| CTRI Number |
CTRI/2026/01/100325 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [Pain intervention] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of chest block in reducing blood pressure and heart rate perturbation to surgical incision in adult patients undergoing open heart surgeries |
|
Scientific Title of Study
|
The efficacy of ultrasound guided pecto intercostal fascial block in attenuating haemodynamic response to sternotomy in adult patients undergoing cardiac surgeries:A prospective randomized double blind controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chukkaluru Sumadhu |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr.C.Sumadhu
Assistant Professor,
Dept of Anaesthesiology,
SVIMS
Tirupati
Dr.C.Sumadhu
Assistant Professor,
Dept of Anaesthesiology,
SVIMS
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9177704349 |
| Fax |
|
| Email |
sumadhu13121991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Aloka Samantaray
Professor and Head of the Department
Dept of Anaesthesiology
SVIMS,Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490713247 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Aloka Samantaray
Professor and Head of the Department
Dept of Anaesthesiology
SVIMS,Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490713247 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Sri Venkateswara Institute of Medical Sciences
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 C Sumadhu |
Sri Venkateswara Institute of Medical Sciences,Tirupati |
Cardiothoracic Operation theatre,Sri Venkateswara Institute of Medical Sciences,SPMC(W),Tirupati
Chittoor
ANDHRA PRADESH |
9177704349
sumadhu13121991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I050||Rheumatic mitral stenosis, (2) ICD-10 Condition: I060||Rheumatic aortic stenosis, (3) ICD-10 Condition: I061||Rheumatic aortic insufficiency, (4) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (5) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pecto intercostal fascial block |
Pecto intercostal fascial block with bupivacaine and Dexamethasone in attenuating haemodynamic response to sternotomy |
| Comparator Agent |
Pecto intercostal fascial block |
Pecto intercostal fascial block with normal saline as control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective open heart surgery via median sternotomy |
|
| ExclusionCriteria |
| Details |
Inability to provide informed consent
2. Patients with urgent or emergency procedures
3. Allergy to amide type anaesthetics
4. Patients with preoperative inotropic or vasoactive drug support
5. Redo surgery
6. History of thoracotomy or mastectomy
7. Patients with a history of chronic pain or on chronic opioids or sedatives
8. Renal failure with estimated glomerular filtration rate<30mL/min (Cockcroft-Gault
formula)
9. chronic liver or kidney disease
10. Patients with coagulopathies
11. Pregnanant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
to compare the percentage change in heart rate,systolic blood
pressure,mean arterial presssure from the base line values at 1, 3, 5 minutes after
sternotomy. |
to compare the percentage change in heart rate,systolic blood
pressure,mean arterial presssure from the base line values at 1, 3, 5 minutes after
sternotomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Total intraoperative fentanyl requirement |
From induction of Anaesthesia to shifting out to recovery room |
| 2.Total postoperative fentanyl requirement in first 48 hours after surgery |
48 hours after shifting to recovery room |
3.Post operative pain magnitude measured by Numerical rating scale(NRS)(Annexure-1) at
30 minutes post extubation, then every 6 th hourly upto 24 hours post extubation |
30 min,6 hours,12 hours,18 hours,24 hours post extubation |
|
|
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)
|
15/01/2026 |
| 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="2"
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
|
Median sternotomy involves a surgical incision made onto the chest wall causing major haemodynamic changes mostly noted within 10 minutes after surgical incision.Traditionally intravenous opioids alone or in combination with other sedatives are used preemptively to attenuate this haemodynamic response and for postoperative pain management,but these are associated with potential side effects.In recent times,Parasternal blocks(Pectointercostal fascial block,transverse thoracic plane block)are commonly used for postoperative pain management following median sternotomy.There is limited data available on attenuation of haemodynamic response to median sternotomy by parasternal block in open heart surgery.Hence,the present study is designed to investigate the effect of Pecto intercostal fascial block on the attenuation of haemodynamic response to sternotomy in cardiac surgery involving median sternotomy |