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CTRI Number  CTRI/2023/03/051215 [Registered on: 31/03/2023] Trial Registered Prospectively
Last Modified On: 29/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of spinal mannequin based teaching with conventional teaching for spinal anesthesia. 
Scientific Title of Study   Comparison of spinal mannequin based simulation teaching with conventional didactic method of teaching subarachnoid block in novices: A randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepanshu Dang 
Designation  Senior resident 
Affiliation  AIIMS JODHPUR 
Address  Department of anesthesiology and critical care , 3rd floor, emergency building, AIIMS Jodhpur
Basni industrial area
Jodhpur
RAJASTHAN
342005
India 
Phone  9820879556  
Fax    
Email  dangdeepanshu94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tanvi Meshram 
Designation  Assistant Professor 
Affiliation  AIIMS JODHPUR 
Address  Department of anesthesiology and critical care, 3rd floor emergency building, AIIMS Jodhpur
Basni industrial area
Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  tanvimeshram162@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tanvi Meshram 
Designation  Assistant Professor 
Affiliation  AIIMS JODHPUR 
Address  Department of anesthesiology and critical care, 3rd floor, emergency building, AIIMS Jodhpur
Basni industrial area
Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  tanvimeshram162@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesiology and critical care,AIIMS Jodhpur 
 
Primary Sponsor  
Name  Deepanshu Dang 
Address  AIIMS, Jodhpur 
Type of Sponsor  Other [Principal investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepanshu Dang  AIIMS Jodhpur  Department of anesthesiology and critical care,3rd floor emergency building, AIIMS ,Basni industrial area, 342005
Jodhpur
RAJASTHAN 
9820879556

dangdeepanshu94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Jodhpur Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional  Participants not trained on spinal mannequin but only recieved didactic teaching. 
Intervention  simulated Training  participants who are trained on spinal mannequin. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Novice post graduate students of Anaesthesiology 
 
ExclusionCriteria 
Details  Those who have previously observed or trained in neuraxial anaesthesia,or are not willing,or does not want to be assessed, will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
number of successful first attempt of spinal needle placement into subarachnoid space.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare total number of attempts for successful spinal needle placement
2.To compare number of needle-bone contacts
3.To compare ease of landmark palpation of space using Likert scale
4.To compare time taken to successfully perform subarachnoid block
5.To compare complications (dural puncture , vasovagal shock ,Bloody tap),
6.To compare able to appreciate give away/loss of resistance 
baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dangdeepanshu94@gmail.com].

  6. For how long will this data be available start date provided 31-03-2024 and end date provided 30-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - .
Brief Summary  

Neuraxial anaesthesia is the standard and reliable technique of intraoperative and postoperative pain relief for patients undergoing surgeries.Neuraxial anaesthesia is difficult to learn and takes many years to attain expertise. [1] The evidence for teaching the skills and knowledge necessary to be competent and safe in neuraxial anaesthesia is limited, despite clinical acceptance of the technique. United Kingdom department of health recommended that health professional should learn skills in simulation environment before undertaking them in supervised clinical practice. [2]Invitro models provide novice safe medium to correct errors, gain motor skills and allow time to develop proficiency before undertaking procedures on patients. Many types of phantoms are available including water, tofu, beef gravy, gelatin, elastomeric rubber, turkey, beef, pork and fresh and embalmed cadavers. Each of these models has advantages and disadvantages in terms of fidelity, cost and availability.[3]The transformation from an unstructured and unsystematic approach to a more structured approach to teach procedural skills is much needed ,it is unethical for novices at any level of training to practice new skills on patients even if they have patients explicit consent. There are fewer opportunities to learn on patients due to a decreased tolerance for medical error and increased reluctance to accept risk to patients from learners. The ethics of learning on patients with inanimate alternatives are readily available, and hence exposing both patient and learner to avoidable risk. [4]In a study by Vander Wielen et al. , participants who viewed a brief instructional video  improved their ability to acquire ultrasound images and identify anatomical landmarks on a live model. However, a group randomized to a hands-on training session with an anatomy-based gel phantom (scanning session did not exceed ten minutes) was more successful than the video group in identifying anatomical landmarks when both were compared to a control group, reinforcing the value of handson experience and dynamic image interpretation to learn sonoanatomy.[5]Conventional didactic methods of learning where anaesthesia residents after observing a specific number of procedures under educator guidance when tried to perform the procedures faced many difficulties and their success dependent on many technical and non-technical factors. Performing neuraxial anaesthesia by conventional observational methods can be technically difficult and demand some amount of expertise and experience. Relying on individuals limited experience alone can lead to incorrect identification of the targeted epidural space. furthermore, without knowledge of anatomy and correct interpretation of sonoanatomy, novices can fail to recognize abnormal anatomy and may endanger patients with inadvertent dural puncture. This may also result in increased procedural time, multiple needle passes, unstable needle movements, patient discomfort and inadequate neuraxial blockade. Simulated training can be a valuable tool for acquiring knowledge and skills, gaining hands-on experience through repetitive practice of salient aspects of a procedure and provide some sensory feedback without harm to patients, and receiving individualized feedback. Declining learning opportunities in clinical practice and the need to maximize patient  safety dictate that cognitive and integrative stage should occur before learners practice on patients. [7]One area of uncertainty is the choice of the best model or phantom to teach ultrasound‐guided neuraxial anaesthesia technical skills. The rationale for training using in‐vitro models is to provide novices with a safe medium to correct errors, gain motor skills and allow time to develop proficiency before undertaking procedures on patients. Lots of efforts are ongoing in examining the different components of the UGRA and many teaching methods have been used without fully researching their effectiveness. Only few studies are available on head to head comparison on different teaching models. Hence, we designed this study to determine if there was any advantage in using blue phantom spinal epidural model when training novices to perform neuraxial anaesthesia.

 
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