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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-18
SponsorUniversity of Southern Denmark

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-assisted spinal anaesthesia

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Ultrasound-assisted spinal anaesthesiaExperimental treatment 1 intervention
Group B: Manual palpation technique for spinal anaesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Successful first spinal block attempt

Single skin puncture without redirection and with backflow of cerebrospinal fluid

Time frame
During spinal blocks

Secondary outcomes

1

Number of attempts

Number of skin punctures

Time frame
During block
2

Number of redirections

Number of needle redirections

Time frame
During block
3

Successful block for operation

Yes/no

Time frame
During block
4

Need for supervisor's verbal help

Verbal guidance

Time frame
during block

Other outcomes

1

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)

Time frame
Following the placement the block - follow up within 7 days
2

Complications from procedure day to day 7

Post-- dural puncture headache, local infection or paraesthesia

Time frame
From day 0 to day 7

Sponsors and contacts

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