Simulation-Based Training for Epidural Analgesia Placement

Effectiveness of Simulation-Based Training for Epidural Analgesia Placement in Obstetric Settings: A Prospective, Randomized, Monocentric Study

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.

Study Overview

• Status: Recruiting
• Conditions: Epidural Analgesia; Medical Education; Obstetric Anesthesia
• Intervention / Treatment: Procedure: Epidural Simulation Training; Procedure: Standard Clinical Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabina Medical Doctor, Rizzi; Phone Number: +390498213090; Email: sabina.rizzi@aopd.veneto.it

Study Locations

• Italy
  • Padua, Italy, 35127
    • Recruiting
    • University Hospital of Padua
    • Contact: Sabina Rizzi, Medical Doctor; Phone Number: +390498213090; Email: sabina.rizzi@aopd.veneto.it
    • Sub-Investigator: Fabrizia Calabrese, Medical Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Residents in Anesthesia
• Informed Consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural Simulator Training Group; Participants receive training using the epidural simulator before starting their residency period and actually performing procedures on patients.	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
Active Comparator: Traditional Training Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Attempts Required for Successful Placement of the Epidural Cathter	Total number of needle insertions until successful catheter placement is achieved.	During the procedure, from the enrollment up to 45 minutes after the enorllment
Incidence of Accidental Dural Puncture (Complication)	Number of procedures resulting in unintentional puncture of the dura mater.	During the procedure from the enrollment up to 45 minutes after the enorllment
Incidence of Bloody Tap (Complication)	Occurrence of blood in the epidural needle or catheter upon insertion.	During the procedure, from the enrollment up to 45 minutes after the enorllment
Incidence of Supervisor intervention	The procedure required the attending anesthesiologist intervention to be completed	During the procedure, from the enrollment up to 45 minutes after the enorllment
Success Rate of Epidural Catheter Positioning During the Day Shift	Defined as successful placement of epidural catheters positioned from 08:00 AM to 08:00 PM in the correct anatomical space as determined by supervising anesthesiologist	During the procedure, from the enrollment up to 45 minutes after the enorllment
Success Rate of Epidural Catheter Positioning During the Night Shift	Defined as successful placement of epidural catheters positioned from 08:00 PM to 08:00 AM in the correct anatomical space as determined by supervising anesthesiologist	During the procedure, from the enrollment up to 45 minutes after the enorllment
Time to Complete the Epidural Catheter Positioning	Time to complete the epidural catheter positioning from the skin disinfection to the needle removal	From the start to the end of the procedure, from the enrollment up to 45 minutes after the enrollment

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Alessandro De Cassai, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: June 28, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Epidural analgesia; Medical education; Obstetric anesthesia; Simulation training; Epidural catheter placement; Obstetric simulation; Anesthesia training; Technical skills
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 546n/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No