| CTRI Number |
CTRI/2019/10/021613 [Registered on: 14/10/2019] Trial Registered Prospectively |
| Last Modified On: |
12/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ultrasound guided caudal block versus conventional block |
|
Scientific Title of Study
|
COMPARISON OF ULTRASOUND GUIDED CAUDAL BLOCK VERSUS ANATOMICAL LANDMARK BASED CAUDAL BLOCK IN PEDIATRIC SURGICAL CASES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nethra HN |
| Designation |
Assistant professor |
| Affiliation |
bangalore medical college and research institute |
| Address |
Department Of Anaesthesia
5th floor
BMCRISSH
Victoria hospital
KR road 02
Sf4,VVApartment
no.1 contour road
Padmanabhanagar
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
drnethrahn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nethra HN |
| Designation |
Assistant professor |
| Affiliation |
bangalore medical college and research institute |
| Address |
Department Of Anaesthesia
5th floor,
BMCRISSH
victoria hospitalcampus
KR road 02
Sf4 VV apartment
contour road
Padmanabhanagar
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
drnethrahn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nethra HN |
| Designation |
Assistant professor |
| Affiliation |
bangalore medical college and research institute |
| Address |
BMCRISSH
victoria hospital
KR road 02
Sf4 vv apartment
contour road
padmanabhanagar
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
drnethrahn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute Super Speciality Block
Victoria campus
K R Road
Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college and research institute super speciality hospital
kr road |
| 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 nethra |
BMCRISSH |
Department Of Anaesthesia
5th Floor ,OT
BMCRISSH BLOCK
Victoria Hospital Campus
k r road
560002
Bangalore
KARNATAKA |
08026981959
drnethrahn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI Ethics Committee,Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anatomical landmark guided caudal block |
anatomical landmarks are used in identifying sacral hiatus (bony landmarks) to locate sacral canal. The procedure is performed by feeling the landmarks by hand and introducing the block needle blindly |
| Intervention |
ultrasound guided caudal block |
ultrasound is used for identifying the sacral canal and procedure i.e block needle is introduced under ultrasound visualization. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
1. ASA physical state 1and 2
2. Age <10 years
3. Infraumbilical surgeries
|
|
| ExclusionCriteria |
| Details |
1. Lack of parental consent
2. Children with severe systemic disease
3. Coagulation disorders
4. Local infection at the site or allergy to local anaesthetic drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success rate of caudal block
|
30 min after start of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
complication
block performance time |
Complication -1 hour post operative
block performance time - intraoperatively
from time of needle insertion to completion of injection |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2019 |
| Date of Study Completion (India) |
29/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
approved for publication in
Indian Anaesthetists Forum
(Ahead of Print )
issue not alloted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Caudal block is a routine procedure performed for the management of peri-operative pain. conventional landmark guided block is performed routinely throughout the world. In our study we compared USG guided caudal block and anatomical landmark based block for the success rate , complications associated block techniques.Results - in ultrasound group success rate was 92.1% and bloody tap (3%) was the only complication noted. in anartomical landmark technique, success rate was 81.8% with complications of bloody tap (23.8%) ,subcutaneous swelling (15.2%) ,dural puncture (1.5%) and rectal perforation (1.5%).
Conclusion: Ultrasound guided caudal block improves success rate,reduces complications and ensures safety
|