Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study
Phase: NA
Conditions: Ultrasound, Spinal Anaesthesia, Simulation Based Medical Education
Sponsor: University of Southern Denmark

 
Protocol 
 
Should anaesthesiologists be taught to perform ultrasound-assisted neuraxial 
access in spinal anaesthesia? – Protocol of a randomised controlled study  
 
Martine Siw Nielsen1,2,3, Lars Konge2,4, Anders Bo Nielsen2,5, Anders Grejs6,7, Anne Craveiro 
Brøchner1,3  
 
1 Department of Anaesthesiology and Intensive Care, Lillebaelt University Hospital, Kolding, 
Denmark 
2 Research Unit of Medical Education, Department of Clinical Research, University of Southern 
Denmark  
3 Department of Regional Health Research, Region of Southern Denmark 
4 Copenhagen Academy for Medical Education and Simulation, Center for HR & Education, The 
Capital Region of Denmark, Copenhagen, Denmark 
5 Department of Anesthesiology and Intensive Care, Odense University Hospital, Svendborg, 
Denmark 
6 Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark 
7 Department of Clinical Medicine, Aarhus University, Aarhus, Denmark 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Corresponding author: 
Martine Siw Nielsen, M.D. 
Sygehusvej 24 
DK-6000 Kolding 
Denmark 
Tel: +45 20 81 10 44 
Email: Martine.Siw.Nielsen@rsyd.dk 
16th July 2025

Abstract 
 
Background 
Neuraxial blockade, typically guided by manual palpation, can be challenging in certain patient 
populations. Ultrasound-assisted neuraxial access has the potential to improve success rates, 
particularly for novice anaesthesiologists, though structured training programs in this technique are 
limited.  
 
Methods 
This multicentre, randomised controlled trial will evaluate the use of ultrasound-assisted neuraxial 
block, following a simulation-based training programme based on the mastery-learning 
approach. Participants, consisting of novice and senior anaesthesiologists, will receive training in 
either ultrasound-assisted or traditional manual palpation techniques. Performance will be assessed 
in a clinical setting during elective lower limb surgery.  Statistical analyses will compare the clinical 
outcomes of ultrasound-assisted versus manual palpation techniques.  
 
Results 
The primary outcome is the success rate of the first spinal block attempt. Secondary outcomes include 
the number of attempts, needle redirections, time spent, and the need for additional interventions. 
Patient satisfaction and complications will be evaluated as tertiary outcomes.  
 
Conclusion 
This study may present the potential impact of a structured training program on anaesthesiologists' 
skills in ultrasound-assisted neuraxial access and potentially lead to better patient outcomes. By 
comparing ultrasound-assisted techniques with traditional manual palpation, the findings may lead to 
improvements in training methods and ultrasound-assisted approaches for neuraxial access. 
 
 
 
 
 
 
 
 
 
 

Introduction 
 
Neuraxial blockade is traditionally performed using a manual palpation technique to locate the 
optimal injection site.1 The procedure can be challenging, especially in patients with a high body mass 
index (BMI), pregnant patients, and patients with spinal deformities.2,3 When the manual palpation 
technique fails, using ultrasound to guide access may prove helpful.4 
 
A 2021 guideline presented by the European Society of Anaesthesiology and Intensive Care based on 
a review of randomised controlled trials and cohort studies recommended the use of preprocedural 
ultrasound scanning to provide better accuracy in identifying the intended intervertebral space -
however, with a weak recommendation due to a sparse amount of evidence.5 Additionally, the 
guideline specifically advises physicians in anaesthesia speciality training to use preprocedural 
ultrasound scanning to reduce skin punctures, suggesting a potential link to improved clinical 
outcomes, especially for novices.5 This recommendation aligns with a previous study suggesting that 
early ultrasound training could be particularly beneficial for novices. As demonstrated in the context 
of epidural anaesthesia, the incorporation of preprocedural ultrasound imaging may reduce 
complications and improve success rates.6 Although ultrasound seems to offer an advantage in patient 
care, it is sparsely used in clinical practice. A recognised challenge is the lack of structured training 
in the technique.7,8 Previous studies focusing on training in traditional neuraxial anaesthesia map out 
the required amount of training through learning curves. However, this approach may limit optimal 
use, as significant inter-individual variability in learning curves has been demonstrated.6,9-16 These 
training programs, with fixed durations based on time or number of procedures, fail to account for 
individual differences in skills acquisition.17 An alternative to this is mastery learning, which aims to 
ensure a predefined performance standard through repeated practice until a standard level is 
reached.18 A final test ensures that every trainee reaches the same level of competency, regardless of 
their learning pace by ensuring clear objectives for trainees assessed by fixed standards and 
measurements.18,19  
 
However, to the best of our knowledge, no studies have explored the clinical benefits and patient 
satisfaction for patients of both novice and more experienced anaesthesiologists following a 
structured training programme in ultrasound-assisted neuraxial access. 
 
Aim 

This study aims to investigate whether anaesthesiologists using ultrasound-assisted spinal block have 
better patient outcomes and satisfaction than anaesthesiologists using the traditional manual palpation 
technique. Additionally, the study will evaluate the relevance of prior clinical experience. 
 
Methods 
Setting 
This multicentre randomised controlled trial will take place in simulation centres and clinical 
departments.   
Simulation-based training will be conducted in simulation centres or local departments, where 
physicians working in anaesthesia will practice ultrasound-assisted or manual palpation neuraxial 
access under controlled conditions, ensuring a standardised learning environment. Clinical 
performance will be assessed at hospitals across Denmark during elective lower limb surgery to 
ensure controlled and comparable conditions.  
 
Participants 
Participants will be either novices (first-year anaesthesia residents recruited early in their training 
program) or seniors (physicians in their specialist training or specialist-trained anaesthesiologists). 
Novices will be recruited based on the required sample size, while seniors will be recruited as a 
convenience sample. Data on participants' demographics will be collected, including age, sex at birth, 
months of anaesthesia experience, and the number of neuraxial accesses performed with and without 
ultrasound. 
 
Eligible criteria – Physicians  
Physicians will be included using the following inclusion criteria:  
1) Physicians working in anaesthesia 
2) Opportunity to use the spinal block technique within two weeks of the training session.   
Exclusion criteria will be previous structured education in ultrasound-assisted neuraxial access. 
 
Eligible criteria – Patients 
Eligible patients will be those scheduled for elective lower limb surgery requiring spinal 
anaesthesia. Patient demographics, including age, height, weight, history of back surgery, or other 
known spinal pathologies, will be recorded. Patients will be informed about the study's purpose and 

contacted by phone within a week post-procedure to complete a follow-up questionnaire focusing 
on satisfaction and complications. 
Exclusion criteria: Patients under 18 years of age. 
 
Randomisation 
For the primary outcome, participants, being novices in anaesthesia, will be randomly assigned to 
either the intervention group or the control group using block randomisation with randomly selected 
block sizes. The randomisation list will be created using an integrated random number service offered 
by the secure platform Research Electronic Data Capture (REDCap) hosted by the Open Patient Data 
Explorative Network (OPEN).20 The randomisation will be revealed at the creation of a new 
participant ID during the inclusion session, and consequently, the randomisation sequence will not be 
accessible to anyone involved in the study before the inclusion of the participant.  
For the secondary outcome, the senior anaesthesiologists will rely on a convenience sample and 
randomisation to either group. 
 
Structured training intervention 
Education and training – intervention group – ultrasound-assisted access  
Physicians in the intervention group will receive a video-based theoretical introduction to ultrasound-
assisted neuraxial access, focusing on sonographic anatomy, technical aspects, approach to common 
problems, complications, and contraindications. This video-based theoretical session will be available 
to participants during the study period.  
 
Following the theoretical curriculum, a simulation-based ultrasound-assisted neuraxial hands-on 
training on a low-fidelity phantom (CAE Blue Phantom Lumbar Puncture And Spinal And Epidural 
Ultrasound Training Model (CAE Healthcare, Montréal, Canada) will be conducted. There will be no 
time limit for completion, adhering to the mastery-learning approach. As a part of the training, 
participants will complete a post-training test recorded on a tablet, with only their hands and the low-
fidelity phantom visible. These tests will be evaluated by an experienced physician. Participants must 
pass the post-training test to be certified, ensuring a minimum baseline before patient involvement. 
After training, the participants will be asked to fill out a questionnaire based on the Intrinsic 
Motivation Inventory (IMI) scale to assess their motivation and engagement with the activity.21 The 

IMI items will consist of six chosen statements.  Each statement will be rated on a 7-point Likert 
Scale, where 1 is “Not true at all”, 4 is “Somewhat true”, and 7 is “Very true”.  
 
Education and training – control group – manual palpation technique 
Physicians in the control group will receive a video-based theoretical introduction to neuraxial access 
using manual palpation. As manual palpation training for spinal blocks is mandatory early in the first 
year of employment, the video serves as a refresher. The curriculum covers technical aspects, 
approaches to common challenges, complications, and contraindications. This is followed by 
simulation-based neuraxial hands-on training on a low-fidelity phantom (CAE Blue Phantom Lumbar 
Puncture and Spinal and Epidural Ultrasound Training Model, CAE Healthcare, Montréal, Canada). 
Both the theoretical and practical training are adapted from a well-established simulation-based 
lumbar puncture curriculum. Participants must pass the post-training test, using the LumPAT 
assessment tool, which has established validity evidence in a similar simulation-based setting.22 After 
training, the participants will be asked to evaluate the training using the Intrinsic Motivation Inventory  
(IMI) Scale, like in the intervention group.21  
 
Clinical testing of groups 
After certification, physicians will perform either ultrasound-assisted neuraxial access or traditional 
manual palpation neuraxial access during their first two planned lower limb surgeries, with live 
evaluations conducted by a senior specialist-trained anesthesiologist, with experience in the 
procedures, using clinical metrics. Before clinical performance, participants will receive a short just-
in-time brush-up training, where feasible. All participants will have access to a brush-up video and 
will be strongly encouraged to see it before clinical performance.  
Furthermore, patients will answer a follow-up questionnaire via phone within a week (Appendix 1), 
and answers will be stored in a secure RedCap database.20 
 
Outcomes (Appendix 1) 
Participants will be assessed in the clinical setting using predefined metrics, with real-time 
evaluations from a senior colleague. 
The primary outcome will be a successful first spinal block attempt.  

Secondary outcomes will include the number of attempts, number of needle redirections, successful 
block, need for supervisor’s verbal or procedural assistance, time spent, additional intervention 
required intraoperatively, and if the physician expected the access to be difficult, and why.  
Patients’ satisfaction and complications will be a tertiary outcome.  
 
Sample size calculation 
The sample size was calculated to detect a significant difference between two proportions using 
Stata's power two proportions command. The expected proportions in the two groups were based on 
a previous study, examining the ultrasound-assisted technique in spinal anesthesia compared to the 
paramedian manual palpation technique in elderly undergoing orthopaedic surgery.23 The first pass 
success rate was 65% in the ultrasound-assisted group compared to 17.5% in the landmark group.23 
The Fisher’s exact test was used with a 5% significance level (α = 0.05) and 80% statistical power, 
requiring a total sample size of 36 participants (18 per group) to detect a difference. To account for 
an anticipated 10% dropout rate, the sample size will be increased to 40 participants (20 per group), 
ensuring sufficient power to test the null hypothesis that the two proportions are equal, even with 
dropouts. 
 
Statistical analyses 
Demographic data of physicians and patients will be presented, analysed, and summarised using a 
descriptive approach. Fisher’s exact test will be performed to compare outcomes for successful first 
spinal block attempts between ultrasound-assisted procedures versus manual palpation techniques. 
For secondary outcomes of continuous variables, including the number of attempts, number of 
redirections, and time spent comparisons will be conducted using t-tests for normally distributed data 
and Mann Whitney test for non-normally distributed data. For binary categorical variables, such as 
the need for a supervisor’s help (verbal or technical), and the need for additional interventions (e.g. 
general anaesthesia) Fisher’s exact test will be used. Patients’ perceptions will be summarised in a 
descriptive form and the complications in the two groups will be compared using Fisher’s exact test. 
McNemar’s will be performed to compare the first and second performed procedures. All analyses 
will be performed using statistical software, and results will be considered at a significance level of 
p < .05.  
 
Ethics 

Written informed consent will be obtained from all study physicians and patients.  Participation is 
voluntary and withdrawal from the study may be commenced at any time with no repercussions. MSN 
and ACB will have access to information about the participants and patients’ associated data. All data 
will be entered and handled in an online database: Research Electronic Data Capture (REDCap). An 
application will be sent to the Internal Research Register in the Region of Southern Denmark. 
Likewise, a notification will be sent to the Research Ethics Committee at the University of Southern 
Denmark.  
 
Discussion 
This study aims to add knowledge to the literature, presenting clinical outcomes for anesthesiologists 
using ultrasound in neuraxial access, following a simulation-based mastery learning programme 
offering an alternative to traditional apprenticeship.24-28 Despite a positive consensus of using 
simulation-based training to enhance patient safety, a limited number of studies have focused on 
developing curricula in anaesthesia. Most existing research centres on central venous catheter 
insertion, demonstrating a reduction in complications.29-31 Studies on neuraxial block skills similarly 
show positive outcomes from simulation-based training, but the number of studies remains limited.32  
 
A central strength of our study is that it is based on the mastery-learning approach. Mastery learning 
ensures that all trainees achieve a certain level of skills by setting a predefined performance 
standard.18 The approach includes a final test that ensures that every trainee reaches the same level of 
competency, regardless of their learning pace, by providing clear objectives to trainees assessed by 
fixed standards and measurements.18,19 Mastery learning has proven valuable in skills training, as it 
helps reduce errors and improve patient safety. 31,33  
 
In addition to addressing individual competencies, this study evaluates training outcomes across all 
four levels of Kirkpatrick’s evaluation model (Table 1).34 Including all four levels is important for 
understanding not only the immediate subjective reaction of the learner but also whether the training 
leads to improvement in skills, clinical performance, and ultimately patient outcomes. Measuring 
across all four levels, provides a more comprehensive understanding of the value of the training and 
helps identify areas for potential improvement in the curriculum.  Furthermore, an essential part of 
this study is the use of outcome measurements, for which validity evidence has been established, 
including both the LumPat assessment tool and the IMI.21,22 Establishing validity is important because 

it provides a foundation for interpreting the results accurately, and ensures that the measures are 
appropriate for the constructs being studied. Additionally, the patient outcome measures used have 
been applied in previous studies, which supports their relevance in this context.  
 
Limitations 
This study has several limitations. First, the inclusion of senior anaesthesiologists via convenience 
sampling may introduce selection bias, as participants with either a strong interest in ultrasound may 
self-select to participate. Additionally, relying on a convenience sample for senior anaesthesiologists 
may result in an underpowered comparison between novice and senior participants, potentially 
making it difficult to detect meaningful differences. Clinical performance assessments are based on 
the judgment of senior anaesthesiologists, whose evaluations may be subject to subjective biases or 
inconsistencies, potentially affecting the reliability and objectivity of the outcomes.35 Another 
limitation is the potential for recall bias in patient-reported outcomes. However, by contacting patients 
within a week of the procedure, we aim to minimise this issue. 
 
Conclusion 
This study presents the potential impact of a structured training program on anaesthesiologists' skills 
in ultrasound-assisted neuraxial access and potentially lead to better patient outcomes. By comparing 
ultrasound-assisted techniques with traditional manual palpation, the findings could lead to 
improvements in training methods and ultrasound-assisted approaches for neuraxial access for 
novices as well as for experienced anesthesiologists. 
 
Author contribution 
MSN, ACB, ABN, LK, and AMG conceived the study. MSN and ACB drafted the manuscript. ABN, 
AMG, and LK all provided critical revisions to the manuscript. All authors read and approved the 
final version of the manuscript.  
 
Funding information  
There has been no financial support for this work, which could have influenced its outcome.  
 
Conflicts of interest 
We wish to confirm there are no conflicts of interest associated with this article.  

Data availability statement 
The data that support the findings of this study are available from the corresponding author upon 
reasonable request.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

References 
1. 
Lirk P, El-Boghdadly K. Using ultrasound for nerve blocks and neuraxial anaesthesia: The 
PERSEUS guidelines. European Journal of Anaesthesiology | EJA 2021;38(3):215-218. 
DOI: 10.1097/eja.0000000000001422. 
2. 
Mace HS, Paech MJ, Mcdonnell NJ. Obesity and Obstetric Anaesthesia. Anaesthesia and 
Intensive Care 2011;39(4):559-570. DOI: 10.1177/0310057x1103900410. 
3. 
Ružman T, Gulam D, Haršanji Drenjančević I, Venžera-Azenić D, Ružman N, Burazin J. 
Factors associated with difficult neuraxial blockade. Local Reg Anesth 2014;7:47-52. (In 
eng). DOI: 10.2147/lra.S68451. 
4. 
Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural 
Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med 
2016;41(2):251-60. (In eng). DOI: 10.1097/aap.0000000000000184. 
5. 
Boselli E, Hopkins P, Lamperti M, et al. European Society of Anaesthesiology and Intensive 
Care Guidelines on peri-operative use of ultrasound for regional anaesthesia (PERSEUS 
regional anesthesia): Peripheral nerves blocks and neuraxial anaesthesia. European Journal 
of Anaesthesiology | EJA 2021;38(3):219-250. DOI: 10.1097/eja.0000000000001383. 
6. 
Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves 
learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth 
2003;50(10):1047-50. (In eng). DOI: 10.1007/bf03018371. 
7. 
Bessmann EL, Østergaard HT, Nielsen BU, et al. Consensus on technical procedures for 
simulation‐based training in anaesthesiology: A Delphi‐based general needs assessment. 
Acta anaesthesiologica Scandinavica 2019;63(6):720-729. (In English). DOI: 
10.1111/aas.13344. 
8. 
Mathieu S, Dalgleish DJ. A survey of local opinion of NICE guidance on the use of 
ultrasound in the insertion of epidural catheters. Anaesthesia 2008;63(10):1146-7. (In eng). 
DOI: 10.1111/j.1365-2044.2008.05697.x. 
9. 
Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia "learning curve". What is the 
minimum number of epidural and spinal blocks to reach consistency? Reg Anesth 
1996;21(3):182-90. (In eng). 
10. 
Konrad C, Schupfer G, Wietlisbach M, Gerber H. Learning Manual Skills in 
Anesthesiology: Is There a Recommended Number of Cases for Anesthetic Procedures? 
Anesthesia & Analgesia 1998;86(3):635-639. DOI: 10.1213/00000539-199803000-00037. 
11. 
Naik VN, Devito I, Halpern SH. Cusum analysis is a useful tool to assess resident 
proficiency at insertion of labour epidurals. Can J Anaesth 2003;50(7):694-8. (In eng). DOI: 
10.1007/bf03018712. 
12. 
Guasch E, Díez J, Gilsanz F. [Monitoring skill acquisition in obstetric epidural puncture at a 
university hospital using the cumulative sum method]. Rev Esp Anestesiol Reanim 
2010;57(1):11-5. (In spa). DOI: 10.1016/s0034-9356(10)70157-2. 
13. 
Ospina ODA, Medina ÁMR, Marulanda MC, Buitrago LMG. Cumulative Sum learning 
curves (CUSUM) in basic anaesthesia procedures. Colombian Journal of Anesthesiology 
2014;42(3):142-153. (10.1016/j.rcae.2014.04.005). DOI: 10.1016/j.rcae.2014.04.005. 
14. 
Drake EJ, Coghill J, Sneyd JR. Defining competence in obstetric epidural anaesthesia for 
inexperienced trainees. Br J Anaesth 2015;114(6):951-7. (In eng). DOI: 10.1093/bja/aev064. 
15. 
Weil G, Motamed C, Biau DJ, Guye ML. Learning curves for three specific procedures by 
anesthesiology residents using the learning curve cumulative sum (LC-CUSUM) test. 
Korean J Anesthesiol 2017;70(2):196-202. (In eng). DOI: 10.4097/kjae.2017.70.2.196. 
16. 
Lew E, Allen JC, Jr., Goy RWL, Ithnin F, Sng BL. Determining competence in performing 
obstetric combined spinal-epidural procedures in junior anesthesiology residents: results 

from a cumulative sum analysis. Int J Obstet Anesth 2020;44:33-39. (In eng). DOI: 
10.1016/j.ijoa.2020.05.002. 
17. 
Mahmood O, Jørgensen R, Nielsen K, Konge L, Russell L. Hands-On Time in Simulation-
Based Ultrasound Training - A Dose-Related Response Study. Ultrasound Int Open 
2022;8(1):E2-e6. (In eng). DOI: 10.1055/a-1795-5138. 
18. 
Griswold-Theodorson S, Ponnuru S, Dong C, Szyld D, Reed T, McGaghie WC. Beyond the 
simulation laboratory: a realist synthesis review of clinical outcomes of simulation-based 
mastery learning. Acad Med 2015;90(11):1553-60. (In eng). DOI: 
10.1097/acm.0000000000000938. 
19. 
McGaghie WC. Mastery Learning: It Is Time for Medical Education to Join the 21st 
Century. Academic Medicine 2015;90(11):1438-1441. DOI: 
10.1097/acm.0000000000000911. 
20. 
Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international 
community of software platform partners. Journal of Biomedical Informatics 
2019;95:103208. DOI: https://doi.org/10.1016/j.jbi.2019.103208. 
21. 
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, 
social development, and well-being. Am Psychol 2000;55(1):68-78. (In eng). DOI: 
10.1037//0003-066x.55.1.68. 
22. 
Henriksen MJV, Wienecke T, Thagesen H, et al. Assessment of Residents Readiness to 
Perform Lumbar Puncture: A Validation Study. J Gen Intern Med 2017;32(6):610-618. (In 
eng). DOI: 10.1007/s11606-016-3981-y. 
23. 
Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-
guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J 
Anaesthesiol 2019;36(10):763-771. (In eng). DOI: 10.1097/eja.0000000000001029. 
24. 
Barsuk JH, McGaghie WC, Cohen ER, Balachandran JS, Wayne DB. Use of simulation-
based mastery learning to improve the quality of central venous catheter placement in a 
medical intensive care unit. J Hosp Med 2009;4(7):397-403. (In eng). DOI: 
10.1002/jhm.468. 
25. 
Wilcox JE, Harap RS, Stosor V, et al. Effect of Ventricular Assist Device Self-care 
Simulation-Based Mastery Learning on Driveline Exit Site Infections: A Pilot Study. J 
Cardiovasc Nurs 2022;37(3):289-295. (In eng). DOI: 10.1097/jcn.0000000000000824. 
26. 
Schwab B, Teitelbaum EN, Barsuk JH, Soper NJ, Hungness ES. Single-stage laparoscopic 
management of choledocholithiasis: An analysis after implementation of a mastery learning 
resident curriculum. Surgery 2018;163(3):503-508. (In eng). DOI: 
10.1016/j.surg.2017.10.006. 
27. 
Feinsmith SE, Amick AE, Feinglass JM, et al. Performance of peripheral catheters inserted 
with ultrasound guidance versus landmark technique after a simulation-based mastery 
learning intervention. J Vasc Access 2023;24(4):630-638. (In eng). DOI: 
10.1177/11297298211044363. 
28. 
Barsuk JH, Cohen ER, Vozenilek JA, O'Connor LM, McGaghie WC, Wayne DB. 
Simulation-based education with mastery learning improves paracentesis skills. J Grad Med 
Educ 2012;4(1):23-7. (In eng). DOI: 10.4300/jgme-d-11-00161.1. 
29. 
Barsuk JH, Cohen ER, Feinglass J, McGaghie WC, Wayne DB. Use of simulation-based 
education to reduce catheter-related bloodstream infections. Arch Intern Med 
2009;169(15):1420-3. (In eng). DOI: 10.1001/archinternmed.2009.215. 
30. 
Barsuk JH, McGaghie WC, Cohen ER, O'Leary KJ, Wayne DB. Simulation-based mastery 
learning reduces complications during central venous catheter insertion in a medical 
intensive care unit. Crit Care Med 2009;37(10):2697-701. (In eng). 

31. 
Cohen ER, Feinglass J, Barsuk JH, et al. Cost savings from reduced catheter-related 
bloodstream infection after simulation-based education for residents in a medical intensive 
care unit. Simul Healthc 2010;5(2):98-102. (In eng). DOI: 10.1097/SIH.0b013e3181bc8304. 
32. 
Udani AD, Macario A, Nandagopal K, Tanaka MA, Tanaka PP. Simulation-based mastery 
learning with deliberate practice improves clinical performance in spinal anesthesia. 
Anesthesiol Res Pract 2014;2014:659160. (In eng). DOI: 10.1155/2014/659160. 
33. 
Barsuk JH, Cohen ER, Potts S, et al. Dissemination of a simulation-based mastery learning 
intervention reduces central line-associated bloodstream infections. BMJ Qual Saf 
2014;23(9):749-56. (In eng). DOI: 10.1136/bmjqs-2013-002665. 
34. 
Kirkpatrick DL. The Four Levels of Evaluation. In: Brown SM, Seidner CJ, eds. Evaluating 
Corporate Training: Models and Issues. Dordrecht: Springer Netherlands; 1998:95-112. 
35. 
Konge L, Vilmann P, Clementsen P, Annema JT, Ringsted C. Reliable and valid assessment 
of competence in endoscopic ultrasonography and fine-needle aspiration for mediastinal 
staging of non-small cell lung cancer. Endoscopy 2012;44(10):928-33. (In eng). DOI: 
10.1055/s-0032-1309892. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Tables  
 
Table 1, Kirkpatrick levels and assessment plans.  This table outlines the four levels of the Kirkpatrick 
model used to evaluate the effectiveness of the training program, including how each level is assessed 
and the methods used to measure outcomes.  
 
Kirkpatrick level 
Description 
Plan 
1: Reaction 
Reaction measures the degree to which 
participants find the program or 
initiative favourable, engaging and 
relevant to them. 
The Intrinsic Motivation Inventory 
(IMI) assesses participants' motivation 
after training, with participants 
evaluating their experience using a 6-
item IMI scale. 
2:  Learning 
 
Learning measures the degree to which 
participants acquire the intended 
knowledge, skills, attitude, confidence, 
and commitment based on their 
participation in the program.  
The simulation-based training, 
following the theoretical curriculum, 
includes a post-training test that is 
evaluated. 
3: Behaviour 
 
Behaviour measures the degree to 
which participants apply what they 
learned during the program or initiative 
when they are back in their 
environment. 
Participants will be assessed in the 
clinical setting with real-time 
evaluations from a senior colleague, 
focusing on the application of skills.  
4: Results 
 
Results measure the degree to which 
targeted organizational outcomes occur 
as a result of the initiative.  
Patients' satisfaction and 
complications will be measured.  
 
 
 
 
 
 
 

Appendix 
Appendix 1 – outcomes  
 
Outcome 
Definition 
Primary outcome 
Successful first spinal block attempt 
Single skin puncture without redirection and with 
backflow of cerebrospinal fluid 
Secondary outcomes – clinical metrics 
Number of attempts 
Number of skin punctures  
Number of redirections 
Number of needle redirections 
Successful block for operation 
Yes/no 
Need for supervisor’s verbal help 
Verbal guidance 
Need for supervisor’s technical assistance 
Manual procedural assistance  
Time spent 
Duration to backflow of cerebrospinal fluid from 
the time of needle insertion 
Need for sedation during spinal anaesthesia 
placement 
Yes/no  
Additional intervention required intraoperatively - 
unexpected general anaesthesia 
Unexpected general anaesthesia – and if so, the 
reason 
o Insufficient block 
o Longer surgery than expected  
o Patient comfort 
o Intraoperative complications (such as 
bleeding or cardiovascular instability) 
o Other (if so, what)  

Additional intervention required intraoperatively – 
need for sedation 
– and if so, the reason 
o Pain 
o Longer surgery than expected  
o Patient comfort (physical or emotional 
discomfort e.g. anxiety or distress)  
o Patient’s preferences (request from patient, 
regardless of any immediate discomfort) 
Other (if so, what) 
Expected difficult access 
No 
Yes – if yes, why: 
o Patient cooperation difficulties 
o Spinal deformities 
o Previous spinal surgeries 
o High BMI 
o Other (please elaborate) 
Tertiary outcomes – patient related outcomes 
Satisfaction 
o Periprocedural pain score (0, no pain; 10, 
worst pain imaginable) 
o Periprocedural discomfort (0, no discomfort; 
10, worst discomfort imaginable) 
o Satisfaction in general (very satisfied, 
satisfied, or dissatisfied) 
Complications from procedure day to day 7 
Post-dural puncture headache, local infection or 
paraesthesia