Simulation-Based Training for Epidural Analgesia Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epidural Simulation Training, Standard Clinical Training.
- Who it may be relevant to
- Registry conditions: Epidural Analgesia, Medical Education, Obstetric Anesthesia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Simulation-Based Training for Epidural Analgesia Placement in Obstetric Settings: A Prospective, Randomized, Monocentric Study
Overview
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.
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
Primary outcome measures
- Success Rate of Epidural Catheter Placement [Time frame: Immediately following the procedure, up to 45 minutes after the enorllment.]
Secondary outcome measures (7)
- 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]
- Incidence of Accidental Dural Puncture (Complication) [Time frame: During the procedure from the enrollment up to 45 minutes after the enorllment]
- Incidence of Bloody Tap (Complication) [Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment]
- Incidence of Supervisor intervention [Time frame: During the procedure, from the enrollment up to 45 minutes after the enorllment]
- 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]
- 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]
- 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]
Eligibility criteria
Inclusion criteria
- Residents in Anesthesia
- Informed Consent
Exclusion criteria
- An experience of 20 or more epidural catheter positioning
- Experience with epidural simulator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- University Hospital of Padua — Padova
Identifiers
NCT: NCT07056140 · 546n/25