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CTRI Number  CTRI/2024/07/070560 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   If by using ultrasonography the distance of transverse process and epidural space are similar to the actual depth of epidural space  
Scientific Title of Study   Relationship between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual depth of epidural space in adult patients – a prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rigzin Angmo Karpa 
Designation  PG resident  
Affiliation  Lady Hardinge Medical College  
Address  Department of Anesthesia/ Room 332/ House surgeon block/ lady Hardinge medical college
C4/111 Safdarjung development area. Hauz Khas
New Delhi
DELHI
110001
India 
Phone  7042809739  
Fax    
Email  angmorigzin07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Upma Bhatia Batra  
Designation  Professor  
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi

New Delhi
DELHI
110001
India 
Phone  9868616048  
Fax    
Email  ubhatia2004@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Upma Bhatia Batra  
Designation  Professor  
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi

New Delhi
DELHI
110001
India 
Phone  9868616048  
Fax    
Email  ubhatia2004@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Lady Hardinge Medical College New Delhi 110001 India  
 
Primary Sponsor  
Name  Lady Hardinge Medical College  
Address  Shaheed Bhagat singh Marg New Delhi 110001 India  
Type of Sponsor  Government 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 
Rigzin Angmo Karpa  Lady Hardinge Medical College and ass hospitals   Department of anaesthesia, shaheed Bhagat singh marg, 110001
Central
DELHI 
7042809739

angmorigzin07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research,LHMC and Assoc. Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) physical status I or II adult patients receiving epidural anaesthesia for elective surgery
 
 
ExclusionCriteria 
Details 
1 Obvious spine deformity
2 History of spine surgery
3 Infection at needle insertion site
4 Coagulopathy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Concordance correlation coefficient between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual depth of epidural space in adult patients  1 After removal of epidural needle 
 
Secondary Outcome  
Outcome  TimePoints 
1 Bias, precision and agreement between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual depth of epidural space in adult patients
2 Spearman coefficient between the depth of lumbar transverse process and needle insertion depth with the BMI of the patient.
3 Percentage of patients having successful first pass attempt.
4 Median Interquartile range (IQR) of ultrasound visualization score (UVS). 
1 After removal of epidural needle
2 After removal of epidural needle
3 After removal of epidural needle
4 During pre procedural ultrasonography of spine 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   25/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="18" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

       Ultrasound (US) guidance has revolutionized the practice of regional anaesthesia and its use in    

neuraxial anaesthesia has shown to improve the ease and accuracy of performance of neuraxial blocks. The routine use of US for neuraxial anesthesia was not formally accepted until 2008 when the National Institute for Health and Care Excellence recommended it for epidural catheterizations.1 Systematic examination of the spine sonoanatomy provides valuable anatomical information such as the identity of given vertebral level, the depth of epidural space and the location of midline of the interspinous and interlaminar spaces in sagittal and transverse planes. Various studies have found excellent correlation between the US estimated depth (UD) to the epidural space and the actual needle depth (ND) in transverse median (TM) and paramedian sagittal oblique (PSO) planes across variable patient populations.2,3 However, the US guided technique is not without its limitations. Imaging the vertebral canal in the US(ligamentum flavum, dura mater, and posterior aspect of the vertebral body) can be difficult in the same patient populations in which it is most requiredIn cases of obesity, spinal deformity or previous surgeries or instrumentation of the spine, oedema of the back; it becomes difficult to image various neural structures optimally.4

           Therefore, there is a need for establishing easily visible surrogate landmarks to guide towards depth assessment of epidural space especially for less experienced usersIn the lumbar region, anatomically the horizontal level of the transverse process corresponds to the level of the intervertebral space through which epidural and sub arachnoid spaces can be accessed.5 In the US guided transverse inter laminar view of the spine the transverse process and the articular process lie in approximately the same transverse plane as the posterior complex. So, measuring the depth of the posterior margin of transverse process from the skin surface may corroborate with the depth of the posterior complex from the skin, when the posterior complex is either not visualized or poorly visualized.In patients with difficult surface anatomical landmarks, visualization of sonoanatomy may also be difficult.6 So, there is a need to identify surrogate markers of neural structures that are relatively easy to image. At the lumbar level, the transverse process is one such landmark. We aimed to conduct the present study to estimate the relationship between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual needle depth of epidural space in adult patients which is the gold standard for epidural space depth measurement

 
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