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Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient

Study acronym: OST-22-01
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 10, 2025 (before its estimated March 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Secondary endpoint revisedv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident. Specifically, to demonstrate how the aid of echo-assistance in the evaluation of the spine increases the atraumatic success rate (primary objective) and reduces the number of complications (particularly, the number of attempts needed and the rate of dura puncture) (secondary objective) in physicians in specialty training. Pregnant patients requiring peridural analgesia will be assigned to the intervention or control group by simple randomization.
Trial Details
NCT Number NCT06811649
Lead Sponsor IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions
(from sponsor)
Pregnancy
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov