| CTRI Number |
CTRI/2026/03/105510 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A research to find effectiveness of deep parasternal intercostal block prior to sternotomy in off pump Coronary Artery Bypass graft surgery than conventional General anaesthesia . |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided Bilateral Deep parasternal intercostal block on attenuating stress response during median sternotomy in off pump Coronary Artery Bypass Graft Surgery - A prospective observational 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 |
Dr Pacha Utteja |
| Designation |
Postgraduate student |
| Affiliation |
Institute of Anaesthesiology |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College Madurai
Tamil Nadu
625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9346810946 |
| Fax |
|
| Email |
uttejapacha1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanmuga Sundaram M MD |
| Designation |
Professor Institute of Anaesthesiology Madurai Medical college |
| Affiliation |
Institute of Anaesthesiology |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College Madurai
Tamil Nadu
625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9842106367 |
| Fax |
|
| Email |
sundaramsvs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanmuga Sundaram M MD |
| Designation |
Professor Institute of Anaesthesiology Madurai Medical college |
| Affiliation |
Institute of Anaesthesiology |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College Madurai
Tamil Nadu
625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9842106367 |
| Fax |
|
| Email |
sundaramsvs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of anaesthesiology ,Government Rajaji Hospital and Madurai medical college
Madurai
Tamilnadu
625020 |
|
|
Primary Sponsor
|
| Name |
Dr Pacha Utteja |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College Madurai
Tamil Nadu
625020 |
| Type of Sponsor |
Other [self] |
|
|
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 Pacha Utteja |
Madurai medical college |
Jica OT complex,4th floor,Cardio Vascular Thoracic Surgery OT.
Madurai.
Tamil nadu.
Madurai
TAMIL NADU |
9346810946
uttejapacha1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Madurai Medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for elective off pump CABG surgery/ASA II,III and consent modified |
|
| ExclusionCriteria |
| Details |
Patients with Allergy to local anaesthetics,Coagulopathy or bleeding risks,severe pulmonary or hepatic dysfunction and patients without consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the stress attenuation during sternotomy and opioid requirement during surgery after giving parasternal intercostal block in CABG surgery during median sternotomy with hemodynamic parameters |
base line to 15 minutes after sternotomy intra operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess the use of rescue analgesia
post operative day of extubation |
with in 24hrs after surgery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Median sternotomy in cardiac surgery is associated with significant intrtaopoerative pain and hemodynamic stress. Opioids are commonly used for analgesia but may cause dose dependent adverse effects such as respiratory depression and delayed recovery.
The deep parasternal intercostal plane block is an ultrasound guided regional anaesthesia technique that provides analgesia to the anterior chest wall by blocking intercostal nerves.
This prospective randomized controlled trial evaluated the effect of bilateral DPIP block on intraoperative opioid consumption and hemodynamic response in patients undergoing elective cardiac surgery via sternotomy.
The study demonstrated that bilateral Deep parastyernal intercostal block significantly reduced intraoperative opioid requirement and improved hemodynamic stability at the time of sternotomy, without significant differences in postoperative pain scores or time to extubation.
Thus, Deep parasternal intercostal blockPIP is a safe and effective opioid-sparing technique that may be incorporated into multimodal analgesia for cardiac surgery.
|