Actively Recruiting
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
Eligibility Criteria
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
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
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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