Simulation Based Medical Education, Spinal Anaesthesia, Ultrasound
Conditions
Brief 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.
Interventions
PROCEDUREUltrasound-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.
PROCEDUREControl 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.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful first spinal block attempt | During spinal blocks | Single skin puncture without redirection and with backflow of cerebrospinal fluid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts | During block | Number of skin punctures |
| Number of redirections | During block | Number of needle redirections |
| Successful block for operation | During block | Yes/no |
| Need for supervisor's verbal help | during block | Verbal guidance |
| Need for supervisor's technical assistance | During block | Manual procedural assistance |
| Time spent | During block | Duration to backflow of cerebrospinal fluid from the time of needle insertion |
| Need for sedation during spinal anaesthesia placement | During block | Yes/no |
| Additional intervention required intraoperatively- unexpected general anaesthesia | During block | Unexpected general anaesthesia-and if so, the reason |
| Additional intervention required intraoperatively- need for sedation | During block | \- and if so, the reason |
| Expected difficult access | During block | Yes-if yes, why: |
Countries
Denmark
Contacts
CONTACTMartine Siw Nielsen,, M.D
Outcome results
None listed