| CTRI Number |
CTRI/2018/04/013175 [Registered on: 11/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound guided caudal epidural block in children |
|
Scientific Title of Study
|
“OPTIMAL ANGLE OF INSERTION OF NEEDLE FOR CAUDAL EPIDURAL BLOCK IN PAEDIATRIC PATIENTS- AN ULTRASOUND BASED OBSERVATIONAL STUDY†|
| Trial Acronym |
UGCEB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana K |
| Designation |
Junior resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology
VIMS,Ballari
Bellary KARNATAKA 583104 India |
| Phone |
7736186977 |
| Fax |
|
| Email |
anjanakariyath@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anjana K |
| Designation |
Junior resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology
VIMS,Ballari
Bellary KARNATAKA 583104 India |
| Phone |
7736186977 |
| Fax |
|
| Email |
anjanakariyath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Balabhaskar |
| Designation |
Professor |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Professor
Dept of Anaesthesiology
VIMS, Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9880012349 |
| Fax |
|
| Email |
sbalabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar Institute of Medical Sciences VIMS Ballari |
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences Ballari |
| Address |
Cantonment Ballari -583104 |
| 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 Anjana K |
Vijayanagar Institute of Medical Sciences |
Major OT complex,Dept of Anaesthesiology,Vijayanagar Institute of Medical Sciences,Ballari Bellary KARNATAKA |
7736186977
anjanakariyath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children posted for sub umbilical surgeries under caudal epidural anaesthesia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of either sex posted for elective subumbilical surgery under caudal
anaesthesia with general anaesthesia
2.ASA physical status I & II.
3.Age 2 to 10 years.
4.Body weight upto 20 kgs
|
|
| ExclusionCriteria |
| Details |
1.Refusal by parents for the procedure
2.Children with developmental anomalies
3.History of significant systemic disorders (cardiovascular, respiratory, central nervous system or renal system)
4.Preexisting musculoskeletal disorders
5.Allergy to the test drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the ideal angle of needle insertion for correct final placement during caudal epidural block in paediatric patients with ultrasound guidance. |
At the time of administration of caudal epidural block in paediatric patients with ultrasound guidance. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine depth of insertion of needle, frequency of hitting the bone, speed of procedure and distribution of drug in the space.
|
During the administration of caudal epidural block with USG guidance
|
|
|
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)
|
01/01/2018 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Caudal epidural anesthesia remains the most frequently performed regional anesthesia technique in pediatric age group for subumbilical surgeries, used to provide both intraoperative and post operative pain relief .Here, needle is placed through sacral hiatus to deliver medications into the epidural space. It was first introduced as landmark based blind technique. This block is deceptively easy to perform but rare and potentially serious complications can occur with a blind approach into the epidural space such as inadvertent intravenous injection, dural puncture and post dural puncture headache, intrathecal injection and total spinal anaesthesia, repeated attempts, failure to block, rectal puncture, etc.The evolution of US technology has provided a tool that can circumvent some of the inherent limitations of conventional epidural anaesthesia and analgesia. Successful caudal blockade depends upon correct placement of the needle in the caudal space. Using ultrasound guidance, needles can be inserted into the caudal epidural space under real time imaging or using a planned trajectory subsequent to a review of the relevant anatomy on prepuncture scan . This study aims at determining the optimal angle of needle insertion for a successful caudal block and to avoid puncture of the bone and other complications . This study aims at determining the anatomy of the caudal space . |