| CTRI Number |
CTRI/2024/12/078086 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare if the epidural analgesic efficiency when placed directly in thoracic space v/s that placed in thoracic space thereaded from caudal space is same in children undergoing cardiac surgery who require epidural analgesia. |
|
Scientific Title of Study
|
Comparison of efficacy of epidural catheter inserted via direct thoracic space V/S caudal to thoracic space in children undergoing cardiac surgery. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avirneni Vaishnavi |
| Designation |
Resident |
| Affiliation |
Dr. D Y Patil Medical College Hospital and Research center |
| Address |
Department of Anaesthesiology, Dr. D Y Patil Medical College Hospital and Research Center, Pimpri, Pune
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9908223940 |
| Fax |
|
| Email |
vaishnavi.jun12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul K Sharma |
| Designation |
Cardiac Anaesthesia Faculty |
| Affiliation |
Dr. D Y Patil Medical College Hospital and Research center |
| Address |
Department of Anaesthesiology, Dr. D Y Patil Medical College Hospital and Research Center, Pimpri, Pune
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7251888789 |
| Fax |
|
| Email |
vipulsharmacta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avirneni Vaishnavi |
| Designation |
Resident |
| Affiliation |
Dr. D Y Patil Medical College Hospital and Research center |
| Address |
Department of Anaesthesiology, Dr. D Y Patil Medical College Hospital and Research Center, Pimpri, Pune
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9908223940 |
| Fax |
|
| Email |
vaishnavi.jun12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, Hitech OT 5th floor, DR D.Y. Patil Medical College Hospital and Recearch centre, Pimpri, Pune 411018 |
|
|
Primary Sponsor
|
| Name |
DR DY Patil Medical College Hospital And Research Centre |
| Address |
Sant Tukaram Nagar, Pimpri, Pune 411018 |
| Type of Sponsor |
Private 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 Avirneni Vaishnavi |
r. D.Y. Patil Medical College, Hospital and Research Centre |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri.
Pune
MAHARASHTRA |
9908223940
vaishnavi.jun12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr D Y Patil Medical College, Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal to thoracic epidural |
Epidural catheter reach thoracic level by placing the needle and achieving epidural space at caudal level and threading the catheter till desired level.Bupivacaine 0.125% infusion will be given. |
| Intervention |
Direct thoracic epidural |
Epidural catheter reach thoracic level by placing the needle and achieving epidural space at thoracic vertebral level. Bupivacaine 0.125% infusion will be given. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children less than 12 years of age scheduled for elective thoracic surgery under ASA 1 2 and 3 physical status. |
|
| ExclusionCriteria |
| Details |
Patients refusal
Patients with coagulopathy
Patients with vertebral deformities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safer placement of caudal epidural |
At the time of placement of epidural catheter. Considered Day 0. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare infection rate |
Till the time of removal of epidural - 72 hours. |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised study to compare the analgesic efficacy of epidural inserted directly to thoracic space v/s caudal to thoracic space in children undergoing cardiac surgeries. Complications and infection rates will be assessed |