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NCT Number: NCT06811649

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • Patients with contraindications to epidural catheter placement
  • Endocranial hypertension
  • Coagulopathies
  • Severe thrombocytopenia < 75,000 per mm^3.

Treatment and study plan

Ultrasound guided injection with local anaestethic

Diagnostic Test

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.

Primary outcomes

  1. the rate of FNP (thus atraumatic puncture)

    Time frame: Through study completion,an average of 1 year

    The primary objective of this study is to demonstrate whether or not the aid of echo-assistance in spinal evaluation, performed by an experienced anesthesiologist, increases the atraumatic success rate, First Needle Pass (FNP), in epidural catheter placement by inexperienced personnel (physicians in specialty training, MFS).

    This objective will be calculated by observing the rate of FNP (thus atraumatic puncture).

Secondary outcomes

  1. Change the number of complications

    Time frame: Through study completion,an average of 1 year

    The secondary objective is to demonstrate whether the aid of echo-assistance in the evaluation of the spine, performed by an experienced anesthesiologist, reduces the number of complications (particularly the number of attempts needed and the rate of dura puncture, (accidental dural puncture, ADP) in epidural catheter placement by inexperienced personnel (physicians in specialty training).

    The following outcomes will be considered to assess this objective:

    • number of traumatic punctures defined as: presence of redirects or number of punctures greater than one
    • median number of multiple punctures
    • number of women with failure (defined as number of punctures > 3)
    • number of accidental dural punctures (detected as CSF leaks).

Study contacts

Contact information is provided by the study sponsor or research team.

Aurora Guglielmetti, MD

CONTACT

[email protected]

0039 05121414378

Aurora Guglielmetti, MD

CONTACT

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: OST-22-01

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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