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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-assisted spinal anaesthesia | Experimental | Participants will be trained using ultrasound to assist spinal anaesthesia |
|
| Manual palpation technique for spinal anaesthesia | Active Comparator | Participants will be trained using standard methods of manual palpation technique for spinal anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful first spinal block attempt | Single skin puncture without redirection and with backflow of cerebrospinal fluid | During spinal blocks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts | Number of skin punctures | During block |
| Number of redirections | Number of needle redirections | During block |
| 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 |
Inclusion Criteria:
Physicians will be included using the following inclusion criteria:
Eligible patients will be those scheduled for elective lower limb surgery requiring spinal anaesthesia.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martine Siw Nielsen,, M.D | Contact | +4520811044 | Martine.Siw.Nielsen@rsyd.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive care | Recruiting | Kolding | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2025 | Feb 16, 2026 |
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| 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. |
|
| 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 |
Post-- dural puncture headache, local infection or paraesthesia |
| From day 0 to day 7 |
| Martine Siw Nielsen | Not yet recruiting | Kolding | Denmark |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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