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Recruiting Not applicable

Simulation-Based Training for Epidural Analgesia Placement

NCT07056140 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-09-12
Last updated
2025-09-15

Condition(s) studied

Epidural AnalgesiaMedical EducationObstetric Anesthesia

Investigational drug(s) / intervention(s)

Epidural Simulation TrainingStandard Clinical Training

Epidural Simulation Training: The group will have access to a epidural simulator and would have possibility to freely experiment and improve their skill on the phantom before their residency period in the obstetric unit

Standard Clinical Training: Participants will receive a standard clinical training based on frontal lessons regarding indications , controindications to epidural analgesia and the technique will be explained also with the use of video material

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Residents in Anesthesia * Informed Consent Exclusion Criteria: * An experience of 20 or more epidural catheter positioning * Experience with epidural simulator

Primary outcome measure(s)

  • Success Rate of Epidural Catheter Placement — 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.

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Padua Padova Italy Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07056140 on ClinicalTrials.gov ↗ ← All trials in Italy