FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/012133 [Registered on: 23/02/2018] Trial Registered Retrospectively
Last Modified On: 02/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does a Pre-Procedural Ultrasound Of the spine Improve The Performance For Spinal Anaesthesia 
Scientific Title of Study   Efficacy Of Pre-Procedural Ultrasound Of Lumbar Spine In Improving The Procedural Skill For Subarachnoid Block 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  P R Arthi 
Designation  Post Graduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pillaiyarakuppam Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone    
Fax    
Email  arthi.pre@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Archana Areti 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pillaiyarakuppam Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone    
Fax    
Email  archanaareti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Archana Areti 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pillaiyarakuppam Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone    
Fax    
Email  archanaareti@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute Pillaiyarakuppam Puducherry - 607402 
 
Primary Sponsor  
Name  Department Of Anaesthesiology 
Address  Mahatma Gandhi Medical College and research Institute Pillaiyarakuppan Puducherry 
Type of Sponsor  Private medical college 
 
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 
Archana Areti  Mahatma Gandhi Medical College and Research Institute  Department of anaesthesiology Pillaiyarakuppam Puducherry
Pondicherry
PONDICHERRY 
8374237095

archanaareti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients posted for elective surgery under spinal anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LM   Landmark based technique of Spinal Anaesthesia 
Intervention  US  USG scanning and skin marking of the lumbar spine prior to performing spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA Grade I and II 
 
ExclusionCriteria 
Details  1) patient refusal
2) Contraindication for spinal anaesthesia – infection at site, coagulopathy, allergy to local anaesthetics
3) Spinal Deformity
4) BMI>35, Pregnancy
5) Previous Spine Surgery
6) Lower Limb Fractures
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
procedural success in first needle pass   procedural success in first needle pass  
 
Secondary Outcome  
Outcome  TimePoints 
number of needle passes   the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin 
The number of attempts defined as the number of times the spinal needle is withdrawn from the skin and reinserted  defined as the number of times the spinal needle is withdrawn from the skin and reinserted
A maximum of 3 attempts will be allowed for the performer. After 3 attempts, it will be considered as a procedural failure, following which the Senior anaesthesiologist will intervene 
The time taken to detect CSF   time from first needle insertion till CSF detection 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 14/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="4"
Days="4" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Spinal anaesthesia is one of the commonest procedures performed, and one of the first skills to be acquired by an anaesthesiologist.  It requires considerable skill, and demands a precise and total understanding of regional anatomic relationships.  Acquiring adequate knowledge of the anatomy and orientation of central neuraxis, for performance of a successful block, is still largely based on the “blind” landmark based procedure.  Radiological examination and simulation based training techniques have been employed successfully, to better aid the teaching process.

In recent times, Ultrasonography has shed light in various aspects in clinical anaesthesia, and has proven to be a useful tool for point of care procedures.  Pertaining to central neuraxial blockade, USG guided procedures have been proven to identify and navigate the difficult anatomy, but because the procedure is time taking and there pose some difficulty in obtaining clear images, it is not routinely used in clinical practise.  However in a setting where practise makes perfect, to include its application as a teaching tool for the normal anatomy, may prove to improve the technique of lumbar puncture for spinal anaesthesia in normal as well as difficult anatomy, thereby reducing the distress experienced by the patient with multiple attempts at spinal anaesthesia, also reducing incidence of associated complications (e.g hematoma, post dural puncture headache) .  This study is designed to evaluate if a preprocedural ultrasonographic examination of the lumbar spine, improves the performance of lumbar puncture for spinal anaesthesia.

 
Close