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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- the rate of FNP (thus atraumatic puncture)
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
echo-assisted ALR (loco-regional anesthesia) technique
Ultrasound evaluation of the spine as an aid in facilitating the placement of an epidural catheter
Intervention: Ultrasound guided injection with local anaestethic (Diagnostic Test)
traditional ALR technique
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
Outcomes
Primary Outcomes
the rate of FNP (thus atraumatic puncture)
Time Frame: Through study completion,an average of 1 year
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).
Secondary Outcomes
- Change the number of complications(Through study completion,an average of 1 year)