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

NCT07426679 | Recruiting

• 1 other identifier: 25/50538
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ultrasound; Spinal Anaesthesia; Simulation Based Medical Education

Outcome Measures

Primary Outcomes (1)

• Successful first spinal block attempt

  Single skin puncture without redirection and with backflow of cerebrospinal fluid

  During spinal blocks

Secondary Outcomes (10)

• Number of attempts

  During block

• Number of redirections

  During block

• Successful block for operation

  During block

• Need for supervisor's verbal help

  during block

• Need for supervisor's technical assistance

  During block

Other Outcomes (2)

• Patient Satisfaction

  Following the placement the block - follow up within 7 days

• Complications from procedure day to day 7

  From day 0 to day 7

Study Arms (2)

Ultrasound-assisted spinal anaesthesia

EXPERIMENTAL

Participants will be trained using ultrasound to assist spinal anaesthesia

Procedure: Ultrasound-assisted spinal anaesthesia

Manual palpation technique for spinal anaesthesia

ACTIVE COMPARATOR

Participants will be trained using standard methods of manual palpation technique for spinal anaesthesia

Procedure: Control group

Interventions

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.

Ultrasound-assisted spinal anaesthesia

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.

Manual palpation technique for spinal anaesthesia

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (2)

Department of Anaesthesiology and Intensive care

Kolding, Denmark

RECRUITING

Martine Siw Nielsen

Kolding, Denmark

NOT YET RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Martine Siw Nielsen,, M.D

CONTACT

+4520811044; Martine.Siw.Nielsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

DK (2)