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CTRI Number  CTRI/2025/06/089248 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ultrasound Guided Epidural Depth assessment Between Transverse Median Plane and landmark approch And Parasagittal Oblique Plane and landmark approch For Lower Thoracic Epidural.  
Scientific Title of Study   Ultrasound Guided Epidural Depth Estimates : A Comparison Between Transverse Median Plane And Parasagittal Oblique Plane For Lower Thoracic Epidural 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitishree Tyagi 
Designation  Resident Anaesthesia 
Affiliation  Himalayan Institute of Medical Sciences  
Address  Department Of Anaesthesiology and pain management, SRHU HIMS, Jolly Grant Dehradun, 248140 India

Dehradun
UTTARANCHAL
248140
India 
Phone  9999722706  
Fax    
Email  drnitishree@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rohan Bhatia 
Designation  Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department Of Anaesthesiology and pain management, SRHU HIMS, Jolly Grant Dehradun, 248140 India

Dehradun
UTTARANCHAL
248140
India 
Phone  9971014232  
Fax    
Email  rohanbhatia@srhu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Rohan Bhatia 
Designation  Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department Of Anaesthesiology and pain management, SRHU HIMS, Jolly Grant Dehradun, 248140 India

Dehradun
UTTARANCHAL
248140
India 
Phone  9971014232  
Fax    
Email  rohanbhatia@srhu.edu.in  
 
Source of Monetary or Material Support  
Swami Rama Himalayan University Jolly Grant, Dehradun, 248140 
 
Primary Sponsor  
Name  Swami Rama Himalayan University 
Address  SRHU HIMS, Jolly Grant, Dehradun 248140, Uttrakhand, India 
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 
Rohan Bhatia  Swami Rama Himalayan Institute, HIMS  Department Of Anaesthesiology And Pain Management, Fisrt Floor, HIMS SRHU, Jolly Grant 248140 Dehradun, UK, India Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL 
9971014232

rohanbhatia@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SWAMI RAMA HIMALAYAN UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Parasagittal Oblique Plane  This is the newer or less conventional approach that is often considered as the intervention in comparative studies 
Comparator Agent  Transverse Median Plane  This is typically the standard or more commonly used technique, and hence serves as the comparator 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologist (ASA) physical status grade I and II posted for elective surgical procedures of general surgery, urological and gynaecological surgeries under lower thoracic epidural anaesthesia. 
 
ExclusionCriteria 
Details  Patient refusal for Regional Anaesthesia.
Known allergies to Local anaesthetics.
Bleeding disorders
Infection at local site
BMI above 30 kg/m2
Inability to give informed consent
Psychiatric Disorder
Patient with neurological diseases
History of spinal surgery
Pregnant females
Deformities of the spine and any other contraindication to neuraxial block will be excluded from this study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate skin epidural depth as assessed by ultrasound (UD) & conventional technique Needle depth (ND) in Transverse median plane & Parasagittal Oblique plane.  15-20 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the accuracy of needle depth (ND) and ultrasound guided epidural depth (ED) in Transverse median plane and Parasagittal oblique plane .
Correlation between Body Mass Index (BMI) and skin epidural depth in both the planes. 
15-20 minutes  
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/06/2025 
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 Applicable 
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  


Epidural analgesia is a form of regional analgesia which involving the drugs through   injection or a catheter placed in the epidural space.It is still considered as a gold standard for perioperative pain management in major abdominal and thoracic surgeries as it improves the postoperative outcome. Advantage includes a lower risk of postoperative myocardial infarction, better pulmonary mechanics and decreased hyper-coagulable reaction to stress which all lead to better recovery after surgery (1 ,2).Epidural analgesia through an indwelling catheter decreases intra and postoperative opioid usage (3). It has been observed that in Thoracic and Intra-abdominal surgeries the incidence of postoperative gastrointestinal dysfunction, sedation and respiratory depression were reduced with continuous Thoracic Epidural Analgesia (TEA).  TEA was linked to early ambulation, improved recovery throughout the peri-operative phase with decreased need of analgesia. TEA also promotes better control of neuroendocrine stress response in intraoperative phase due to protein catabolism and reduced insulin resistance hence aiding in better pain control management (4). It is difficult to access the Thoracic epidural space using the standard anatomic landmark-based Loss Of Resistance (LOR) technique because of spinous processes have a sharp caudal angle and the laminae are densely packed on top of one another , resulting in very limited inter laminar space. Therefore adopting the anatomic landmark based technique for thoracic epidural makes it technically more challenging.And it may leads to” multiple attempts and a relatively higher failure rate (12-40%) which  increases  patient discomfort and morbidity (5).Nowadays, ultrasound based localisation of the epidural space has become a popular teaching tool. Ultrasonography is useful in planning the insertion angle for the needle trajectory, seeing the anatomy and measuring the depth from the skin to the epidural space therefore it reduces the failure rate, improves learning curve and decrease puncture attempts (6).Ultrasound guided lumbar epidural has gained popularity as it is easily performed, provides opportunity to confirm the landmarks and deposit the local anaesthetic at correct place besides being associated with improved safety and decreased rate of complications. To visualise the lumbar epidural space Ultrasound imaging of the spine is performed in transverse axial plane at the level of desired intervertebral space (7).Use of thoracic epidurals for intra and postoperative analgesia for open abdominal surgeries has exponentially increased over the last decade mainly using conventional methods based on loss of resistance technique (8).Ultrasound guided epidural depth assessment has been primarily used for lumbar region (9). So far, the data on use of ultrasound guided assistance in Thoracic region for depth assessment in both transverse median plane and parasagittal oblique plane is very limited. Therefore, with this background we are planning to evaluate skin epidural depth assessment with conventional loss of resistance technique with ultrasound to assess the accuracy of ultrasound in both the planes.
 
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