| 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
|
|
|
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
|
|
|
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. |