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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Spinal Anaesthesia; Simulation Based Medical Education
• Intervention / Treatment: Procedure: Ultrasound-assisted spinal anaesthesia; Procedure: Control group

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martine Siw Nielsen,, M.D; Phone Number: +4520811044; Email: Martine.Siw.Nielsen@rsyd.dk

Study Locations

• Denmark
  • Kolding, Denmark
    • Recruiting
    • Department of Anaesthesiology and Intensive care
    • Contact: Martine S Nielsen, MD; Phone Number: +4520811044; Email: Martine.siw.nielsen@rsyd.dk
  • Kolding, Denmark
    • Not yet recruiting
    • Martine Siw Nielsen
    • Contact: Martine Siw Nielsen, MD; Phone Number: +4520811044; Email: Martine.Siw.Nielsen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Physicians will be included using the following inclusion criteria:

  1. Physicians working in anaesthesia
  2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-assisted spinal anaesthesia; Participants will be trained using ultrasound to assist spinal anaesthesia	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.
Active Comparator: Manual palpation technique for spinal anaesthesia; Participants will be trained using standard methods of manual palpation technique for spinal anaesthesia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful first spinal block attempt	Single skin puncture without redirection and with backflow of cerebrospinal fluid	During spinal blocks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts	Number of skin punctures	During block
Number of redirections	Number of needle redirections	During block
Successful block for operation	Yes/no	During block
Need for supervisor's verbal help	Verbal guidance	during block
Need for supervisor's technical assistance	Manual procedural assistance	During block
Time spent	Duration to backflow of cerebrospinal fluid from the time of needle insertion	During block
Need for sedation during spinal anaesthesia placement	Yes/no	During block
Additional intervention required intraoperatively- unexpected general anaesthesia	Unexpected general anaesthesia-and if so, the reason	During block
Additional intervention required intraoperatively- need for sedation	- and if so, the reason	During block
Expected difficult access	Yes-if yes, why:	During block

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Following the placement the block - follow up within 7 days
Complications from procedure day to day 7	Post-- dural puncture headache, local infection or paraesthesia	From day 0 to day 7

Collaborators and Investigators

• Sponsor: University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 25/50538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No