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CTRI Number  CTRI/2025/01/079526 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Screening
Other (Specify) [OPTIC NERVE SHEATH DIAMETER, ICP CHANGES]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison Of High Volume And Low Volume Of Bupivacaine Drug On Optic Nerve Sheath Diameter By Using Ultrasound In Paediatric Patients Posted For Urogenital Surgeries  
Scientific Title of Study   A Randomised Controlled study- To Compare The Effect Of High Volume And Low Volume Of Bupivacaine Drug On Intra Cranial Pressure After Giving Caudal Block In Paediatric Population.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Ashneil Kohli 
Designation  Junior Resident 
Affiliation  Bharati Vidyapeeth Deemed To Be University 
Address  Department Of Anaesthesia Bharatiya Vidyapeeth medical College and Bharati hospital Dhankawadi Pune
Main OT 3rd Floor Bharati hospital Dhankawadi Pune
Pune
MAHARASHTRA
411043
India 
Phone  9906091730  
Fax    
Email  ashneil07171kohli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ashneil kohli  
Designation  Junior resident 
Affiliation  Bhartai Vidyapeeth Deemed To Be University Pune  
Address  Department Of Anaesthesia Bharatiya Vidyapeeth medical College and Bharati hospital Dhankawadi Pune
Main OT 3rd Floor Bharati hospital Dhankawadi Pune
Pune
MAHARASHTRA
411043
India 
Phone  9906091730  
Fax    
Email  ashneil07171kohli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ASHNEIL KOHLI 
Designation  JUNIOR RESIDENT 
Affiliation  BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY PUNE  
Address  DEPARTMENT OF ANAESTHESIA BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY PUNE MAHARASHTRA
B 804 SAMRAT SARTHAK APARTMENTS KATRAJ PUNE MAHARASHTRA
Pune
MAHARASHTRA
411043
India 
Phone  9906091730  
Fax    
Email  ashneil07171kohli@gmail.com  
 
Source of Monetary or Material Support  
Bharatiya Vidyapeeth Medical College and Bharati Hospital  
Ultrasound Machine 
 
Primary Sponsor  
Name  Dr Ashneil Kohli 
Address  Department Of Anaesthesia Bharatiya Vidyapeeth medical College and Bharati hospital Dhankawadi Pune  
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 
Dr Ashneil Kohli  Bharati Hospital   Main OT 3rd Floor Department Of Anaesthesia Third Floor Bharati hospital Dhankawadi Pune
Pune
MAHARASHTRA 
9906091730

ashneil0717kohli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PAEDIATRIC PATIENTS POSTED FOR LOWER UROLOGICAL SURGERIES. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 High Volume Bupivacaine (1ml/kg)  Checking Optic Nerve Sheath Diameter after Giving Caudal Block with HighVolume Bupivacaine (1ml /kg)In Paediatric Patients Undergoing Lower Urological Surgeries.  
Comparator Agent  Group 2 Low Volume ( 0.5 ml/kg)  Checking Optic Nerve Sheath Diameter after Giving Caudal Block with Low Volume Bupivacaine (0.5ml /kg)In Paediatric Patients Undergoing Lower Urological Surgeries.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  ASA I AND ASA II Patients scheduled for elective surgeries posted for urological and lower abdominal procedures suitable for caudal anaesthesia.
 
 
ExclusionCriteria 
Details  1.Parental / Guardian Refusal
2.Variation In Ultrasonographic Sacral Anatomy
3.Intracranial and Intraocular pathology
4.ACcute Neurological Disease
5.Bleeding diathesis
6.Open Fontanelles
7. SURGERIES IN PRONE/ LITHOTOMY/ LATERAL POSITION.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of two different volumes of the same drug given intra operatively after giving caudal block and measuring optic nerve sheath diameter by checking ultrasonographically.  Time intervals to be measured are as follows:
T0- Baseline - Before Giving Caudal Block
T1- Immediately After Giving Caudal Block
T2- 15 minutes After Giving Caudal Block
t3- 30 minutes After Giving Caudal Block 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic parameter throughout the entirety of operation   intra operatively before caudal (t0), immediately after caudal(t1), 15 mins after caudal(t2), 30 mins after caudal (t3)  
 
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   Phase 2 
Date of First Enrollment (India)   10/02/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  


Caudal block is commonly used technique in all types of surgery below the umbilicus  for postoperative analgesia in paediatric patients because of its safety and efficacy 

Unfused sacral hiatus allows for easy and safe access into the epidural space. However, caudal epidural Has its own advantages and disadvantages. The main disadvantages of block include urinary retention , excessive motor blockade especially if higher volume and concentration of local anaesthetic drug  has been used. 

 

Therefore, Different volumes according to surgical procedures has been advocated for caudal epidural analgesia..


The optic nerve sheath diameter (ONSD) is a measure of diameter of the protective sheath surrounding the optic nerve. Studies suggest that ultrasonographic measurements of optic nerve sheath diameter  correlate with signs of raised  intracranial pressure.  Hansen and Helmke showed that intrathecal infusion of lactated ringer’s solution leads to an increase in ONSD measured by ultrasonography.[2]


ONSD  is measured at three millimetres  behind the ocular globe , as the optic nerve is surrounded by fat and  the dural sheath is distensible within its fatty environment, particularly in case of raised  pressure in the cerebrospinal fluid.[3]



A study by Gautam et al. (2019) Conducted a study  wherein  use of caudal block and its effect on ONSD in  children of various age groups were recorded  and compared . He found that there was  high success rate with the technique especially in children younger than 5 years of age 


A study by lee et al. found that caudal block with a high volume of local anaesthetic can cause greater increase in Intra Cranial Pressure than caudal block with low volume of local anaesthetic 


There has been ultrasonographic evidence of bidirectional movement of CSF, coined  as the “CSF rebound mechanism”. When a considerable volume is shifted from spinal canal  to intracranial space, this volume should increase ICP to such a degree that it affects cerebral perfusion. As CSF is rebounded from intra cranial space to the spinal canal,  the cerebral perfusion should return towards baseline. Thus, helping  us in investigate  whether such changes in cerebral perfusion are associated with high volume caudal block. As ONSD is the direct reflection of intra cranial pressure, we decided  to use it as a marker.


As all these  studies suggest that the use of caudal block can lead to a increase in ONSD in children, but the effect may vary depending on the volume and concentration of local anaesthetic used and the age of child. Therefore, we decided to compare the effect of high volume and low volume Bupivacaine on intra cranial pressure after giving caudal block in paediatric  population.


 
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