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CTRI Number  CTRI/2025/04/084405 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of erector spinae block for post operative pain relief after cardiac surgeries  
Scientific Title of Study   Efficacy And Safety of bilateral erector spinae block versus conventional analgesic method for postoperative analgesia in cardiac surgery patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tejas sanjay patil 
Designation  Junior Resident  
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
Address  DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA 431003 INDIA

Aurangabad
MAHARASHTRA
431003
India 
Phone  7756980329  
Fax    
Email  22teju@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Nagesh Jambhure 
Designation  Associate Professor 
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
Address  DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA

Aurangabad
MAHARASHTRA
431003
India 
Phone  957971122  
Fax    
Email  drnagesh83@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nagesh Jambhure 
Designation  Associate Professor 
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
Address  DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA 431003 INDIA


MAHARASHTRA
431003
India 
Phone  957971122  
Fax    
Email  drnagesh83@gmail.com  
 
Source of Monetary or Material Support  
MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD 431003 I MAHARASHTRA INDIA 
 
Primary Sponsor  
Name  MGM Medical College and Hospital Aurangabad 
Address  Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad 
Type of Sponsor  Private 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 Tejas Patil  MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD  CARDIAC OT COMPLEX MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD
Aurangabad
MAHARASHTRA 		 7756980329

22teju@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS   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  BILATERAL ERECTOR SPINAE BLOCK FOR POSTOPERATIVE ANALGESIA IN CARDIAC SURGERY  In 35 patients of the study linear high frequency 12 MHz Probe M-Turbo will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T6 transverse process. Three muscles trapezius (uppermost) rhomboids major (middle) and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process. Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in plane approach a 100 mm stimuplex needle will be inserted in cephalad- caudal direction, until the tip is deep to erector spinae muscle. as evidenced by visible hydro dissection below the muscle plane, and on injection 1 ml of normal saline between the erector spinae muscle fascia and the transverse process. After confirming the location of the needle in this way, erector spinae block will be given by administering 15 ml of 0.25% ropivacaine + Inj. dexamethasone 4mg to the same plane after negative blood aspiration using 22G 100mm stimuplex needle. The same procedure will be performed on the opposite side 
Comparator Agent  CONVENTIONAL ANALGESIC METHODS FOR POSTOPERATIVE ANALGESIA IN CARDIAC SURGERY.  35 patients will be given 1 gm IV paracetamol, 100 mg IV tramadol Will be given postoperatively to cardiac surgery patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients posted for elective cardiac surgery using midline sternotomy incision under general anesthesia
2. Both males and females
3. Age group between 18-65 years
4. Patients weighing between 40 kg - 85 kg 
 
ExclusionCriteria 
Details  left main coronary artery disease
left ventricular ejection fraction less than 40 percent
anomalies of vertebral column and patients operated for thoracic spine surgeries
blood or CSF tap during the procedure
patient on anticoagulants bleeding diathesis
6. morbidly obese patients BMI more than 30 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Post operative VAS score
Total doses of rescue analgesics 		 Patients will be interrogated for pain by VAS visual analogue scale scoring system Pain will be classified into mild VAS 0to4 moderate 5to7 severe VAS more than 8 at rest and at deep breathing at 0 hr extubation and 3hr 6hr 12hr from extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia
Duration of cardiac surgery
Time to extubation
Total length of ICU stay
Incidence of local anaesthetic systemic toxicity
Complications Like pneumothorax & hematoma formation  		 Patients will be interrogated for pain by VAS visual analogue scale scoring system. Pain will be assessed at deep breathing at the time of extubation followed by 3hr 6hr 12hr from extubation. If VAS score more than 4 at rest or patients complains of pain IV fentanyl 1 mcg per kg will be given for rescue analgesia.  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [22teju@gmail.com].

  6. For how long will this data be available start date provided 06-10-2024 and end date provided 22-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The postoperative pain after cardiac surgeries is severe and causes significant patient discomfort, delayed recovery, and at times prolonged hospital stay. The multifactorial pain could be due to reasons like tissue damage, sternotomy, the presence of intercostal drains, rib fractures, and extensive retraction of the thoracic cage. The American Society of Anaesthesiologist task force on the management for acute postoperative pain, recommend the use of multimodal conventional techniques for pain management. These include regional analgesia, intravenous (IV), and oral analgesics. Opioids, paracetamol, and nonsteroidal anti-inflammatory drugs have been administered as parenteral analgesics. Opioids can cause nausea, vomiting, pruritus, and respiratory depression when they are used solely for analgesia.
Regional anaesthesia techniques like thoracic epidural analgesia and paravertebral blocks are excellent options but are usually not popular due to systemic heparinization during cardiovascular surgeries which may lead to hematoma formation. In the last few years, several chest wall blocks have been described and investigated for various thoracic surgeries including cardiac surgeries. Ultrasound guided (USG) erector spinae plane (ESP) block is recently introduced technique for regional analgesia in thoracic neuropathic pain, rib fractures, and breast surgeries.
We are performing this study to compare efficacy of convention al method of analgesia with ultrasound guided bilateral erector spinae block for postoperative pain management in cardiac surgical patients. 
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