Teaching anesthesiologists ultrasound-assisted neuraxial access for spinal anesthesia
Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study
This trial will test whether training anesthesiologists to use ultrasound for spinal anesthesia improves clinical outcomes and patient satisfaction for adults having elective lower limb surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 2 sites (Kolding and 1 other locations) |
| Trial ID | NCT07426679 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial randomizes anesthesia physicians to receive structured, mastery-based simulation training in either ultrasound-assisted or traditional manual palpation spinal anesthesia techniques. After meeting predefined performance standards and receiving certification, physicians perform spinal anesthesia for adults undergoing elective lower limb surgery and outcomes from their clinical cases are collected. Primary outcomes include procedural performance measures such as first-attempt success, number of needle passes, complication rates, and patient satisfaction. The trial includes both novice anesthesia residents and more experienced anesthesiologists at participating centers.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective lower limb surgery who will receive spinal anesthesia at a participating center.
Not a fit: Patients under 18, those undergoing emergency surgery, those not receiving spinal anesthesia, or those with contraindications to neuraxial blockade are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, patients could have higher first-attempt success rates, fewer needle passes and complications, and greater satisfaction with their spinal anesthesia experience.
How similar studies have performed: Smaller trials and simulation-based training programs have shown that preprocedural ultrasound and mastery learning can improve neuraxial procedural success and trainee skill, but large randomized multicenter data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kolding and 1 other locations
- Department of Anaesthesiology and Intensive care — Kolding, Denmark (Recruiting)
- Martine Siw Nielsen — Kolding, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Martine Siw Nielsen,, M.D
- Email: Martine.Siw.Nielsen@rsyd.dk
- Phone: +4520811044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.