Simulation-Based Training for Epidural Analgesia Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Padova
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Residents in Anesthesia
Informed Consent
Disqualifiers
An experience of 20 or more epidural catheter positioning
Experience with epidural simulator
Trial design
Design model
Parallel
Treatments tested in this trial
Epidural Simulation Training
Procedure/SurgeryThe 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/SurgeryParticipants 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
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Epidural Simulator Training GroupExperimental treatment 2 interventions
Group B: Traditional Training GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Success Rate of Epidural Catheter Placement
Defined as successful placement of the epidural catheter in the correct anatomical space as determined by supervising anesthesiologist.
Time frame
Immediately following the procedure, up to 45 minutes after the enorllment.Secondary outcomes
1
Number of Attempts Required for Successful Placement of the Epidural Cathter
Total number of needle insertions until successful catheter placement is achieved.
Time frame
During the procedure, from the enrollment up to 45 minutes after the enorllment2
Incidence of Accidental Dural Puncture (Complication)
Number of procedures resulting in unintentional puncture of the dura mater.
Time frame
During the procedure from the enrollment up to 45 minutes after the enorllment3
Incidence of Bloody Tap (Complication)
Occurrence of blood in the epidural needle or catheter upon insertion.
Time frame
During the procedure, from the enrollment up to 45 minutes after the enorllment4
Incidence of Supervisor intervention
The procedure required the attending anesthesiologist intervention to be completed
Time frame
During the procedure, from the enrollment up to 45 minutes after the enorllmentSponsors and contacts
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Source ClinicalTrials.gov