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CTRI Number  CTRI/2024/07/069787 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 30/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Pain Relief in Minimally Invasive Heart Surgery Using Ultrasound-Guided Erector Spinae Plane Block 
Scientific Title of Study   A Prospective Study to Assess the Efficacy of USG Guided Erector Spinae Plane Block (ESPB) for Perioperative Analgesia in Patients Undergoing Minimally Invasive Cardiac Surgery (MICS) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dnyaneshwar Wanve 
Designation  Resident Doctor 
Affiliation  Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai 
Address  Department of anaesthesia, 4th floor,College building,Lokmanya Tilak medical college and municipal general hospital sion hospital Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7972179789  
Fax    
Email  dnyaneshwar111bw@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shakuntala Basantwani 
Designation  Additional professor  
Affiliation  Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai 
Address  Department of anaesthesia, 4th floor,College building,Lokmanya Tilak medical college and municipal general hospital sion hospital Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9819018461  
Fax    
Email  drbasantwani@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Shakuntala Basantwani 
Designation  Additional professor  
Affiliation  Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai 
Address  Department of anaesthesia, 4th floor,College building,Lokmanya Tilak medical college and municipal general hospital sion hospital Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9819018461  
Fax    
Email  drbasantwani@hotmail.com  
 
Source of Monetary or Material Support  
Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai, Maharashtra .Pin code 400022 
 
Primary Sponsor  
Name  Lokmanya tilakMunicipal Medical College and Hospital 
Address  Lokmanya Tilak Municipal Medical College and Hospital ,Sion West Mumbai 400022 
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 Dnyaneshwar wanve  Lokmanya tilak municipal medical college and general hospital sion mumbai  cardiovascular thoracic surgery operation theatre ,EMS Building ,2nd th floor lokmanya tilak minicipal medical college and Lokmanya tilak municipal general hospital sion Mumbai
Mumbai
MAHARASHTRA 
7972179789

dnyaneshwar111bw@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE, SION MUMBAI - 400022  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient undergoing MICS
Many types of heart procedure may be performed with MICS including - coronary artery bypass graft, aortic valve replacement, atrial septal defect, mital valve repair or replacement, tricuspid valve repair or replacement  
 
ExclusionCriteria 
Details  -Patients refusal to participate in study
-Allergy to Local anaesthetic agents
-History of substance abuse
-Emergency Surgery.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Intraoperative analgesics requirement

Duration of Erector spinae block

Post op Requirement of Rescue analgesics in 24 hrs
 
0 HRS 2HRS 6HRS 12HRS 24 HRS
 
 
Secondary Outcome  
Outcome  TimePoints 

1. Extubation Time
2. 1st Mobilisation time
 
0 HRS 2HRS 6HRS 12HRS 24 HRS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/07/2024 
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="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 prospective observational study aims to evaluate the efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) for perioperative analgesia in patients undergoing Minimally Invasive Cardiac Surgery (MICS) at Lokmanya Tilak Municipal General Hospital, Mumbai.

Objective: -The primary objective of this study is to assess the impact of ESPB on intraoperative analgesic requirements, duration of postoperative analgesia, and the need for rescue analgesics within the first 24 hours post-surgery. Secondary objectives include evaluating extubation time, time to first mobilization, and patient and surgeon satisfaction scores.

Methodology:- The study will include 30 adult patients scheduled for various MICS procedures, such as coronary artery bypass surgery, valve repairs, or septal defect corrections. Patients meeting inclusion criteria (age over 18 years, elective surgery, ability to provide informed consent) and not having any exclusion criteria (allergy to local anesthetics, history of substance abuse) will be enrolled after obtaining informed consent. Standard monitoring and anesthesia induction will be performed according to institutional protocols, with intravenous dexmedetomidine and atracurium used for maintenance. ESPB will be performed under ultrasound guidance at the T5 level using a high-frequency linear ultrasound transducer and a 20-gauge echogenic needle. A total of 20 ml of Ropivacaine 0.125% with Dexamethasone 8 mg will be administered in the ESPB procedure.

Outcome Measures:-Primary outcomes include intraoperative analgesic requirements, duration of analgesia post-administration, and the need for rescue analgesics within 24 hours. Secondary outcomes involve assessing extubation time, time to first mobilization, and patient and surgeon satisfaction scores. Pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, intraoperatively, and at 0, 2, 6, 12, and 24 hours postoperatively. Rescue analgesic administration will be recorded and analyzed for efficacy.

Statistical Analysis:-Descriptive statistics will summarize demographic and clinical characteristics, while inferential statistics (e.g., Z-test, Mc Nemar’s Chi-square test) will compare pre- and post-block outcomes. Statistical analysis will be conducted using STATA version 10.1, with a significance level set at p < 0.05.

Conclusion:- This study aims to contribute evidence on the efficacy of ESPB in enhancing perioperative pain management and recovery outcomes in patients undergoing MICS. The findings are expected to support the adoption of ESPB as an alternative or adjunct to systemic opioids in cardiac surgery, potentially leading to improved patient care and outcomes.

 
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