Simulation-Based Training for Epidural Analgesia Placement

NCT ID: NCT07056140

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-12
• Study Completion Date: 2027-07-31

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.

Detailed Description

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.

Conditions

Epidural Analgesia; Medical Education; Obstetric Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Epidural Simulator Training Group

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

Group Type: EXPERIMENTAL

Epidural Simulation Training

Intervention Type: 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

Standard Clinical Training

Intervention Type: 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

Traditional Training Group

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

Group Type: ACTIVE_COMPARATOR

Standard Clinical Training

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Residents in Anesthesia
• Informed Consent

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Alessandro De Cassai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro De Cassai

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

University Hospital of Padua

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sabina Medical Doctor, Rizzi

Role: CONTACT

sabina.rizzi@aopd.veneto.it

+390498213090

Facility Contacts

Sabina Rizzi, Medical Doctor

Role: primary

sabina.rizzi@aopd.veneto.it

+390498213090

Other Identifiers

546n/25

Identifier Type: -

Identifier Source: org_study_id