| CTRI Number |
CTRI/2021/06/034021 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| 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
|
A clinical trial to study the effect of changes in the strength of pulse to predict the onset of caudal block which is a method of giving pain relief in children |
|
Scientific Title of Study
|
A Randomised controlled single blinded clinical trial to evaluate the effectiveness of Perfusion Index as a predictor of successful caudal block in children under 5 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DESIKA PRIYADARSHINI |
| Designation |
MD ANAESTHESIOLOGY |
| Affiliation |
MADRAS MEDICAL COLLEGE |
| Address |
INSTITUTE OF ANAESTHESIOLOGY AND CRITICAL CARE
MADRAS MEDICAL COLLEGE
CHENNAI
Chennai
TAMIL NADU
600003
India |
| Phone |
8072761854 |
| Fax |
|
| Email |
dr.desithaniga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N KRISHNAN |
| Designation |
MD ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN |
| Address |
DEPARTMENT OF PEDIATRIC ANAESTHESIOLOGY
INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN
CHENNAI EGMORE
Chennai
TAMIL NADU
600008
India |
| Phone |
9444451194 |
| Fax |
|
| Email |
krishpaedanaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N KRISHNAN |
| Designation |
MD ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN |
| Address |
DEPARTMENT OF PEDIATRIC ANAESTHESIOLOGY
INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN
CHENNAI EGMORE
Chennai
TAMIL NADU
600008
India |
| Phone |
9444451194 |
| Fax |
|
| Email |
krishpaedanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| MADRAS MEDICAL COLLEGE, CHENNAI |
|
|
Primary Sponsor
|
| Name |
Institute of Anaesthesiology and Critical care |
| Address |
Institute of Anaesthesiology and Critical care
Madras medical college
Chennai |
| 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 |
| N KRISHNAN |
Institute of Child health and hospital for children |
DEPARTMENT OF PEDIATRIC ANAESTHESIOLOGY
INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN
CHENNAI EGMORE
Chennai
TAMIL NADU |
9444451194
krishpaedanaes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MADRAS MEDICAL COLLEGE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N430||Encysted hydrocele, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: N471||Phimosis, (5) ICD-10 Condition: N472||Paraphimosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal block |
Caudal block will be given and perfusion index monitored at T0min,T3min,T5,T10,T15,T20,T30 and hourly till 6 hours |
| Comparator Agent |
Nerve blocks for pain relief |
Nerve blocks will be given and perfusion index monitored at T0min,T3min,T5min,T10,T15, T20, T30 and hourly till 6 hours in the recovery room |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children under 5 years
Elective infraumbilical surgeries
ASA PS I |
|
| ExclusionCriteria |
| Details |
Parents refusal
Allergic to drug
Severe cardiovascular, respiratory,renal, neurological, hepatic disease
Local infection
Bleeding diathesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To monitor perfusion index after caudal block at regular time intervals at T0,T3,T5,T10,T15,T20,T30 |
Baseline,3min,5min,10min,15min,20min,30min and hourly till 6 hours in the recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Hemodynamic parameters |
Perioperative period |
|
|
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)
|
10/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Planning to start study after getting CTRI permission |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised controlled single blinded clinical trial to evaluate the effectiveness of Perfusion Index as a predictor of successful caudal block in children under 5 years.Perfusion index is measured at baseline and after caudal block in one group and without caudal block in another group.More than 100% Increase in perfusion index will be considered as onset of successful caudal block |