| CTRI Number |
CTRI/2017/06/008910 [Registered on: 23/06/2017] Trial Registered Prospectively |
| Last Modified On: |
22/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which needle is better for caudal epidural block in children? |
|
Scientific Title of Study
|
“Comparison between Quincke’s type 22G (Gauge) spinal needle for Caudal Epidural block in Pediatric Regional Anaesthesia- A prospective pilot study.â€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrushali Ponde |
| Designation |
Consultant |
| Affiliation |
Surya Children Hospital |
| Address |
Surya Children Hospital
Anaesthesiology Department
S V road
Santacruz West
Mumbai 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrushali Ponde |
| Designation |
Consultant |
| Affiliation |
Surya Children Hospital |
| Address |
Surya Children Hospital
Anaesthesia Department
S V road
Santacruz West
Mumbai 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vrushali Ponde |
| Designation |
Consultant |
| Affiliation |
Surya Children Hospital |
| Address |
Surya Children Hospital
Anaesthesia Department
First floor Operation theater Complex
S V road
Santacruz West
Mumbai 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Surya Children Hospital
S V road
Santacruz West
Mumbai , 400050
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Surya Children Hospital |
| Address |
S v road, Santacruz west,Mumbai 400054 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vrushali Ponde |
Surya Children Hospital |
S V Road
Department of Anaesthesiology
Operation theater Complex, First Floor.
santacruz west
Mumbai 54
Mumbai
MAHARASHTRA |
9819886502
vrushaliponde@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Surya Hospital Academic Research Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children posted for elective surgeries under caudal block , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Posted for surgical procedure below umbilicus. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Appreciation of loss of resistance to the needle insertion
2 Needle Visualization under Ultrasound
3 Bloody tap
|
1. Appreciation of loss of resistance to the needle insertion
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bloody tap |
while the block is administered |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/07/2017 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Caudal epidural block is routinely used for pediatric patients. this technique is very popular because it provides very good pain relief.This procedure can be done with BD needles which are hollow and regular bevelled, and also by specialized styletted needles with a quinkie type of bevel. We hypothesized that the special needles may convey better tissue feels and loss of resistances during the trajectory as against the sharp BD needles.they would also be less traumatic and would be seen better under ultrasound. To test our hypothesis, we compared both the needles with respect to appreciation of grade of entry by feel as 1. not felt at all, 2. felt but not sure, 3. felt and very sure; visualization of the needle under ultrasound graded as 1. visualized very well, 2. not visualized well but drug spread seen and incidence of bloody tap. |