| CTRI Number |
CTRI/2025/04/085909 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of two different methods of analgesia for post-operative pain in children |
|
Scientific Title of Study
|
Comparison of caudal block versus splash block for post-operative analgesia in children
undergoing sub-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 MAANSI THAKUR |
| Designation |
Third year resident doctor |
| Affiliation |
B.J. medical college civil hospital |
| Address |
F3 First Floor Department of Anesthesia Civil hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09001107799 |
| Fax |
|
| Email |
maansithakur98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor and HOD |
| Affiliation |
B.J. medical college Civil hospital |
| Address |
F3 1st floor Department of anaesthesia Civil hospital
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor and HOD |
| Affiliation |
B.J. medical college Civil hospital |
| Address |
F3 1st floor Department of anaesthesia Civil hospital
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government of Gujarat Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India |
| 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 Maansi Thakur |
1200 bed hospital |
O3 wing pediatric operation theater 1200 bed Hospital
Civil hospital campus
Asarwa, Ahmedabad
Ahmadabad
GUJARAT |
09001107799
maansithakur98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B.J. medical college and civil hospital Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q89||Other congenital malformations, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal block and splash block |
Inj 0.2% ropivacaine 1ml/kg will be injected in Caudal block and Inj 0.2% ropivacaine 0.2ml/kg will be given in splash block
|
| Comparator Agent |
effect of Inj. Ropivacaine 0.2% by caudal block and splash block |
effect of 0.2% Inj. Ropivacaine will be compared with both blocks |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II, weight less than 25kg, elective hernia surgery |
|
| ExclusionCriteria |
| Details |
spinal deformity, local infection, coagulation disorder, CNS disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of analgesia |
post operative 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare pain severity by FLACC Score for 12 hours
2 To compare total analgesic consumption after surgery for 12 hours as rescue analgesia.
3. Any complication associated with the procedures like Nausea, vomiting, motor blockade, urinary retention
etc. |
post operative 12 hours |
|
|
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)
|
10/05/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Local anaesthetic drug Inj. Ropivacaine is used as it is a long acting regional anaesthetic and is well
tolerated for surgical anaesthesia as well as post operative pain. It has lower propensity for motor block
and reduced CNS toxicity and cardiotoxicity as it is less lipophilic than bupivacaine.6
This study is planned to compare analgesic effect of caudal block and splash block for inguinal
herniorrhaphy in pediatric patients. This study is based on the hypothesis that splash block can have a similar analgesic effect as that of caudal block in children undergoing inguinal hernia repair. |