Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient (OST-22-01)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Pregnancy

Treatments: Diagnostic Test: Ultrasound guided injection with local anaestethic

Study type: Interventional

Funder types: Other

Identifiers

NCT06811649

OST-22-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

echo-assisted ALR (loco-regional anesthesia) technique

Experimental group

Description:

Ultrasound evaluation of the spine as an aid in facilitating the placement of an epidural catheter

Treatment:

Diagnostic Test: Ultrasound guided injection with local anaestethic

traditional ALR technique

No Intervention group

Description:

The traditional neuroaxial technique involves palpation of the spinous processes and iliac crests to recognize the median and height of the lumbar interspace to be used to perform a neuroaxial block