Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound-assisted spinal anaesthesia, Control group.
- Who it may be relevant to
- Registry conditions: Ultrasound, Spinal Anaesthesia, Simulation Based Medical Education. Basic parameters: 18 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study
Overview
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
- Procedure Ultrasound-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. - Procedure Control 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.
Primary outcome measures
- Successful first spinal block attempt [Time frame: During spinal blocks]
Secondary outcome measures (10)
- Number of attempts [Time frame: During block]
- Number of redirections [Time frame: During block]
- Successful block for operation [Time frame: During block]
- Need for supervisor's verbal help [Time frame: during block]
- Need for supervisor's technical assistance [Time frame: During block]
- Time spent [Time frame: During block]
- Need for sedation during spinal anaesthesia placement [Time frame: During block]
- Additional intervention required intraoperatively- unexpected general anaesthesia [Time frame: During block]
- Additional intervention required intraoperatively- need for sedation [Time frame: During block]
- Expected difficult access [Time frame: During block]
Eligibility criteria
Inclusion criteria
- Physicians will be included using the following inclusion criteria:
- Physicians working in anaesthesia
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 2 centers
- Department of Anaesthesiology and Intensive care — Kolding
- Martine Siw Nielsen — Kolding
Identifiers
NCT: NCT07426679 · 25/50538