| CTRI Number |
CTRI/2024/12/078696 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effects of two different pain management techniques in children undergoing open heart surgeries |
|
Scientific Title of Study
|
A comparative study on the analgesic efficacy of ultrasound-guided bilateral pecto-intercostal fascial block with an ultrasound guided caudal block in pediatric patients undergoing congenital cardiac surgeries- A randomised double blind 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 |
Joshna valaji |
| Designation |
Fellow resident |
| Affiliation |
Sri Padmavathi children heart centre, SVIMS university. |
| Address |
Department of pediatric cardiac anesthesia, Sri Padmavathi children heart centre, SVIMS UNIVERSITY, Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
08341859395 |
| Fax |
|
| Email |
v.joshna27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thanigai arasu |
| Designation |
Consultant cardiac anaesthesiologist |
| Affiliation |
Sri Padmavathi children heart centre, SVIMS university. |
| Address |
Department of pediatric cardiac anesthesia, Sri Padmavathi children heart centre, SVIMS UNIVERSITY, Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
09862520701 |
| Fax |
|
| Email |
thani9894252525@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joshna valaji |
| Designation |
Fellow resident |
| Affiliation |
Sri Padmavathi children heart centre, SVIMS university. |
| Address |
Department of pediatric cardiac anesthesia, Sri Padmavathi children heart centre, SVIMS UNIVERSITY, Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
08341859395 |
| Fax |
|
| Email |
v.joshna27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Padmavathi children heart centre TTD |
| Address |
Sri Padmavathi children heart centre, beside BIRDD hospital, SVIMS, Tirupati- 517507 |
| 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 Thanigai arasu |
Sri Padmavathi children heart centre |
Dr Joshna valaji , fellow resident in the division of paediatric cardiac anaesthesia, department of cardiac anaesthesia SVIMS university Tirupati
Chittoor
ANDHRA PRADESH |
09862520701
thani9894252525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/SVIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of analgesic efficacy of ultrasound guided bilateral PIFB with ultrasound guided caudal block in pediatric patients undergoing congenital cardiac surgeries. |
In Group I, under strict aseptic precautions after the correct identification of the Pecto Intercosto fascial plane saline hydro dissection will be done to confirm the plane followed by bupivacaine 2.5mg/kg (0.25%) and Fentanyl 1mcg/kg will be given under USG visualization. A total vol of 1 ml/kg was used which was distributed equally in both Pectoro Intercostal fascial planes (0.5ml/kg on each side)
In Group II, under strict aseptic precautions, the Sacral hiatus was identified using an ultrasound approach, Bupivacaine 2mg/kg (0.125%) and fentanyl 1 mcg/kg were injected into the caudal epidural space. A total volume of 1.5ml/kg was used. An incision will be made after 20 minutes of bolus administration of Local Anaesthetic in either group. After caudal block, a time gap of 1 hour is maintained for Heparin administration before cannulation.
|
| Intervention |
Pectointercostal fascial block and caudal block |
PIFB will be performed in the supine position in Group I and the Caudal block will be given in the Lateral recumbent position in Group II patients. In Group I, the In-plane approach using a high frequency 12 MHz linear ultrasound transducer (Fujifilm, SONOSITE EDGE II L25XP 6213 BOTHELL WASHINGTON, USA 98021.) will be used to perform the PIFB whereas in Group II caudal block is given by the in-plane approach under sterile aseptic precautions. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 6 months -7 years of age undergoing elective congenital cardiac surgery requiring median sternotomy and CPB will be included in the study. |
|
| ExclusionCriteria |
| Details |
a. Patients with RACHS (Risk Adjusted classification for Congenital Heart Surgery) score > 3
b. Emergency surgeries
c. Chest wall deformities
d. Anorectal malformations
e. Subjects allergic to local anaesthetics
f. Evidence of Coagulopathy
g. Patients on anticoagulants
h. Localized infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation |
Within 12hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pain scores in the postoperative period post extubation, duration of mechanical ventilation and the incidence of adverse effects |
Within 12hours |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
There are no studies done on the effectiveness of ultrasound-guided caudal block and comparing it with ultrasound-guided Pecto-intercosto fascial block in pediatric cardiac surgical patients. Hence, we propose to compare the analgesic efficacy of U/S guided PIFB and caudal epidural block in children undergoing open heart surgery through a median sternotomy approach. The primary outcome measure was to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation within 12 hour between U/S guided PIFB versus U/S guided caudal block. The secondary outcome measure will be to assess pain scores in the postoperative period post exubation within 12 hours, duration of mechanical ventilation and the incidence of adverse effects between U/S guided PIFB versus U/S guided caudal block.
|