FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090737 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
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   Preprocedural USG guided Epidural block vs Conventional Anatomical landmark guided Epidural Block 
Scientific Title of Study   The impact of preprocedural ultrasound on identification,success rate and outcomes in epidural block: Prospective randomisation control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Dubey 
Designation  Major(Dr) 
Affiliation  Army Hospital Referral and Research 
Address  Department of Anaesthesiology and critical care,Army Hospital Research and Referral,Delhi Cantt,New Delhi

New Delhi
DELHI
110010
India 
Phone  9315618564  
Fax    
Email  poojaanildubey@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aditya Joshi 
Designation  Colonel(Dr) 
Affiliation  Army Hospital Referral and Research 
Address  Department of Anaesthesiology and critical care,Army Hospital Research and Referral,Delhi Cantt,New Delhi

New Delhi
DELHI
110010
India 
Phone  8854932130  
Fax    
Email  majoraditya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aditya Joshi 
Designation  Colonel(Dr) 
Affiliation  Army Hospital Referral and Research 
Address  Department of Anaesthesiology and critical care,Army Hospital Research and Referral,Delhi Cantt,New Delhi

New Delhi
DELHI
110010
India 
Phone  8854932130  
Fax    
Email  majoraditya@gmail.com  
 
Source of Monetary or Material Support  
Army Hospital Research and Referral Department of Anaesthesiology and Critical care,Delhi Cantt ,New Delhi 110010, India Delhi 
 
Primary Sponsor  
Name  Aditya Joshi 
Address  Department of Anaesthesiology and Critical Care Army Hospital Referral and Research Delhi Cantt New Delhi 110010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Aditya Joshi  Department of Anaesthesiology and Critical Care Army Hospital Referral and Research Delhi Cantt New Delhi 110010 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ColDrAditya Joshi  Army Hospital Research and Referral   Department of Anaesthesiology and critical care,Army Hospital Research and Referral,Delhi Cantt,New Delhi
New Delhi
DELHI 		 8854932130

majoraditya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group- Anatomical landmark guided group  Epidural analgesia given as per conventional anatomical landmark and loss of resistance technique then observed for first attempt success rate,block performance time,immediate complications like CSF leak ,bleeding within 15-20min 
Intervention  Preprocedural USG group epidural analgesia group  Preprocedural USG guided technique to use the assess the disc space then epidural given be given at that space with LOR technique then observed for first attempt success rate, block performance time , immediate complications like CSF leak and bleeding within 15-20min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  18 yrs to 80 yrsof age undergoing epidural block 
 
ExclusionCriteria 
Details  1) local infection at the site of puncture
2)Patients with coagulation disorder
3)Emergency Surgeries
4)Patients refusal to epidural block 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare of First attempt success rate of epidural block by using preprocedural ultrasound with anatomical landmark technique   While doing the procedure and 05 min 10min and 15 min after the procedure  
 
Secondary Outcome  
Outcome  TimePoints 
1)To assess the accuracy of epidural space identification using ultrasound
2)Toasses the reduction in any complication using preprocedural USG
3) Block performance time  		 While doing the procedure & 05min 10min & 15 min after the procedure



 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   21/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/07/2025 
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 blocks are frequently used in operative anesthesia and post-operative analgesia for management of post-operative pain . Conventional anatomical landmark and loss of resistance technique is gold standard but blind technique. they are surrogate marker but difficult to locate or palpate in patients with obesity, edema over back, spinal deformity. Using this technique a specific intervertebral level can be identified only in 30 percent

This study aims to observe and evaluate the impact of preprocedural USG on

success rate of epidural block placement. The focus of research will be on epidural space identification, reducing, number of attempts, and the incidence of complications, patient’s satisfaction block performance time. Findings of the research will be contributing insights toward improving the accuracy of epidural block placement. 

 

 

 
Close