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

Last updated: February 6, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

Ultrasound guided injection with local anaestethic

Clinical Study ID

NCT06811649
OST-22-01
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant patients >18 years of age with no BMI (Body Mass Index) limitation

  • Pregnant patients requiring partoanalgesia

  • Obtaining informed consent for study participation

Exclusion

Exclusion Criteria:

  • Patients with contraindications to epidural catheter placement

  • Endocranial hypertension

  • Coagulopathies

  • Severe thrombocytopenia < 75,000 per mm^3.

Study Design

Total Participants: 146
Treatment Group(s): 1
Primary Treatment: Ultrasound guided injection with local anaestethic
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

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