Clinical Trial

Simulation-Based Training for Epidural Analgesia Placement

Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-28.
Status change: Not Yet Recruiting → Recruiting 2025-09-12
Trial Details
NCT Number NCT07056140
Lead Sponsor University of Padova
Conditions Epidural Analgesia, Medical Education, Obstetric Anesthesia
Enrollment 86 participants
Start Date 2025-09-12
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-09-15