Simulation-Based Training for Epidural Analgesia Placement

NCT07056140 | Recruiting

• 1 other identifier: 546n/25
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Epidural analgesia; Obstetric anesthesia; Epidural catheter placement; Simulation training; Medical education; Obstetric simulation; Anesthesia training; Technical skills

Outcome Measures

Primary Outcomes (1)

• Success Rate of Epidural Catheter Placement

  Defined as successful placement of the epidural catheter in the correct anatomical space as determined by supervising anesthesiologist.

  Immediately following the procedure, up to 45 minutes after the enorllment.

Secondary Outcomes (7)

• 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

Study Arms (2)

Epidural Simulator Training Group

EXPERIMENTAL

Participants receive training using the epidural simulator before starting their residency period and actually performing procedures on patients.

Procedure: Epidural Simulation Training; Procedure: Standard Clinical Training

Traditional Training Group

ACTIVE COMPARATOR

Participants receive standard theorical clinical training without the use of the epidural simulator before their residency period in the obstetric unit

Procedure: Standard Clinical Training

Interventions

Epidural Simulation Training PROCEDURE

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

Epidural Simulator Training Group

Standard Clinical Training PROCEDURE

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

Epidural Simulator Training Group; Traditional Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents in Anesthesia
• Informed Consent

You may not qualify if:

• An experience of 20 or more epidural catheter positioning
• Experience with epidural simulator

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padua

Padua, 35127, Italy

RECRUITING

Study Officials

• Alessandro De Cassai

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabina Medical Doctor, Rizzi

CONTACT

+390498213090; sabina.rizzi@aopd.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups: a standard training group or an enhanced simulation-based training group for epidural placement. Each participant will receive only one type of intervention, with no crossover between groups.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 9, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

IT (1)