| CTRI Number |
CTRI/2024/03/063523 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ultrasound-guided erector spinae plane block vs. midpoint transverse process to pleura block for pain relief during and after operation in paediatric heart surgery by open sternotomy approach: A randomized comparative study. |
|
Scientific Title of Study
|
Comparison of ultrasound-guided erector spinae plane block vs. midpoint transverse process to pleura block for perioperative analgesia in paediatric cardiac surgery by open sternotomy approach: A randomized comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJA AVINASH |
| Designation |
Senior Resident |
| Affiliation |
ABVIMS, Dr RML Hospital, New Delhi |
| Address |
Department of Cardiac Anaesthesia, ABVIMS, Dr RML Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9905012125 |
| Fax |
|
| Email |
raja.avinash007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasvinder Kaur Kohli |
| Designation |
Prof. & Head of Department |
| Affiliation |
ABVIMS, Dr RML Hospital, New Delhi |
| Address |
Department of Cardiac Anaesthesia, ABVIMS, Dr RML Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9810565356 |
| Fax |
|
| Email |
jasviderkohli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJA AVINASH |
| Designation |
Senior Resident |
| Affiliation |
ABVIMS, Dr RML Hospital, New Delhi |
| Address |
Department of Cardiac Anaesthesia, ABVIMS, Dr RML Hospital, New Delhi
DELHI
110001
India |
| Phone |
9905012125 |
| Fax |
|
| Email |
raja.avinash007@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS, Dr. RML Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Raja Avinash |
| Address |
Department of Cardiac Anaesthesia, ABVIMS, Dr RML Hospital, New Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 Raja Avinash |
ABVIMS, Dr RML Hospital |
Department of Cardiac Anesthesia
New Delhi
DELHI |
9905012125
raja.avinash007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/ABVIMS/RMLH |
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 |
Ultrasound-guided errector spinae plane block |
A bilateral ultrasound-guided block with inj. 0.25% Bupivacaine hydrochloride at a dose of 0.3 ml/kg is given. The skilled anesthesiologist will inject the liquid into B/L ESP using ultrasound. Data collection will be done by an anaesthetist blinded to the procedure. |
| Intervention |
ultrasound-guided midpoint transverse process to pleura block |
Bilateral ultrasound-guided block with inj. 0.25% Bupivacaine hydrochloride at a dose of 0.3 ml/kg is given. The skilled anaesthesiologist will inject the liquid into B/L MTP. Data collection will be done by an anaesthetist blinded to the procedure. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective cardiac surgical procedure via median sternotomy incision |
|
| ExclusionCriteria |
| Details |
1) Complex cardiac anomalies, including atrioventricular septal defect, coarctation of the aorta, severe stenosis or insufficiency of the semilunar valves and Tetralogy of Fallot
2) Local site infection
3) Systemic sepsis
4) History of allergy to local anaesthetic agent
5) Liver dysfunction
6) Redo surgery/Emergency surgery
7) Critically ill patient viz on mechanical ventilation, preoperative inotropic support
8) Thoracic vertebral abnormalities
9) Intraoperative and postoperative complications related to surgery or nature of the disease e.g., Intra-operative pulmonary hypertensive crisis, difficult CPB weaning, need for prolonged elective ventilation post-op.
10) Pre-existing coagulopathic disorder.
11) Parent refusal to consent and participation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation |
1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. Mean fentanyl consumption intraoperative and post-operative
2. Rescue analgesia requirement
3. Time to extubation
4. Length of ICU stay
|
upto 24 hr |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study is conducted to compare the a perioperative analgesic effect of two USG-guided intervantions named B/L MTP block and B/L ESP block. Each group has 35 patients, ranging in age from 1 to 10 years old, who are scheduled for cardiac surgery via an open sternotomy approach. We use 0.25% bupivacaine hydrochloride at 0.3 ml/kg in both groups. A skilled anesthesiologist will inject the liquid by using a 22-gauge, 5-cm echogenic needle at a level of 4-5 thoracic vertebrae. A comfort scale-based pain assessment will be performed at skin incision, sternotomy, weaning from bypass, 0 hr of shifting to ICU, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, and at extubation. total fentanyl consumption in 24 hours is also noted |