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NCT Number: NCT07056140

Simulation-Based Training for Epidural Analgesia Placement

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.

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Key information

Conditions

Epidural Analgesia Medical Education Obstetric Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Padua

Padova, 35127, Italy

Location status: Recruiting

Location contact

Fabrizia Calabrese, Medical Doctor

SUB_INVESTIGATOR

Sabina Rizzi, Medical Doctor

CONTACT

[email protected]

+390498213090

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residents in Anesthesia
  • Informed Consent

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. Success Rate of Epidural Catheter Placement

    Time frame: 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.

Secondary outcomes

  1. Number of Attempts Required for Successful Placement of the Epidural Cathter

    Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment

    Total number of needle insertions until successful catheter placement is achieved.

  2. Incidence of Accidental Dural Puncture (Complication)

    Time frame: During the procedure from the enrollment up to 45 minutes after the enorllment

    Number of procedures resulting in unintentional puncture of the dura mater.

  3. Incidence of Bloody Tap (Complication)

    Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment

    Occurrence of blood in the epidural needle or catheter upon insertion.

  4. Incidence of Supervisor intervention

    Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment

    The procedure required the attending anesthesiologist intervention to be completed

  5. Success Rate of Epidural Catheter Positioning During the Day Shift

    Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment

    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

  6. Success Rate of Epidural Catheter Positioning During the Night Shift

    Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment

    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

  7. Time to Complete the Epidural Catheter Positioning

    Time frame: From the start to the end of the procedure, from the enrollment up to 45 minutes after the enrollment

    Time to complete the epidural catheter positioning from the skin disinfection to the needle removal

Study contacts

Contact information is provided by the study sponsor or research team.

Sabina Medical Doctor, Rizzi

CONTACT

[email protected]

+390498213090

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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