| CTRI Number |
CTRI/2026/01/100565 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
How different amounts of numbing medicine used in caudal anaesthesia affect the eye nerve sheath size in children having lower abdominal surgery. |
|
Scientific Title of Study
|
Comparison of effect of different drug volumes of local anaesthetic for caudal analgesia on optic nerve sheath diameter in paediatric patients undergoing elective infra umbilical surgery. |
| 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 Swrang Daimari |
| Designation |
Post Graduate Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Main Operation Theatre Building, VMMC and Safdarjung Hospital,South West Delhi, New Delhi, India.
South West
DELHI
110029
India |
| Phone |
6900141297 |
| Fax |
|
| Email |
Swrangth8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P S Bhatia |
| Designation |
Consultant & Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Main Operation Theatre Building, VMMC and Safdarjung Hospital,South West Delhi, New Delhi, India.
South West
DELHI
110029
India |
| Phone |
7042142230 |
| Fax |
|
| Email |
psbhatia2@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swrang Daimari |
| Designation |
Post Graduate Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Main Operation Theatre Building, VMMC and Safdarjung Hospital,South West Delhi, New Delhi, India.
South West
DELHI
110029
India |
| Phone |
6900141297 |
| Fax |
|
| Email |
Swrangth8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital, New Delhi, India.
Pin code 110029 |
| Type of Sponsor |
Government 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 Swrang Daimari |
VMMC and Safdarjung Hospital |
Room no 06, Pre Anaesthetic Check up room, ground floor, Main OT complex, Department of Anaesthesiology
South West
DELHI |
6900141297
Swrangth8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Protocol Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K668||Other specified disorders of peritoneum, (2) ICD-10 Condition: N365||Urethral false passage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
This is an interventional study in which eligible paediatric patients undergoing elective infra-umbilical surgery will receive caudal analgesia with a local anaesthetic. |
This is an interventional study in which eligible paediatric patients undergoing elective infra-umbilical surgery will receive caudal analgesia with a local anaesthetic.
Group LV: Patients will receive caudal analgesia with 0.5 ml/kg of0.25% Ropivacaine.
Group HV : Patients will receive caudal analgesia with 1 ml/kg of the same local anaesthetic and concentration.
The primary outcome (optic nerve sheath diameter) will be measured and compared between the two groups at predefined time points. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
All patients in the age group of 6-60 months of either gender belonging to ASA I-II undergoing elective infra umbilical surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Spinal anomalies or infection at the sacral region.
2.Coagulopathy.
3.Ophthalmic disease.
4.Known case of increased ICP: Hydrocephalus, Space occupying lesions, infection etc.
5.Known allergic history to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare between 0.5ml/kg and 1.0ml/kg drug volumes of local anaesthetics for caudal analgesia on optic nerve sheath diameter in paediatric patients undergoing elective infra umbilical surgery. |
Measuring optic nerve sheath diameter before caudal block, and 1 minute, 10 minutes and 30 minutes after caudal block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the changes in vital parameters using 0.5ml/kg and 1.0ml/kg drug volumes of local anaesthetics for caudal analgesia. |
Measuring the changes in vital parameters before giving caudal analgesia, and 1 minute, 10 minutes and 30 minutes after caudal analgesia. |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/01/2026 |
| 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)
|
Not Yet Recruiting |
| 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 has
become one of the most popular regional anaesthesia techniques for paediatric
surgeries. It is administering of a local anaesthetic into the epidural space
via the sacral hiatus to achieve anaesthesia of sacral and coccygeal nerve
root. Depending on the site of surgery, different volumes are chosen for caudal
block procedure.
The optic nerve is a white
matter tract of the brain that transmits cerebral spinal fluid and fluctuates
in size based on changes in intracranial pressure. As optic nerve is capsulated
by the distensible subarachnoid space, any change of intracranial pressure
would theoretically reflect on this measurement. There is increasing evidence
that optic nerve sheath diameter via a well correlated parameter with
intracranial pressure and has high diagnostic precision for detecting altered
intracranial pressure in children. Trans-orbital sonography is one of the
non-invasive method to measure optic nerve sheath diameter.
In this study, we will
compare 0.5ml/kg and 1.0ml/kg drug volume of local anaesthetic for caudal
analgesia on optic nerve sheath diameter in paediatric patients from 6 months
to 60 months belonging to ASA I-II undergoing elective infra-umbilical.
The methodology and
procedure of the study will be explained to the patients’ parents and informed
written consent will be taken from parents. A computer generated random number
table will be used allocate patients in 2 groups (Group low volume and Group
high volume).
Patients will be taken to
the OT, monitors will be attached and baseline vitals noted. After
preoxygenation with 100% oxygen, induction with fentanyl, propofol and muscle
relaxant and intubating with LMA will be done.
Based on allocated drug
volume 0.5ml/kg or 1.0ml/kg drug volume will be taken for caudal block. A
baseline optic nerve sheath diameter will be measured before giving caudal
block and measured again after 1 minute, 10 minutes and 30 minutes after giving
caudal block. BP, HR, end tidal carbon dioxide, end tidal sevoflurane, oxygen
saturation will also be noted simultaneously.
|