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CTRI Number  CTRI/2024/08/072469 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized Factorial Trial 
Public Title of Study   Two type of anesthesia techniques, high spinal anesthesia and erector spinae block are compared for recovery parameters in randomized controlled trial in paediatric cardiac surgery patients.  
Scientific Title of Study   Assessing the impact of fast track anesthesia strategies on recovery metrics in pediatric cardiac surgery : A Comparative study between high spinal anesthesia and erector spinae block in conjunction with general anesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  V M Vishwanath 
Designation  Senior resident 
Affiliation  PGIMER 
Address  Advanced cardiac centre, Cardiac anesthesia, department of anesthesia and critical care, sector 11, post graduate institute of medical education and research. 160011

Chandigarh
CHANDIGARH
160011
India 
Phone  8762145150  
Fax    
Email  vm.vishwanath123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr V M Vishwanath  
Designation  Senior resident 
Affiliation  PGIMER, Chandigarh 
Address  Advanced cardiac centre, Cardiac anesthesia, department of anesthesia and critical care, sector 11, post graduate institute of medical education and research. 160011

Chandigarh
CHANDIGARH
160011
India 
Phone  9968856948  
Fax    
Email  vm.vishwanath123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kulbhushan Saini 
Designation  Assistant Professor  
Affiliation  PGIMER, Chandigarh 
Address  Advanced cardiac centre, Cardiac anesthesia, department of anesthesia and critical care, sector 11, post graduate institute of medical education and research. 160011

Chandigarh
CHANDIGARH
160011
India 
Phone  9968856948  
Fax    
Email  kulbhushansaini007@gmail.com  
 
Source of Monetary or Material Support  
Division of cardiac anesthesia, Department of anaesthesia and intensive care, 4th floor, Adavanced cardiac center, Post graduate institute of medical research and education, sector 12, 160012 
 
Primary Sponsor  
Name  Post graduate institute of medical research and education 
Address  PGIMER, Sector 11, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V M VISHWANATH  PGIMER  4th floor, block A,b, CTVS PICU, DIVISION OF CARDIAC ANANETHESIA, DEPARTMENT OF CARDIAC ANAESTHESIA, SECTOR 12, CHANDIGARH
Chandigarh
CHANDIGARH 
8762145150

vm.vishwanath123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post graduate institute of medical education and research, chandigarh, institutuoinal ethics committee (intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Q208||Other congenital malformations ofcardiac chambers and connections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group: ESP BLOCK  : Erector spinae block group- Patients wiil be given USG guided erector spinae block at the T4-T5 level using Bupivacaine 0.25%, 0.4ml/kg with dexmedetomidine 0.5mcg/kg post induction.  
Intervention  High spinal group  High spinal anesthesia group - Patients will receive spinal anesthesia at the L3-L4 level using hyperbaric bupivacaine 0.5% (0.5mg/kg) and morphine (4mcg/kg). Duration of study will be one year. Each patient will be followed up till 24 hours. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1Acyanotic heart disease: ASD closure, VSD closure, without severe PAH with midline sternotomy.
2.ASA I –III.
 
 
ExclusionCriteria 
Details  1.Emergency cases.
2.Active respiratory infections.
3.Patients with contraindication to spinal anesthesia or erector spinae block.
4.History of allergies to local anesthetics.
5.Pre existing neurological or spinal disorders.
• Redo cardiac surgery.
• Severe Left ventricular dysfunction.
• Severe PAH.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of supportive mechanical ventilation after completion of surgery.  Primary outcome will be measured from completion of surgery, every hourly till the patients gets extubated. 
 
Secondary Outcome  
Outcome  TimePoints 
6To assess the post-operative fentanyl requirement.
•Quality of analgesia using MOPS score.
Time taken for mobilizing the patient.
Length of stay of the patient in the ICU.
Evaluate adverse effects: hypotension, bradycardia, respiratory depression, PONV.
 
24 HOURS 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/08/2024 
Date of Study Completion (India) 09/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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  

Pain after paediatric cardiac surgery is significant. Pain is associated with hemodynamic perturbations, tachyarrhythmias, increase in ventricular afterload, hypertension, pulmonary hypertensive crisis, intermittent right to left shunting, patient-ventilator dysynhroncy, impaired cough, prolonged duration of ventilation, complicate hemostasis,and hypoxia. Pain also has long term adverse effects like bowel failure and neurocognitive dysfunction1.

It is imperative to address pain and achieve good hemodynamic stability in order to wean the patients off the ventilator, mobilize the patients to prevent ventilator associated complications, and good wound healing1.

One of the approaches to addressing pain has been the use of NSAIDS and opioids. Opioids have been the crucial drugs in paediatric cardiac surgeries for intraoperative and post-operative analgesia. Use of high-dose opioids is associated with prolonged post operative recovery period and increased duration of mechanical ventilation, potential increase in ICU stay. Opioids are also associated with somnolence, delirium, disordered breathing, PONV, constipation and urinary retention1.

There has been an increasing interest in regional anesthesia techniques in cardiac surgery for analgesia and the advantages of hemodynamic stability and reducing opioid consumption.

Intrathecal morphine has been safely used for intraoperative and post-operative analgesia without significant adverse effects.2

Spinal anesthesia has been used in paediatric patients since 1899. Spinal anesthesia has been proposed to reduce post-operative apnea, post-operative respiratory dysfunction 3.

Intrathecal bupivacaine combined with intrathecal morphine with general anesthesia in adult patients has been found to reduce stress response and provide stable hemodynamics, although there can be a rare risk of epidural hematoma4.

There have been studies with intrathecal tetracaine with intrathecal morphine in paediatric cardiac surgical patients and found to have reduced stress responses, facilitating early extubation5.

ESP blocks have been described for pain management in thoracic surgeries and cardiac surgeries.It has advantages of being safer and simpler than thoracic epidural, paravertebral blocks6.

Local anesthesia drugs given in ESP block have limited duration of action, in order to prolong duration of analgesia Dexmedetomidine is added, which is selective alpha-2 agonist. Dexmedetomidine as an adjuvant provides effective and safe analgesia8.

The rationale for this study lies in the fact that there have been fewer studies of high spinal anesthesia using intrathecal hyperbaric bupivacaine with intrathecal morphine and bilateral ESP block in paediatric cardiac surgical patients for assessing fast tracking. Considering the large number of paediatric patients coming for cardiac surgery, with this knowledge gap we intend to compare impact of high spinal anesthesia and ESP block with general anesthesia for fast tracking in paediatric cardiac surgery.

 
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