Analysis of the Incidence and Risk Factors of Epidural Analgesia Failure During Labor: A Prospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Failed epidural analgesia during labor
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturient who requests epidural analgesia for labor
排除标准
- •Age under 18 years
- •Stillbirth
- •Continuous spinal anesthesia
- •Refusal to participate
研究组 & 干预措施
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
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Failed epidural analgesia during labor
时间窗: 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.
次要结局
- Failed onset of epidural block(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(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(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).)
研究者
Nicolas Brogly
Coordinator of failing epidural Investigation
Hospital General Universitario Gregorio Marañon