Epidural AnalgesiaNCT07056140
Simulation-Based Training for Epidural Analgesia Placement
A study testing Epidural Simulation Training and Standard Clinical Training in people with Epidural Analgesia and Medical Education, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidural Analgesia, Medical Education, Obstetric Anesthesia
- What is being tested?
- Epidural Simulation Training and Standard Clinical Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents in Anesthesia
- Informed Consent
Who cannot join
- An experience of 20 or more epidural catheter positioning
- Experience with epidural simulator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Padua
Padova, 35127
Sabina Rizzi, Medical Doctor, +390498213090, sabina.rizzi@aopd.veneto.it
Fabrizia Calabrese, Medical Doctor
About this study
Official title: 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.
Read the 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
- Being tested
- Epidural Simulation Training, Standard Clinical Training
- Keywords
- Epidural analgesia, Obstetric anesthesia, Epidural catheter placement, Simulation training, Medical education, Obstetric simulation, Anesthesia training, Technical skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Simulation TrainingProcedure or surgery
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 TrainingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Epidural Simulator Training Group | Experimental | Participants receive training using the epidural simulator before starting their residency period and actually performing procedures on patients. Receives: 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 Receives: Procedure: Standard Clinical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Epidural Catheter Placement
Defined as successful placement of the epidural catheter in the correct anatomical space as determined by supervising anesthesiologist.
Measured: 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
Total number of needle insertions until successful catheter placement is achieved.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the start to the end of the procedure, from the enrollment up to 45 minutes after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start12 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
- Investigators
- Alessandro De Cassai, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056140
- Sponsor's protocol ID
- 546n/25
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Simulation-Based Training for Epidural Analgesia Placement in Obstetric Settings: A Prospective, Randomized, Monocentric Study
- ClinicalTrials.gov ID
- NCT07056140
- Acronym / sponsor ID
- 546n/25
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Epidural Simulator Training Group | Experimental | Procedure: Epidural Simulation Training, Procedure: Standard Clinical TrainingParticipants receive training using the epidural simulator before starting their residency period and actually performing procedures on patients. |
| Traditional Training Group | Active comparator | Procedure: Standard Clinical TrainingParticipants receive standard theorical clinical training without the use of the epidural simulator before their residency period in the obstetric unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residents in Anesthesia
- Informed Consent
Key exclusion criteria (2 listed)
- An experience of 20 or more epidural catheter positioning
- Experience with epidural simulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Simulation TrainingThe 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 or surgery | Epidural Simulator Training Group |
| Standard Clinical TrainingParticipants 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 | Procedure or surgery | Epidural Simulator Training Group, Traditional Training Group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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EpiFaith Resident Learning Curve Trial
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Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro De Cassai principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Simulation Training and Standard Clinical Training in people with Epidural Analgesia and Medical Education, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabina Medical Doctor, Rizzi (+390498213090, sabina.rizzi@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Epidural Catheter Placement (time frame: Immediately following the procedure, up to 45 minutes after the enorllment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.