UltrasoundNCT07426679
Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?
A study testing Ultrasound-assisted spinal anaesthesia in people with Ultrasound and Spinal Anaesthesia, run by University of Southern Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Ultrasound, Spinal Anaesthesia, Simulation Based Medical Education
- What is being tested?
- Ultrasound-assisted spinal anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Anaesthesiology and Intensive care
Kolding
Martine S Nielsen, MD, +4520811044, Martine.siw.nielsen@rsyd.dk
- Not yet recruiting
Martine Siw Nielsen
Kolding
Martine Siw Nielsen, MD, +4520811044, Martine.Siw.Nielsen@rsyd.dk
About this study
Official title: 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.
Read more
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.
- Being tested
- Ultrasound-assisted spinal anaesthesia, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-assisted spinal anaesthesiaProcedure or 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 groupProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-assisted spinal anaesthesia | Experimental | Participants will be trained using ultrasound to assist spinal anaesthesia Receives: 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 Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful first spinal block attempt
Single skin puncture without redirection and with backflow of cerebrospinal fluid
Measured: During spinal blocks
Secondary outcomes (10)
Number of attempts
Number of skin punctures
Measured: During block
Number of redirections
Number of needle redirections
Measured: During block
Successful block for operation
Yes/no
Measured: During block
Need for supervisor's verbal help
Verbal guidance
Measured: during block
Need for supervisor's technical assistance
Manual procedural assistance
Measured: During block
Time spent
Duration to backflow of cerebrospinal fluid from the time of needle insertion
Measured: During block
Need for sedation during spinal anaesthesia placement
Yes/no
Measured: During block
Additional intervention required intraoperatively- unexpected general anaesthesia
Unexpected general anaesthesia-and if so, the reason
Measured: During block
Additional intervention required intraoperatively- need for sedation
- and if so, the reason
Measured: During block
Expected difficult access
Yes-if yes, why:
Measured: During block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426679
- Sponsor's protocol ID
- 25/50538
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07426679
- Acronym / sponsor ID
- 25/50538
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted spinal anaesthesia | Experimental | Procedure: Ultrasound-assisted spinal anaesthesiaParticipants will be trained using ultrasound to assist spinal anaesthesia |
| Manual palpation technique for spinal anaesthesia | Active comparator | Procedure: Control groupParticipants will be trained using standard methods of manual palpation technique for spinal anaesthesia |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Physicians will be included using the following inclusion criteria:
- Eligible patients will be those scheduled for elective lower limb surgery requiring spinal anaesthesia.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-assisted spinal anaesthesiaParticipants 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 or surgery | Ultrasound-assisted spinal anaesthesia |
| Control groupParticipants 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. | Procedure or surgery | Manual palpation technique for spinal anaesthesia |
Primary outcome
Successful first spinal block attempt
Time frame: During spinal blocks
Single skin puncture without redirection and with backflow of cerebrospinal fluid
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-assisted spinal anaesthesia in people with Ultrasound and Spinal Anaesthesia, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine Siw Nielsen,, M.D (+4520811044, Martine.Siw.Nielsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful first spinal block attempt (time frame: During spinal blocks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.