AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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.

Nicolas Brogly, MD, PhD contact

+34 663676820

nicolas.brogly@salud.madrid.org

Francisco Galván-Román, MD contact

+34 691246504

franciscojesus.galvan@salud.madrid.org

Spain2 sites, 2 recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

    Francisco Galván-Román, MD, +34 691246504, franciscojesus.galvan@salud.madrid.org

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Isabel Valbuena Gómez, MD, PhD, +34 619416458, isa_valbuena_gomez@hotmail.com

    Not yet recruiting

Other trials in Spain

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.

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 groups in NCT07473609
Study groupRoleWhat they receive
Labor Epidural AnalgesiaInclusion 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.

  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.

    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)

  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.

    Measured: 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.

    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.

  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.

    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.

  1. First posted16 Mar 2026
  2. Study start12 Jan 2026
  3. Primary completion31 Jul 2026
  4. Study completion12 Feb 2027 (estimated)

Resources

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
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 22735301

  • Ministerio 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 29122796

  • Guevara 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 38560622

  • Sultan 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 35511169

  • Handelzalts 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 35762178

  • Ghanbari-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 38524559

  • Hernandez-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 30954482

  • Hernandez-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 30772741

  • Gastaldon 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 35081993

  • Orbach-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 33221120

  • Li 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 36827052

  • Mo 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

Questions about this trial

What is this clinical trial studying?

An observational study of Failed Epidural Analgesia and Post-partum Recovery, run by Nicolas Brogly at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolas Brogly, MD, PhD (+34 663676820, nicolas.brogly@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failed epidural analgesia during labor (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07473609, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in