| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
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|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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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
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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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