| CTRI Number |
CTRI/2025/03/082863 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative analgesia for paediatric patients |
|
Scientific Title of Study
|
A Comparative study between anatomical landmark technique and ultrasound guided caudal epidural block for post operative analgesia in children undergoing infra-umbilical surgeries |
| 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 Sunkesula Sonia Begum |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college, Kadapa |
| Address |
Department of Anesthesiology
Government medical college
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunkesula Sonia Begum |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college, Kadapa |
| Address |
Department of anesthesiology
Government medical college
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunkesula Sonia Begum |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college, Kadapa |
| Address |
Department of anesthesiology
Government medical college
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology
Government medical college
Kadapa |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Chiruvella |
| Address |
Head of the department
Department of anesthesiology
Government medical college
Kadapa
pin code: 516002
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 Sunkesula Sonia Begum |
Government general hospital |
Department of anesthesiology
Government general hospital
Kadapa
Cuddapah
ANDHRA PRADESH |
08897573489
sonia.sunkesula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anatomical landmark guided caudal epidural block |
Group B will receive anatomical landmark guided caudal epidural block by drug 0.25% bupivacaine 0.5ml/kg + Dexmedetomidine 1 mcg/kg single shot bolus only |
| Intervention |
Ultrasound guided caudal epidural block |
Group A will receive ultrasound guided caudal epidural block by drug 0.25% bupivacaine 0.5ml/kg + Dexmedetomidine 1 mcg/kg single shot bolus only |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children weighing less than 20 Kgs
Children belonging to ASA I and II categories |
|
| ExclusionCriteria |
| Details |
Children with suspected coagulopathy
Children with infection at the site of caudal block
Children with history of developmental delay and neurological diseases
Children with skeletal deformities in the caudal region |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Baseline, 2, 4, 6, 8, 12, 16,20, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total duration of analgesia
Number of punctures & time taken to perform to each block
Intra operative haemodynamic changes
Total dose of analgesia consumption
Adverse effects |
Baseline,2,4,6,8,12,16,20,24hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After a through preoperative evaluation, with children who comes under inclusion criteria will be premedicated. standard monitoring will be connected & monitored continuously throughout the surgery. after vascular access, patient administrated general anesthesia. post intubation, inhalational agent will be adjusted to maintain hemodynamic stability within 20% of baseline values, without other opioids or analgesia. following anaesthesia patients will be positioned & prepared for a caudal epidural block using ultrasound guided technique in group A patients, anatomical land mark technique in group B patients with local anesthetic administrated according to the armitage formula ( o.5ml/kg of 0.25% bupivacaine + dexmedetomidine 1mcg/kg). outcome variables will be measured for 24hours postoperatively. |