Misslyckad epiduralanalgesi under förlossning (FEA25)
15 september 2026 uppdaterad av: Nicolas Brogly
Analys av förekomst och riskfaktorer för misslyckad epiduralanalgesi under förlossning: En prospektiv multicenterobservationsstudie
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
500
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Nicolas Brogly, MD, PhD
- Telefonnummer: +34 663676820
- E-post: nicolas.brogly@salud.madrid.org
Studera Kontakt Backup
- Namn: Francisco Galván-Román, MD
- Telefonnummer: +34 691246504
- E-post: franciscojesus.galvan@salud.madrid.org
Studieorter
-
-
-
Madrid, Spanien, 28007
- Rekrytering
- Hospital General Universitario Gregorio Marañón
-
Kontakt:
- Francisco Galván-Román, MD
- Telefonnummer: +34 691246504
- E-post: franciscojesus.galvan@salud.madrid.org
-
Madrid, Spanien
- Har inte rekryterat ännu
- Hospital Universitario La Paz
-
Kontakt:
- Isabel Valbuena Gómez, MD, PhD
- Telefonnummer: +34 619416458
- E-post: isa_valbuena_gomez@hotmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- Parturient who requests epidural analgesia for labor
Exclusion Criteria:
- Age under 18 years
- Stillbirth
- Continuous spinal anesthesia
- Refusal to participate
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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 |
No intervention: observational study |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Failed epidural analgesia during labor
Tidsram: 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. |
All duration of labour (from admission to labour ward until delivery) in patients with an initial adequate pain relief after epidural analgesia initiation.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Failed onset of epidural block
Tidsram: 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. |
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
Tidsram: 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. |
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
Tidsram: 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:
|
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).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Thangamuthu A, Russell IF, Purva M. Epidural failure rate using a standardised definition. Int J Obstet Anesth. 2013 Nov;22(4):310-5. doi: 10.1016/j.ijoa.2013.04.013. Epub 2013 Aug 6.
- Rajagopalan S, Shah K, Guffey D, Tran C, Suresh M, Wali A. Predictors of difficult epidural placement in pregnant women: A trainees' perspective. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):548-552. doi: 10.4103/joacp.JOACP_340_18.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stav MY, Fein S, Matatov Y, Hoffman D, Heesen P, Binyamin Y, Iluz-Freundlich D, Eidelman L, Orbach-Zinger S. Conversion to general anesthesia and intravenous supplementation during intrapartum cesarean delivery with an indwelling epidural catheter: a retrospective study. Reg Anesth Pain Med. 2025 Nov 5;50(11):873-878. doi: 10.1136/rapm-2024-105388.
- Grap SM, Patel GR, Huang J, Vaida SJ. Risk factors for labor epidural conversion failure requiring general anesthesia for cesarean delivery. J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):118-123. doi: 10.4103/joacp.JOACP_192_20. Epub 2021 Oct 13.
- Brogly N, Valbuena Gomez I, Afshari A, Ekelund K, Kranke P, Weiniger CF, Lucas N, Dewandre PY, Guasch Arevalo E, Ioscovich A, Kollmann A, Lindelof K, Orbach-Zinger S, Reis S, van den Bosch O, Van de Velde M, Romero CS. ESAIC focused guidelines for the management of the failing epidural during labour epidural analgesia. Eur J Anaesthesiol. 2025 Feb 1;42(2):96-112. doi: 10.1097/EJA.0000000000002108. Epub 2025 Jan 2.
- Berger AA, Jordan J, Li Y, Kowalczyk JJ, Hess PE. Epidural catheter replacement rates with dural puncture epidural labor analgesia compared with epidural analgesia without dural puncture: a retrospective cohort study. Int J Obstet Anesth. 2022 Nov;52:103590. doi: 10.1016/j.ijoa.2022.103590. Epub 2022 Aug 2.
- Wang L, Huang J, Chang X, Xia F. Effects of different neuraxial analgesia modalities on the need for physician interventions in labour: A network meta-analysis. Eur J Anaesthesiol. 2024 Jun 1;41(6):411-420. doi: 10.1097/EJA.0000000000001986. Epub 2024 Mar 28.
- Tan HS, Zeng Y, Qi Y, Sultana R, Tan CW, Sia AT, Sng BL, Siddiqui FJ. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD011344. doi: 10.1002/14651858.CD011344.pub3.
- Tan HS, Liu N, Tan CW, Sia ATH, Sng BL. Developing the BreakThrough Pain Risk Score: an interpretable machine-learning-based risk score to predict breakthrough pain with labour epidural analgesia. Can J Anaesth. 2022 Oct;69(10):1315-1317. doi: 10.1007/s12630-022-02294-1. Epub 2022 Aug 5. No abstract available.
- Tan HS, Liu N, Sultana R, Han NR, Tan CW, Zhang J, Sia ATH, Sng BL. Prediction of breakthrough pain during labour neuraxial analgesia: comparison of machine learning and multivariable regression approaches. Int J Obstet Anesth. 2021 Feb;45:99-110. doi: 10.1016/j.ijoa.2020.08.010. Epub 2020 Aug 25.
- Guasch E, Iannuccelli F, Brogly N, Gilsanz F. Failed epidural for labor: what now? Minerva Anestesiol. 2017 Nov;83(11):1207-1213. doi: 10.23736/S0375-9393.17.12082-1. Epub 2017 Jun 12.
- Bucstain C, Garmi G, Zafran N, Zuarez-Easton S, Carmeli J, Salim R. Risk factors and peripartum outcomes of failed epidural: a prospective cohort study. Arch Gynecol Obstet. 2017 May;295(5):1119-1125. doi: 10.1007/s00404-017-4337-5. Epub 2017 Mar 10.
- Agaram R, Douglas MJ, McTaggart RA, Gunka V. Inadequate pain relief with labor epidurals: a multivariate analysis of associated factors. Int J Obstet Anesth. 2009 Jan;18(1):10-4. doi: 10.1016/j.ijoa.2007.10.008. Epub 2008 Nov 28.
- Ezeonu PO, Anozie OB, Onu FA, Esike CU, Mamah JE, Lawani LO, Onoh RC, Ndukwe EO, Ewah RL, Anozie RO. Perceptions and practice of epidural analgesia among women attending antenatal clinic in FETHA. Int J Womens Health. 2017 Dec 12;9:905-911. doi: 10.2147/IJWH.S144953. eCollection 2017.
- Sisman Y, Ekelund K, Strandbygaard J. [Failed epidural analgesia during birth]. Ugeskr Laeger. 2019 Apr 15;181(16):V09180650. Danish.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 januari 2026
Primärt slutförande (Faktisk)
31 juli 2026
Avslutad studie (Beräknad)
12 februari 2027
Studieregistreringsdatum
Först inskickad
24 februari 2026
Först inskickad som uppfyllde QC-kriterierna
12 mars 2026
Första postat (Faktisk)
16 mars 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FEA25
- Contract # 25/26 (Annan identifierare: FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA HOSPITAL GREGORIO MARAÑÓN)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
This was not considered in the design of the research.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .