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CTRI Number  CTRI/2026/04/107714 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On: 05/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ultrasound guided chest and abdominal nerve blocks effect in decreasing the need for strong pain medicines in patients undergoing heart surgery. 
Scientific Title of Study   “Efficacy of Ultrasound-Guided Pecto-Intercostal Fascial Block Combined with Rectus Sheath Block on Opioid Consumption in Patients Undergoing Cardiac Surgery: A Double-Blind Randomized Controlled 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 Sharan V 
Designation  DM resident 
Affiliation  Govind Ballabh Pant Institute of Post Graduate Medical Education and Research 
Address  Dept of anesthesiology and intensive care, sixth floor, academic block, GB pant hospital, new delhi, 110002

New Delhi
DELHI
110002
India 
Phone  9342368383  
Fax    
Email  sharanmourty96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachna Wadhwa 
Designation  Professor 
Affiliation  Govind Ballabh Pant Institute of Post Graduate Medical Education and Research 
Address  Dept of anesthesiology and intensive care, sixth floor, academic block, GB pant hospital, new delhi, 110002

New Delhi
DELHI
110002
India 
Phone  9891943326  
Fax    
Email  drrachnawadhwa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rachna Wadhwa 
Designation  Professor 
Affiliation  Govind Ballabh Pant Institute of Post Graduate Medical Education and Research 
Address  Dept of anesthesiology and intensive care, sixth floor, academic block, GB pant hospital, new delhi, 110002

New Delhi
DELHI
110002
India 
Phone  9891943326  
Fax    
Email  drrachnawadhwa@gmail.com  
 
Source of Monetary or Material Support  
Govind Ballabh Pant Institute of Post Graduate Medical Education And Research New Delhi 
 
Primary Sponsor  
Name  Govind Ballabh Pant Institute of Post Graduate Medical Education And Research 
Address  Govind Ballabh Pant Institute of Post Graduate Medical Education And Research New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharan V  Govind Ballabh Pant Institute of Post Graduate Medical Education and Research  Dept of anesthesiology and intensive care, sixth floor, academic block, GB pant hospital, new delhi, 110002
New Delhi
DELHI 		 9342368383

sharanmourty96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pecto Intercostal Fascial Block plus Rectus Sheath Block  Ultrasound guided Pecto Intercostal Fascial block using 20ml of 0.25%bupivacaine with 2.5mg dexamethasone on each side combined with bilateral rectus sheath block using 10 ml of 0.25% bupivacaine with 2.5mg dexamethasone on each side  
Comparator Agent  Standard Analgesia protocol  Patients will receive standard institutional analgesia protocol including intravenous opioids and non opioid analgesics without regional fascial plane blocks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 70 years planned for elective cardiac surgery on cardiopulmonary bypass(CPB) through median sternotomy . 
 
ExclusionCriteria 
Details  1.Hemodynamically unstable patients, Patients on intra arterial balloon pump(IABP) , preoperative inotropic support, Severe left ventricular dysfunction
2.Minimally invasive cardiac procedures
3.Patient requiring emergency surgery and redo cardiac surgery.
4.Patients with coexisting hepatic, renal or severe respiratory disease, diabetes milletus, morbid obesity , hematological disorders, psychiatric illness, cognitive impairement, alcohol and opioid abuse, pregnancy and chronic pain of non cardiac causes
5.Hypersensitivity reaction to the amide group of anesthetics and patients unwilling to be part of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Opioid consumption in the intraoperative period .  Intraoperative period.(from induction of anesthesia till shifting to ICU) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Postoperative pain scores by Numerical Rating Scale (NRS) at rest and during coughing at 1st,4th,8th,12th and 24th hours after extubation.
2.Total opioid requirement within 24 hours after extubation.
3.Time to extubation .
4.Hemodynamic parameters heart rate, systolic blood pressure, diastolic blood pressure, Mean arterial pressure and oxygen saturation in the perioperative period between groups.
 		 Perioperative period (from indcution till 24 hours post extubation) 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   04/05/2026 
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="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   This double-blind randomized controlled trial evaluates the effect of ultrasound-guided pecto-intercostal fascial block combined with rectus sheath block on perioperative opioid consumption in adult patients undergoing elective cardiac surgery via median sternotomy. Participants will receive either the regional blocks with standard analgesia or standard analgesia alone. Total opioid consumption within 24 hours postoperatively will be assessed.
There is limited evidence assessing the combined use of these two blocks as a pre-emptive analgesic in alleviating perioperative sternotomy pain, opioid consumption, role in facilitating early tracheal extubation and improving overall recovery outcomes. 
 
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