Effectiveness of Simulation-Based Training for Epidural Analgesia Placement in Obstetric Settings: A Prospective, Randomized, Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Success Rate of Epidural Catheter Placement
研究概览
简要总结
Epidural analgesia is the gold standard for labor pain management, widely recommended by the WHO and included in Italy's essential levels of care (LEA) since 2017. Despite its clinical benefits and high maternal satisfaction, the procedure remains technically challenging, particularly for anesthesia residents. In our institution, around 40% of laboring women request epidural analgesia.
Successful epidural placement requires mastering a complex skillset. Recent studies highlight that simulation-based training significantly enhances learning for novice practitioners. This single-center, prospective, randomized controlled trial aims to evaluate whether a pre-rotation simulator-based training improves the success rate of epidural catheter placement among anesthesia residents.
Participants will be randomly assigned to either the intervention group (simulation training plus anatomy lecture) or the control group (standard in vivo training only). The primary outcome is the number of successful catheter placements (defined as completed procedure without tutor intervention). Secondary outcomes include procedure time, complication rates, and satisfaction scores from the residents. The study will involve anesthesia residents in their 4th or 5th year rotating in the labor ward of the Azienda Ospedaliera di Padova. A sample size of 86 participants (43 per group) is required, and data collection will occur over three years.
详细描述
Epidural analgesia remains the most effective method to relieve pain during labor. It acts on both visceral and somatic pain pathways and is particularly recommended in various maternal and fetal indications, such as twin pregnancies, induced labor, and high-risk maternal conditions (e.g., obesity, preeclampsia, diabetes). Despite its widespread use, epidural placement is technically demanding, especially in laboring women who are in pain, exhausted, and often overweight.
This complexity is further compounded by the fact that fewer open surgeries are being performed in training settings, which limits residents' opportunities to practice epidural catheter placement under optimal conditions. Hence, the use of simulation-based training has become increasingly important.
The aim of this study is to assess whether prior training with high-fidelity epidural simulators improves the technical success of novice anesthesia residents. Simulation sessions will utilize models already available at the teaching center (Kyoto Kagaku Lumbar Puncture and Epidural Anesthesia Simulators).
This open-label, randomized, single-center interventional study will recruit anesthesia residents with less than 20 previous epidural placements. Residents will be allocated into two groups (simulation vs. control) and further stratified by experience level (novice <20 vs. intermediate >20 prior procedures). Those in the simulation group will receive a frontal anatomy lecture and a 3-hour practical session on simulators before their labor ward rotation.
All procedures will be performed under supervision, and outcome assessors will complete structured CRFs for each attempt. Data will be pseudonymized and stored securely. Analyses will include both parametric and non-parametric tests, with a significance level of p < 0.05. The trial complies with GCP standards and ethical guidelines, and informed consent will be obtained from all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents in Anesthesia
- •Informed Consent
排除标准
- •An experience of 20 or more epidural catheter positioning
- •Experience with epidural simulator
研究组 & 干预措施
Epidural Simulator Training Group
Participants receive training using the epidural simulator before starting their residency period and actually performing procedures on patients.
干预措施: Epidural Simulation Training (Procedure)
Epidural Simulator Training Group
Participants receive training using the epidural simulator before starting their residency period and actually performing procedures on patients.
干预措施: Standard Clinical Training (Procedure)
Traditional Training Group
Participants receive standard theorical clinical training without the use of the epidural simulator before their residency period in the obstetric unit
干预措施: Standard Clinical Training (Procedure)
结局指标
主要结局
Success Rate of Epidural Catheter Placement
时间窗: Immediately following the procedure, up to 45 minutes after the enorllment.
Defined as successful placement of the epidural catheter in the correct anatomical space as determined by supervising anesthesiologist.
次要结局
- Number of Attempts Required for Successful Placement of the Epidural Cathter(During the procedure, from the enrollment up to 45 minutes after the enorllment)
- Incidence of Accidental Dural Puncture (Complication)(During the procedure from the enrollment up to 45 minutes after the enorllment)
- Incidence of Bloody Tap (Complication)(During the procedure, from the enrollment up to 45 minutes after the enorllment)
- Incidence of Supervisor intervention(During the procedure, from the enrollment up to 45 minutes after the enorllment)
- Success Rate of Epidural Catheter Positioning During the Day Shift(During the procedure, from the enrollment up to 45 minutes after the enorllment)
- Success Rate of Epidural Catheter Positioning During the Night Shift(During the procedure, from the enrollment up to 45 minutes after the enorllment)
- Time to Complete the Epidural Catheter Positioning(From the start to the end of the procedure, from the enrollment up to 45 minutes after the enrollment)
研究者
Alessandro De Cassai
Principal Investigator
University of Padova