| CTRI Number |
CTRI/2022/02/040291 [Registered on: 14/02/2022] Trial Registered Prospectively |
| Last Modified On: |
11/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of comparison between the conventional anatomy based caudal analgesia and ultrasound guided caudal analgesia in paediatric patients undergoing surgeries below the level of umbilicus |
|
Scientific Title of Study
|
A comparative study of ultrasound guided caudal block versus anatomical landmark
based caudal block in paediatric patients undergoing infra-umbilical surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Halder |
| Designation |
Postgraduate trainee, Anaesthesiology |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
IPGMER and SSKM Hospital
Department of Anaesthesiology
Room number 520
Main block
244 AJC Bose road
Kolkata 700020
West Bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9123036191 |
| Fax |
|
| Email |
sumanhalder8888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maitreyee Mukherjee |
| Designation |
Associate Professor |
| Affiliation |
IPGMER AND SSKM HOSPITAL, KOLKATA |
| Address |
IPGMER and SSKM Hospital
Department of Anaesthesiology
Room number 520
Main block
244 AJC Bose road
Kolkata 700020
West Bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maitreyee Mukherjee |
| Designation |
Associate Professor |
| Affiliation |
IPGMER AND SSKM HOSPITAL, KOLKATA |
| Address |
IPGMER and SSKM Hospital
Department of Anaesthesiology
Room number 520
Main block
244 AJC Bose road
Kolkata 700020
West Bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
IPGMER and SSKM Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology IPGMER and SSKM Hospital |
| Address |
IPGMER and SSKM Hospital
244 AJC Bose road
Kolkata 700020
West Bengal
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 Maitreyee Mukherjee |
IPGMER and SSKM Hospital |
Main OT complex
Room number 3 and 4
244 AJC Bose road
Kolkata 700020
West Bengal
India
Kolkata
WEST BENGAL |
9830415924
maitreyee1980.mm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT 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 |
Portable ultrasound machine |
Ultrasound imaging is a non-invasive technique by which we will compare the success rates of an effective caudal block given under USG guidance with that of anatomical landmark based block. Duration of intervention and monitoring will be during and immediately after the surgery |
| Intervention |
Realtime Ultrasound Imaging |
Caudal block will be given in the selected study population group under real-time ultrasound guidance by experienced anaesthesiologists. Duration of intervention and monitoring will be during and immediately after the surgery |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients belonging to either sex of age 1 month to less than 12 years.
b) Patients of ASA physical status I and II.
c) Patients scheduled to undergo various elective infra-umbilical surgeries |
|
| ExclusionCriteria |
| Details |
a) Patients aged less than 1 month
b) Refusal from parents to give consent for the procedure.
c) Patients with evidence of peripheral neuropathy, neurological deficit or
motor weakness.
d) Patients with significant cardiac, respiratory, hepatic or renal disorders
or any other uncontrolled systemic illness
e) Bleeding diatheses or history of using anticoagulation medications
f) History of pneumothorax
g) History of allergy to amide local anaesthetics.
h) Infection at the site of needle insertion.
i) History of seizures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) proper needle placement
2) no aspiration of blood
3) no aspiration of cerebrospinal fluid
4) no swelling in the sacral region |
Outcome will be monitored during performing the procedure. This is not a therapeutic study hence duration of the procedure (from placing the ultrasound probe to placement of the needle in the caudal epidural space) will be considered as time points. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An effective caudal analgesia without major hemodynamic alterations and avoiding inadvertent intravascular injection or dural puncture |
Intraoperative and 30 minutes after the surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
17/02/2022 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sumanhalder8888@gmail.com].
- For how long will this data be available start date provided 20-02-2023 and end date provided 20-02-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will help us compare the effectiveness and safety profile for caudal epidural blocks given by anatomical landmark based conventional method and the same given by USG guidance. With the help of real-time ultrasound imaging the procedure is expected to be given more safely avoiding inadvertent injection of local anaesthetics into intravascular and subarachnoid spaces |