| CTRI Number |
CTRI/2024/01/061849 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| 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
|
Regional blocks for pain management in paediatric cardiac surgery |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF ULTRASOUND GUIDED BILATERAL ERECTOR
SPINAE PLANE BLOCK AND TRANSVERSUS THORACIC MUSCLE PLANE BLOCK
FOR PAIN MANAGEMENT IN PAEDIATRIC CARDIAC SURGERIES VIA MEDIAN
STERNOTOMY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandhu S |
| Designation |
SR,DM Cardiothoracic and vascular anaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Senior Resident, DM Cardiothoracic and Vascular anesthesia (CTVA),Department of anesthesia,Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7200661884 |
| Fax |
|
| Email |
nandhusubramonian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneel P R |
| Designation |
Professor, Div of cardiothoracic and vascular anaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Department of anaesthesia, Sree Chitra Thirunal Institute for Medical Science and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9847280218 |
| Fax |
|
| Email |
suneel@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneel P R |
| Designation |
Professor, Div of cardiothoracic and vascular anaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Department of anaesthesia, Sree Chitra Thirunal Institute for Medical Science and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9847280218 |
| Fax |
|
| Email |
suneel@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute for Medical Science and Technology, Trivandrum, kerala |
|
|
Primary Sponsor
|
| Name |
Sree Chitra Tirunal Institute for Medical Science and Technology, Trivandrum |
| Address |
SCTIMST, Medicsl college campus, Trivandrum, Kerala-695011 |
| 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 Nandhu S |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
3rd floor, Dept. of caediac anaesthesia,SCTIMST,Medical college campus, Trivandrum
Thiruvananthapuram
KERALA |
7200661884
nandhusubramonian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sree Chitra Tirunal Institute for Medical Science and Technology |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ULTRASOUND
GUIDED BILATERAL ERECTOR SPINAE PLANE block |
USG guided ESP block with 1ml/kg levobupivacaine 0.2%+ 0.1mg/kg dexamethasone in 2 divided doses after giving general anaesthesia before surgical incision |
| Intervention |
ULTRASOUND GUIDED BILATERAL TRANSVERSUS THORACIC PLANE BLOCK |
USG guided TTP block with 1ml/kg levobupivacaine 0.2%+ 0.1mg/kg
dexamethasone in 4 divided doses after giving general anaesthesia before surgical incision |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children with congenital heart disease, between 2 to 18 years old with sinus
rhythm, undergoing elective congenital heart surgery requiring median
sternotomy and cardiopulmonary bypass |
|
| ExclusionCriteria |
| Details |
1)Emergency surgeries,
2)Chest wall and vertebral deformities
3)Subjects having known contraindication/allergy to local anaesthetics
4) Signs of coagulopathy
5) Infection at site of planned block
6) Severe pulmonary arterial hypertension (PAH)
|
|
|
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 |
To compare the postoperative pain in
paediatric cardiac surgeries done through a median sternotomy, in those
patients receiving either ultrasound guided Erector Spinae block or
ultrasound guided Tranversus thoracic plane block |
Upto 12 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative and postoperative analgesic requirement,duration of mechanical ventilation, postoperative lung complications and
duration of ICU stay and to study the procedure related
complications. |
Upto 12 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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 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
|
Postoperative pain is a side effect of a planned injury. As such, unlike
physiological pain, it does not play the role of warning and defense. Instead, it
leads to the development of a sequence of unfavourable pathophysiological
processes triggered by nociceptive stimulation.Pain and opioids used for its relief has been a attributable factor for prolonged ventilatory support and other side effects. Several anaesthetic blocks
have demonstrated to produce analgesia in humans undergoing median
sternotomy, including neuraxial techniques, transversus thoracis plane (TTP)
block, thoracic paravertebral block, erector spinae plane block, and parasternal
block. In this study we propose to study transversus thoracis plane (TTP) block and erector spinae plane block in providing pain relief in paediatric cardiac surgeery patients. Along with that other secondary objectives include to assess intraoperative and postoperative analgesic requirement,
duration of mechanical ventilation, postoperative lung complications, duration of ICU stay and procedure related
complications. |