FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017421 [Registered on: 04/02/2019] Trial Registered Prospectively
Last Modified On: 01/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A COMPARITIVE TRIAL OF ULTRASOUND GUIDED VERSUS CONVENTIONAL INJECTION FOR CAUDAL BLOCK IN CHILDREN UNDERGOING INFRA UMBILICAL SURGERIES 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL COMPARING ULTRASOUND GUIDED VERSUS CONVENTIONAL INJECTION FOR CAUDAL BLOCK IN CHILDREN UNDERGOING INFRA UMBILICAL SURGERIES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Navya Sri Lalitha Kollipara 
Designation  Post Graduate 
Affiliation  SRI RAMACHANDRA UNIVERSITY 
Address  Dr. Navya Sri Lalitha K. Department of Anaesthesiology Sri Ramachandra University, PORUR,CHENNAI

Chennai
TAMIL NADU
600116
India 
Phone  8106157890  
Fax    
Email  navya.kollipara@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  VRAJESH KUMAR KODALI 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI RAMACHANDRA UNIVERSITY 
Address  DEPARTMENT OF ANAESTHESIA, SRI RAMACHANDRA UNIVERSITY, PORUR, CHENNAI

Thiruvallur
TAMIL NADU
600116
India 
Phone  9444230150  
Fax    
Email  vrajesh.kodali@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  VRAJESH KUMAR KODALI 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Sri Ramachandra University, Porur, Chennai. 
Address  DEPARTMENT OF ANAESTHESIA, SRI RAMACHANDRA UNIVERSITY, PORUR, CHENNAI

Thiruvallur
TAMIL NADU
600116
India 
Phone  9444230150  
Fax    
Email  vrajesh.kodali@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra University 
 
Primary Sponsor  
Name  Sri Ramachandra University 
Address  Department of Anaesthesiology Critical Care and Pain Medicine Sri Ramachandra University, Ramachandra Nagar, Porur  
Type of Sponsor  Research institution and hospital 
 
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 
Navya Sri Lalitha  Sri Ramachandra University  Department of Anaesthesiology, Critical Care and Pain Medicine Sri Ramachandra University, Ramachandra Nagar, 600116
Chennai
TAMIL NADU 
8106157890

navya.kollipara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee, Sri Ramachandra University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional caudal block  routine conventional caudal block will be given by palpating the sacral hiatus 
Intervention  Ultrasound Guided Caudal Block  ultrasound will be used to adminster the caudal block 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  patients undergoing elective infra-umbilical surgeries with ASA physical status I and II 
 
ExclusionCriteria 
Details  ASA physical status III and above
Emergency surgeries
Infection at the site of caudal injection
Sacral bone abnormalities
Bleeding disorders
Allergy to local anaesthetics
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
First puncture success rate   Reaching sacral canal or sacral hiatus with a single needle orientation on 1st puncture without withdrawal from skin. 
 
Secondary Outcome  
Outcome  TimePoints 
Block performing time  Time from needle insertion to termination of local anaesthetic administration  
Successful block  Defined as absence of limb movements and no increase in heart rate or mean arterial pressure above 15% from baseline on skin incision 
Complications(if any)  Vascular puncture, subcutaneous tissue bulging,Dural puncture and local anaesthetic toxicity 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/02/2019 
Date of Study Completion (India) 28/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
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  

·       Regional anaesthetic techniques are known to  reduce the post-operative morbidity, provide early mobilisation and reduce opioid requirements. Caudal epidural block is a widely used regional anaesthetic technique especially in paediatric surgery to provide intraoperative and post-operative analgesia in surgeries below umbilical level(T10-S5 dermatomes). Conventional single shot caudal block technique involves the risk of dural or vascular puncture, intra osseous injection, soft tissue bulging and systemic toxicity. Many anatomic variations have been reported for sacral hiatus and sacral cornua. Therefore, success rate of classic caudal epidural technique has been reported to be about 75%. Ultrasonography is helpful for visualisation of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and distribution of local anaesthetic agent within the epidural space therefore significantly increases the block success rate. Indian data on caudal epidural block has been scarce and world over, the number of studies on ultrasound guided caudal epidural block is minimal. Hence we wish to conduct a randomised control study comparing ultrasound guided caudal block versus conventional caudal block in children undergoing elective infraumbilical surgeries. The primary outcome would be the first puncture success rate comparing both the arms. Other outcomes such as  block performing time, success of the block and complications would also be assessed. The study would be conducted over a period of 6 months in the department of anaesthesia at a tertiary care centre hospital in southern India. 

 
Close