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Recruiting Not applicable

Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?

NCT07426679 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-02-01
Last updated
2026-02-23

Condition(s) studied

UltrasoundSpinal AnaesthesiaSimulation Based Medical Education

Investigational drug(s) / intervention(s)

Ultrasound-assisted spinal anaesthesiaControl group

Ultrasound-assisted spinal anaesthesia: Participants will received simulation-based training in ultrasound-assisted spinal anaesthesia based on a mastery-based learning structure. Following this, they will perform two ultrasound-assisted spinal blocks on patients.

Control group: Participants will receive simulation based training in traditional palpation technique for spinal anaesthesia based on a mastery learning concept. Follow this, they will perform two spinal blocks on participants using this method.

Study summary

Neuraxial blockade is commonly performed using a manual palpation technique, but the procedure can be challenging, particularly in patients with high body mass index, pregnancy, or spinal deformities. Preprocedural ultrasound may improve identification of the optimal injection site, yet its use in clinical practice remains limited, partly due to a lack of structured training.

This multicentre randomised controlled trial investigates whether anaesthesiologists performing ultrasound-assisted spinal anaesthesia achieve better clinical outcomes and higher patient satisfaction compared with the traditional manual palpation technique. Both novice anaesthesia residents and more experienced anaesthesiologists are included.

Participants receive structured simulation-based training using either ultrasound-assisted or manual palpation techniques, following a mastery learning approach with predefined performance standards. After certification, participants perform spinal anaesthesia during elective lower limb surgery, with clinical performance assessed by senior anaesthesiologists.

The primary outcome is first-attempt success of spinal block. Secondary outcomes include number of attempts, needle redirections, time spent, need for assistance, and overall block success. Patient satisfaction and complications are assessed as tertiary outcomes.

This study aims to provide evidence on the clinical effects of structured training in ultrasound-assisted neuraxial access and to explore the role of prior clinical experience.

Eligibility

Sex
ALL
Min age
18 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Physicians will be included using the following inclusion criteria: 1. Physicians working in anaesthesia 2. Opportunity to use the spinal block technique within 2 weeks of the training session. Eligible patients will be those scheduled for elective lower limb surgery requiring spinal anaesthesia. Exclusion Criteria: * Exclusion criteria: Patients under 18 years of age.

Primary outcome measure(s)

  • Successful first spinal block attempt — During spinal blocks
    Single skin puncture without redirection and with backflow of cerebrospinal fluid

Trial sites (2)

FacilityCityRegionStatus
Department of Anaesthesiology and Intensive care Kolding Denmark Recruiting
Martine Siw Nielsen Kolding Denmark Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07426679 on ClinicalTrials.gov ↗ ← All trials in Denmark