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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
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.
Department of Anaesthesiology and Intensive care
Kolding, Denmark
RECRUITINGMartine Siw Nielsen
Kolding, Denmark
NOT_YET_RECRUITINGSuccessful first spinal block attempt
Single skin puncture without redirection and with backflow of cerebrospinal fluid
Time frame: During spinal blocks
Number of attempts
Number of skin punctures
Time frame: During block
Number of redirections
Number of needle redirections
Time frame: During block
Successful block for operation
Yes/no
Time frame: During block
Need for supervisor's verbal help
Verbal guidance
Time frame: during block
Need for supervisor's technical assistance
Manual procedural assistance
Time frame: During block
Time spent
Duration to backflow of cerebrospinal fluid from the time of needle insertion
Time frame: During block
Need for sedation during spinal anaesthesia placement
Yes/no
Time frame: During block
Additional intervention required intraoperatively- unexpected general anaesthesia
Unexpected general anaesthesia-and if so, the reason
Time frame: During block
Additional intervention required intraoperatively- need for sedation
\- and if so, the reason
Time frame: During block
Expected difficult access
Yes-if yes, why:
Time frame: During block
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