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NCT Number: NCT07426679

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

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.

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Key information

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive care, Kolding, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-assisted spinal anaesthesia

Procedure

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

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 outcomes

  1. Successful first spinal block attempt

    Time frame: During spinal blocks

    Single skin puncture without redirection and with backflow of cerebrospinal fluid

Secondary outcomes

  1. Number of attempts

    Time frame: During block

    Number of skin punctures

  2. Number of redirections

    Time frame: During block

    Number of needle redirections

  3. Successful block for operation

    Time frame: During block

    Yes/no

  4. Need for supervisor's verbal help

    Time frame: during block

    Verbal guidance

  5. Need for supervisor's technical assistance

    Time frame: During block

    Manual procedural assistance

  6. Time spent

    Time frame: During block

    Duration to backflow of cerebrospinal fluid from the time of needle insertion

  7. Need for sedation during spinal anaesthesia placement

    Time frame: During block

    Yes/no

  8. Additional intervention required intraoperatively- unexpected general anaesthesia

    Time frame: During block

    Unexpected general anaesthesia-and if so, the reason

  9. Additional intervention required intraoperatively- need for sedation

    Time frame: During block

    • and if so, the reason
  10. Expected difficult access

    Time frame: During block

    Yes-if yes, why:

Other outcomes

  1. Patient Satisfaction

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

    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)

  2. Complications from procedure day to day 7

    Time frame: From day 0 to day 7

    Post-- dural puncture headache, local infection or paraesthesia

Study contacts

Contact information is provided by the study sponsor or research team.

Martine Siw Nielsen,, M.D

CONTACT

[email protected]

+4520811044

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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