RecruitingNot ApplicableNCT06811649

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

146 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

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Interventions

DIAGNOSTIC_TESTUltrasound guided injection with local anaestethic

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.


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT06811649


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