cesarean Delivery Studies: A Delphi Study. Anesthesiology. 2022 Aug 1;137(2):201-211. doi: 10.1097/ALN.0000000000004263.
PubMed 35511169Handelzalts JE, Levy S, Krissi H, Peled Y. Epidural analgesia associations with depression, PTSD, and bonding at 2 months postpartum. J Psychosom Obstet Gynaecol. 2022 Dec;43(4):488-494. doi: 10.1080/0167482X.2022.2081146. Epub 2022 Jun 28.
PubMed 35762178Ghanbari-Homaie S, Jenani SP, Faraji-Gavgani L, Hosenzadeh P, Rezaei M. Association between epidural analgesia and postpartum psychiatric disorders: A meta-analysis. Heliyon. 2024 Mar 8;10(6):e27717. doi: 10.1016/j.heliyon.2024.e27717. eCollection 2024 Mar 30.
PubMed 38524559Hernandez-Martinez A, Rodriguez-Almagro J, Molina-Alarcon M, Infante-Torres N, Rubio-Alvarez A, Martinez-Galiano JM. Perinatal factors related to post-traumatic stress disorder symptoms 1-5 years following birth. Women Birth. 2020 Mar;33(2):e129-e135. doi: 10.1016/j.wombi.2019.03.008. Epub 2019 Apr 4.
PubMed 30954482Hernandez-Martinez A, Rodriguez-Almagro J, Molina-Alarcon M, Infante-Torres N, Donate Manzanares M, Martinez-Galiano JM. Postpartum post-traumatic stress disorder: Associated perinatal factors and quality of life. J Affect Disord. 2019 Apr 15;249:143-150. doi: 10.1016/j.jad.2019.01.042. Epub 2019 Feb 10.
PubMed 30772741Gastaldon C, Solmi M, Correll CU, Barbui C, Schoretsanitis G. Risk factors of postpartum depression and depressive symptoms: umbrella review of current evidence from systematic reviews and meta-analyses of observational studies. Br J Psychiatry. 2022 Oct;221(4):591-602. doi: 10.1192/bjp.2021.222.
PubMed 35081993Orbach-Zinger S, Heesen M, Grigoriadis S, Heesen P, Halpern S. A systematic review of the association between postpartum depression and neuraxial labor analgesia. Int J Obstet Anesth. 2021 Feb;45:142-149. doi: 10.1016/j.ijoa.2020.10.004. Epub 2020 Oct 17.
PubMed 33221120Li B, Tang X, Wang T. Neuraxial analgesia during labor and postpartum depression: Systematic review and meta-analysis. Medicine (Baltimore). 2023 Feb 22;102(8):e33039. doi: 10.1097/MD.0000000000033039.
PubMed 36827052Mo J, Ning Z, Wang X, Lv F, Feng J, Pan L. Association between perinatal pain and postpartum depression: A systematic review and meta-analysis. J Affect Disord. 2022 Sep 1;312:92-99. doi: 10.1016/j.jad.2022.06.010. Epub 2022 Jun 15.
PubMed 35716784