About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Physicians working in anaesthesia
Opportunity to use the spinal block technique within 2 weeks of the training session.
Disqualifiers
Exclusion criteria: Patients under 18 years of age.
Trial design
Parallel
Treatments tested in this trial
Ultrasound-assisted spinal anaesthesia
Procedure/SurgeryParticipants 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
Procedure/SurgeryParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Successful first spinal block attempt
Single skin puncture without redirection and with backflow of cerebrospinal fluid
Secondary outcomes
Number of attempts
Number of skin punctures
Number of redirections
Number of needle redirections
Successful block for operation
Yes/no
Need for supervisor's verbal help
Verbal guidance
Other outcomes
Patient Satisfaction
Periprocedural pain score (0, no pain; 10, worst pain imaginable) Periprocedural discomfort (0, no discomfort; 10, worst discomfort imaginable) Satisfaction in general (very satisfied, satisfied, or dissatisfied)
Complications from procedure day to day 7
Post-- dural puncture headache, local infection or paraesthesia
Sponsors and contacts
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