| CTRI Number |
CTRI/2023/05/052230 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To test the effectiveness of two block in children for pain relief after heart surgeries. |
|
Scientific Title of Study
|
"To evaluate the effect of post-operative analgesia of erector spinae plane (ESP) block and pecto-intercostal fascial (PICF) block in pediatric cardiac surgeries" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnesh Kumar |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
gandhi medical college ,bhopal |
| Address |
Gandhi Medical College, Bhopal
Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7987662212 |
| Fax |
|
| Email |
swapnesh.sk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brajesh Kaushal |
| Designation |
Associate Professor in Department of Anaesthesiology |
| Affiliation |
Gandhi medical college , bhopal |
| Address |
Department of Anaesthesiology , Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425772151 |
| Fax |
|
| Email |
brajeshkaushal3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brajesh Kaushal |
| Designation |
Associate Professor in Department of Anaesthesiology |
| Affiliation |
Gandhi medical college , bhopal |
| Address |
Department of Anaesthesiology , Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425772151 |
| Fax |
|
| Email |
brajeshkaushal3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College, Bhopal |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical college |
| Address |
Gandhi Medical College,Bhopal (M.P) |
| 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 Swapnesh kumar |
Department of Anaesthesiology |
Gandhi Medical College Bhopal
Bhopal
MADHYA PRADESH |
7987662212
swapnesh.sk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q210||Ventricular septal defect, (2) ICD-10 Condition: Q211||Atrial septal defect, (3) ICD-10 Condition: Q213||Tetralogy of Fallot, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 2-17 years of either sex.
2) Pediatric patients undergoing congenital cardiac correction (ASD,VSD and TOF etc) surgery with median sternotomy.
3) Patients of ASA grade II and III. |
|
| ExclusionCriteria |
| Details |
1) Parents of patients refusal/ consent not given.
2) History of developmental delay or mental retardation.
3)Known allergy to local anaesthetic.
4) Clinically significant liver or renal disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of post-operative analgesia of erector spinal plane (ESP) block and pecto-intercostal fascial (PICF) block in pediatric cardiac surgeries using modified objective pain score(MOPS). |
When extubation criteria met, patient will be extubated and post-op pain assessment will be done at 0, 2, 4, 6, 8, 10 and 12 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
â— To observe intra operative and post operative opioid requirement and additional analgesic requirements.
â— To observe the duration of analgesia in both groups.
â— To observe adverse events, if any. |
At 0, 2, 4, 6, 8, 10 and 12 hrs. |
|
|
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)
|
28/05/2023 |
| 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="4"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative pain after cardiac surgery is difficult to assess in pediatric patients and pain management is also incomplete as sometimes verbal communication is not possible in pediatric patients. Inadequate pain control following sternotomy can result in adverse haemodynamic consequences and pulmonary complications, furthermore opioid analgesics may cause respiratory depression and apnoea in pediatric patients. With the introduction of newer fascial plane blocks such as erector spinae plane block(ESP) and pecto-intercostal fascial(PICF) block, the requirement of opioid analgesics can be minimized and complications of opioid analgesics can be avoided as these fascial plane blocks can produce excellent analgesia with the help of ultrasound guidance. The present study is conducted to evaluate the effect of post- operative analgesia of Ultrasound guided erector spinal plane (ESP) block and pecto-intercostal fascial (PICF) block in pediatric cardiac surgeries. |