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CTRI Number  CTRI/2023/09/057509 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the ability of two types of ultrasound guided fascial plane block in obtunding post surgical pain in pediatric cardiac surgical patients. 
Scientific Title of Study   Comparison of ultrasound guided transverse thoracic muscle plane block and pecto-intercostal fascial plane block in reducing post operative pain in pediatric cardiac surgeries via median sternotomies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Jacob P 
Designation  senior registrar 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Cardiac anaesthesia Sree Chitra Tirunal Institute for Medical Science and technology Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9486809429  
Fax    
Email  jacobdivya24@sctimst.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Shrinivas V Gadhinglajkar 
Designation  Prof and HOD Department of Anaesthesia 
Affiliation  Sree Chitra Tirunal Institute for medical sciences and technology 
Address  Department of cardiac anesthesia SCTIMST Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9446304043  
Fax    
Email  shri@sctimst.ac.in  
 
Details of Contact Person
Public Query  
Name  Shrinivas V Gadhinglajkar 
Designation  Prof and HOD Department of Anaesthesia 
Affiliation  Sree Chitra Tirunal Institute for medical sciences and technology 
Address  Department of cardiac anaesthesia SCTIMST Thiruvanathapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9446304043  
Fax    
Email  shri@sctimst.ac.in  
 
Source of Monetary or Material Support  
Sree Chitra Tirunal Institute for Medical Sciences and Technology Jai Nagar Chalakkuzhi Thiruvananthapuram 
 
Primary Sponsor  
Name  Sree Chitra Tirunal Institute for Medical sciences and Technology 
Address  Medical College campus trivandrum Kerala 695011 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDivya Jacob P  Sree Chitra Tirunal Institute for Medical Sciences and Technology  3rd floor Dept of cardiac anaesthesia SCTIMST Medical college campus trivandrum
Thiruvananthapuram
KERALA 		 9486809429

jacobdivya24@sctimst.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SCTInstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, (2) ICD-10 Condition: Q219||Congenital malformation of cardiacseptum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ULTRASOUND GUIDED PECTO-INTERCOSTO FASCIAL PLANE BLOCK   USG guided pecto-intercosto-fascial plane block with 1ml/kg of 0.2% bupivaciane and 0.1mg/kg of dexamethasone given in 4divided injections on both sides of the sternum after giving general anesthesia and before the surgical incision 
Intervention  ULTRASOUND GUIDED TRANSVERSE THORACIC PLANE BLOCK  USG guided TTP block with 1ml/kg of 0.2% Bupivacaine and 0.1mg/kg of dexamethasone given in 4 divided injection on both sides of the sternum after giving general anesthesia and before the surgical incision 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1) Children with congenital heart disease with age more than 2yrs of age and less than 18yrs old 2) Children undergoing elective cardiac surgery through median sternotomy with cardiopulmonary bypass support 3) Children who are expected to be extubated with in 12hours after surgery 
 
ExclusionCriteria 
Details  ) Emergency surgeries 2) Chest wall abnormalities 3) Subjects with known contraindication or allergy to local anesthetics 4) Evidence of coagulopathy 5) Infection at the site of planned block 6) RACHS-1 score more than or equal to 3. 7) Patient shifted out to ICU with stented sternum or open chest. 8) Patient ventilated for more than 12hours after post op transfer to ICU 9) Severe PAH 10) Critically ill patient 11) Re-do surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
total opioid consumption in the first 24hours in both the groups   first 24hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Comparing FLACC/NRS score during the first 24hours after administration of block. 2. Time to rescue analgesia in both the groups receiving ultrasound guided blocks. 3. Comparing the intraoperative analgesic requirement. 4. To study intraoperative & post operative stress response as assessed by glucose and lactate level and total duration of ICU stay
5. To study the procedure related complications 		 in the first 6hr 12hour 18hour & 24hour 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/09/2023 
Date of Study Completion (India) 27/05/2024 
Date of First Enrollment (Global)  20/09/2023 
Date of Study Completion (Global) 27/05/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Pediatric cardiac surgery is associated with significant pain . Regional anesthesia helps in reducing intraoperative  and perioperative stress response and post operative  pain. This will reduce the total analgesia used and therefore help in early extubation .  We are trying to compare two types of parasternal blocks and its role in alleviating pain . Both the blocks are anterior parasternal block administered under ultrasound guidance . These blocks have been studied in adult patients and have been proven to have comparable results . These blocks are yet to be evaluated in pediatric population . In this study we propose  to assess the superiority of the 2 blocks.  The drugs used for the blocks are Bupivacaine and dexamethasone . The secondary objectives of this study include assessing pain in the post operative period , lactate and glucose levels. 
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