Actively Recruiting
Effectiveness of Simulation-Based Training for Epidural Analgesia Placement in Obstetric Settings: A Prospective, Randomized, Monocentric Study
Led by University of Padova · Updated on 2025-09-15
86
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether simulation-based training can improve the success rate of epidural catheter placement for anesthesia residents in obstetric anesthesia. Epidural analgesia is widely recommended for managing labor pain but can be technically challenging, especially for trainees. This prospective, randomized, single-center study compares simulator training combined with an anatomy lecture against standard clinical training without simulation for anesthesia residents in their 4th or 5th year with limited prior epidural experience. Participants will be randomly assigned to one of two groups: an intervention group receiving a frontal anatomy lecture and a 3-hour practical session using high-fidelity epidural simulators before their labor ward rotation, and a control group receiving standard theoretical clinical training without simulator practice. All epidural catheter placements during labor ward rotations will be supervised, with detailed data collection on success rates, procedure time, complications, and resident satisfaction. During the study, each epidural procedure attempt will be closely monitored, with structured case report forms completed immediately after the procedure up to 45 minutes post-enrollment. Researchers will measure the number of successful catheter placements without tutor help as the primary outcome. Secondary outcomes include procedure attempts, complications like accidental dural puncture or bloody tap, and success rates during day versus night shifts. Data will be securely stored and analyzed under ethical guidelines, with participation lasting through the residents' labor ward rotation period.
CONDITIONS
Brief Title
Simulation-Based Training for Epidural Analgesia Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Residents in Anesthesia
- Informed Consent
You will not qualify if you...
- Experience of 20 or more epidural catheter placements
- Previous experience with epidural simulator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short term before residency period
Participants receive either epidural simulation training with a 3-hour practical session and anatomy lecture or standard clinical training with theoretical lessons and video material before starting their residency period.
1 training session (in-person)
Duration - Up to 45 minutes per procedure after enrollment
Participants perform epidural catheter placements on patients during their labor ward rotation under supervision, with outcomes recorded during each procedure.
Multiple supervised procedures during residency period
Trial Site Locations
Total: 1 location
1
University Hospital of Padua
Padova, Italy, 35127
Actively Recruiting
Research Team
S
Sabina Medical Doctor, Rizzi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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