Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06811649

Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for Epidural Catheter Placement in Pregnant Patients by Anesthesia Residents

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-10

146

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether using ultrasound guidance during epidural catheter placement can improve the skill and success rate of anesthesia residents working with pregnant patients. This trial aims to show if ultrasound assistance increases the chance of atraumatic puncture and reduces complications such as multiple attempts or accidental puncture of the dura. The study focuses on pregnant women needing peridural analgesia during childbirth and involves residents in anesthesiology training. Participants will be randomly assigned to one of two groups: one group will receive the echo-assisted technique, which combines ultrasound assessment with traditional palpation to find the best spot for epidural catheter insertion. The other group will undergo the traditional technique relying solely on anatomical landmarks felt by touch. The ultrasound-assisted method involves a pre-procedure to enhance accuracy. This open-label trial is conducted at a single center and aims to compare these two approaches. During the study, researchers will monitor the rate of successful atraumatic punctures and track any complications such as the number of attempts and dura puncture rates over about one year. Pregnant participants will provide informed consent and be assessed during epidural placement. The trial includes safety monitoring and outcome measurement focused on improving the training and performance of resident anesthesiologists.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant patients over 18 years old with no BMI limitation
  • Pregnant patients requiring partoanalgesia
  • Must provide informed consent for study participation
Not Eligible

You will not qualify if you...

  • Patients with contraindications to epidural catheter placement
  • Patients with intracranial hypertension
  • Patients with coagulopathies
  • Patients with severe thrombocytopenia (platelet count below 75,000 per mm3)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure during labor

Participants receive either the echo-assisted ALR technique or the traditional ALR technique for epidural catheter placement during labor.

1 procedure visit (in-person)

Follow-up

Duration - Up to 1 year through study completion

Participants are followed for safety and monitoring for complications related to the epidural catheter placement.

Periodic follow-up visits as scheduled by the study team

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

A

Aurora Guglielmetti, MD

A

Aurora Guglielmetti, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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