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

NCT06811649 | Recruiting

• 1 other identifier: OST-22-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

epidural catheter; loco-regional anesthesia

Outcome Measures

Primary Outcomes (1)

• the rate of FNP (thus atraumatic puncture)

  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).

  Through study completion,an average of 1 year

Secondary Outcomes (1)

• Change the number of complications

  Through study completion,an average of 1 year

Study Arms (2)

echo-assisted ALR (loco-regional anesthesia) technique

EXPERIMENTAL

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

Diagnostic Test: Ultrasound guided injection with local anaestethic

traditional ALR technique

NO INTERVENTION

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

Interventions

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.

echo-assisted ALR (loco-regional anesthesia) technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients \>18 years of age with no BMI (Body Mass Index) limitation
• Pregnant patients requiring partoanalgesia
• Obtaining informed consent for study participation

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Aurora Guglielmetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurora Guglielmetti, MD

CONTACT

0039 05121414378; aurora.guglielmetti@aosp.bo.it

Aurora Guglielmetti, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: July 17, 2023
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

IT (1)