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CTRI Number  CTRI/2018/04/013175 [Registered on: 11/04/2018] Trial Registered Retrospectively
Last Modified On: 04/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   Ultrasound guided caudal epidural block in children  
Scientific Title of Study   “OPTIMAL ANGLE OF INSERTION OF NEEDLE FOR CAUDAL EPIDURAL BLOCK IN PAEDIATRIC PATIENTS- AN ULTRASOUND BASED OBSERVATIONAL STUDY” 
Trial Acronym  UGCEB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjana K 
Designation  Junior resident 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Dept of Anaesthesiology VIMS,Ballari

Bellary
KARNATAKA
583104
India 
Phone  7736186977  
Fax    
Email  anjanakariyath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjana K 
Designation  Junior resident 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Dept of Anaesthesiology VIMS,Ballari

Bellary
KARNATAKA
583104
India 
Phone  7736186977  
Fax    
Email  anjanakariyath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Balabhaskar 
Designation  Professor 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Professor Dept of Anaesthesiology VIMS, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9880012349  
Fax    
Email  sbalabhaskar@gmail.com  
 
Source of Monetary or Material Support  
Vijayanagar Institute of Medical Sciences VIMS Ballari 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences Ballari 
Address  Cantonment Ballari -583104 
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 
Dr Anjana K  Vijayanagar Institute of Medical Sciences  Major OT complex,Dept of Anaesthesiology,Vijayanagar Institute of Medical Sciences,Ballari
Bellary
KARNATAKA 
7736186977

anjanakariyath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children posted for sub umbilical surgeries under caudal epidural anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Children of either sex posted for elective subumbilical surgery under caudal
anaesthesia with general anaesthesia
2.ASA physical status I & II.
3.Age 2 to 10 years.
4.Body weight upto 20 kgs

 
 
ExclusionCriteria 
Details  1.Refusal by parents for the procedure
2.Children with developmental anomalies
3.History of significant systemic disorders (cardiovascular, respiratory, central nervous system or renal system)
4.Preexisting musculoskeletal disorders
5.Allergy to the test drugs.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the ideal angle of needle insertion for correct final placement during caudal epidural block in paediatric patients with ultrasound guidance.  At the time of administration of caudal epidural block in paediatric patients with ultrasound guidance. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine depth of insertion of needle, frequency of hitting the bone, speed of procedure and distribution of drug in the space.

 
During the administration of caudal epidural block with USG guidance

 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/01/2018 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Caudal epidural anesthesia remains the most frequently performed regional anesthesia technique in pediatric age group for subumbilical surgeries, used to provide both intraoperative and post operative pain relief .Here, needle is placed through sacral hiatus to deliver medications into the epidural space. It was first introduced as landmark based blind technique. This block is deceptively easy to perform but rare and potentially serious complications can occur with a blind approach into the epidural space such as inadvertent intravenous injection, dural puncture and post dural puncture headache, intrathecal injection and total spinal anaesthesia, repeated attempts, failure to block, rectal puncture, etc.The evolution of US technology has provided a tool that can circumvent some of the inherent limitations of conventional epidural anaesthesia and analgesia. Successful caudal blockade depends upon correct placement of the needle in the caudal space.  Using ultrasound guidance, needles can be inserted into the caudal epidural space under real time imaging or using a planned trajectory subsequent to a review of the relevant anatomy on prepuncture scan . This study aims at determining the optimal angle of needle insertion for a successful caudal block and to avoid puncture of the bone and other complications . This study aims at determining the anatomy of the caudal space .

 

 
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