NCT06811649

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

Comparison of Echo-assisted ALR (Loco-regional Anesthesia) Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Performed by an Anesthesia Resident

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The use of echo-assisted assessment has been studied for about a decade, showing encouraging results as far as experienced medical personnel are concerned, but to date, a systematic study assessing the usefulness of this aid in improving residents' competence (as indicated by the 2019 systematic review) is lacking in the literature. To date, echo-assisted assessment is not routinely applied to all obstetric patients, as it is a relatively new technique and not yet widely used by all anesthesiologists. If the results of the study are positive,echo-assisted assessment use could be expanded, reducing the number of complications and increasing the number of atraumatic epidural catheter placements.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound guided injection with local anaestethic	Experimental treatment consists of ultrasound assessment combined with palpatory assessment to identify the most suitable space for epidural catheter insertion. The conventional neuroaxial technique relies on palpation of the spinous processes and iliac crests to recognize the midline and height of the lumbar interspace to be used to perform a neuroaxial block. With the echo-assisted technique, in aid of the conventional technique, a preprocedure (Prepuncture) is performed for the purpose of combining classic anatomical findings with useful sonographic findings that should improve the success of the neuroaxial technique.

Timeline

• Start date: 2023-07-17
• Primary completion: 2025-03-31
• Completion: 2025-07-31
• First posted: 2025-02-06
• Last updated: 2025-02-10

Locations

1 site across 1 country: Italy