MedTrace Logo

Simulation-Based Training for Epidural Analgesia Placement

NCT07056140 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-09-15

No results posted yet for this 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.

Conditions

  • Epidural Analgesia
  • Medical Education
  • Obstetric Anesthesia

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Alessandro De Cassai · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-12
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07056140 on ClinicalTrials.gov