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CTRI Number  CTRI/2023/11/059968 [Registered on: 17/11/2023] Trial Registered Prospectively
Last Modified On: 08/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Analysing efficacy of two regional blocks in heart surgery 
Scientific Title of Study   Comparing erector spinae plane block with serratus anterior plane block for Coronary Bypass Graft Surgery 
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 Mandar Galande 
Designation  CONSULTANT 
Affiliation  ASHOKA MEDICOVER HOSPITAL 
Address  DEPARTMENT OF ANESTHESIA 7TH FLOOR, ASHOKA MEDICOVER HOSPITAL, INDIRANAGAR, WADALA ROAD NASHIK
ASHOKA MEDICOVER HOSPITALS, INDIRA NAGAR, WADALA ROAD, NASHIK 422009
Nashik
MAHARASHTRA
422009
India 
Phone  0253-6660076  
Fax    
Email  mandar.galande@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandar Galande 
Designation  CONSULTANT 
Affiliation  ASHOKA MEDICOVER HOSPITAL 
Address  DEPARTMENT OF ANESTHESIA 7TH FLOOR, ASHOKA MEDICOVER HOSPITAL, INDIRANAGAR, WADALA ROAD NASHIK
ASHOKA MEDICOVER HOSPITALS, INDIRA NAGAR, WADALA ROAD, NASHIK 422009
Nashik
MAHARASHTRA
422009
India 
Phone  0253-6660076  
Fax    
Email  mandar.galande@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mandar Galande 
Designation  CONSULTANT 
Affiliation  ASHOKA MEDICOVER HOSPITAL 
Address  DEPARTMENT OF ANESTHESIA 7TH FLOOR, ASHOKA MEDICOVER HOSPITAL, INDIRANAGAR, WADALA ROAD NASHIK
ASHOKA MEDICOVER HOSPITALS, INDIRA NAGAR, WADALA ROAD, NASHIK 422009
Nashik
MAHARASHTRA
422009
India 
Phone  0253-6660076  
Fax    
Email  mandar.galande@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANESTHESIA 7TH FLOOR, ASHOKA MEDICOVER HOSPITAL, INDIRANAGAR, WADALA ROAD NASHIK  
 
Primary Sponsor  
Name  MANDAR GALANDE 
Address  ASHOKA MEDICOVER HOSPITALS, INDIRA NAGAR, WADALA NAKA, 4220002 
Type of Sponsor  Other [investigator inititated] 
 
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 MANDAR GALANDE  ashoka medicover hospital  DEPARTMENT OF ANESTHESIA 7TH FLOOR, ASHOKA MEDICOVER HOSPITAL, INDIRANAGAR, WADALA ROAD NASHIK
Nashik
MAHARASHTRA 		 02536660076

mandar.galande@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT institute of medical sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Regional Block in Erector spinae plane (ESB)  After the induction of anesthesia for a patient undergoing surgery, ESB block given 20 ml of bupivacain 0.125% single shot is given on each side  
Intervention  Regional block in Serratus Anterior Plane   After the induction of anesthesia for a patient undergoing surgery, SAP block given in which 20 ml of bupivacain 0.125% single shot is given on each side  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1: Elective Cardiac Surgeries Undergoing General Anaesthesia.
2: Age Between 18 To 80
3: Asa Grade 1 To 3
 
 
ExclusionCriteria 
Details  1: Patient Refused To Give Consent For Study.
2: Patient Having Infections At Block Site.
3: Contraindication to Regional Anesthesia – preexisting coagulopathy, known local anesthetic sensitivity etc.
4: History Of Opiate Abuse
5: Pre- Existing Chronic Pain Or Cognitive Dysfunction.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
OPIOID REQUIREMENT  DURING OPERATION AND POST OP PERIOD 
 
Secondary Outcome  
Outcome  TimePoints 
POST-OP COMPLICATIONS AND QUALITY OF RECOVERY  DURING POST OPERATIVE PERIOD 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   20/11/2023 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  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 - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 30-03-2024 and end date provided 30-08-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   TITLE - Comparing erector spinae plane block with serratus anterior plane block for Coronary Bypass Graft Surgery. 
Background - Coronary artery bypass grafting surgery is done in those patients who are having multiple blockages in the coronary arteries or in those patients angioplasty is not possible. For CABG thoracotomy has to be performed which causes significant pain intra as well as post operatively. Erector spinae plane (ESP) block and serratus anterior plane (SAP) block promise effective thoracic analgesia compared with systemically administered opioids. Needs to be compared in terms of reduction in the opioids requirement during the surgery plus quality of recovery and overall morbidity after thoracic surgery.
Aim-  To compare the reduction of the opioids and to assess the quality of recovery and morbidity between ESB ( Erector spinae plane block) and SAP (Serratus anterior plane) block
primary Objectives - To assess the intra and post operative opioids requirement in erector spinae plane block versus serratus anterior plane block in patients undergoing CABG.
Secondary Objectives - To assess post-op complication using comprehensive complication index calculator and To assess quality of recovery as per QoR-15 Scale after CABG in ESP AND SAP block patients.
Selection criteria - Inclusion Criteria- 1. Elective Cardiac Surgeries Undergoing General Anaesthesia.2: Age Between 18 To 80 3:Asa Grade 1 To 3 Exclusion Criteria- 1: Patient Refused To Give Consent For Study. 2: Patient Having Infections At Block Site. 3: Contraindication to Regional Anesthesia – preexisting coagulopathy, known local anesthetic sensitivity etc. 4: History Of Opiate Abuse 5: Pre- Existing Chronic Pain Or Cognitive Dysfunction.
Materials Metods - •Study design - prospective randomized, observational study â€¢Duration -  4 to 8 months.
•Study groups – a) ESP – erector spinae plane block. b) SAP – serratus anterior plane block
•Levobupivacaine 0.25% 20ml on each side given in both the blocks. 
•Opioids requirement during the surgery and in the post op period will be noted as per haemodynamic parameters
•Quality of recovery will be assessed using the quality of recovery-15 (qor-15) scale at 24 h postoperatively. 
•Consent - Informed consent will be obtained prior to surgery.
• Group size - calculated using power analysis based on a previous study report.
sample size - In Dylan T. Finnerty et al in 2020.primary outcome was the QoR-15 score at 24 h postoperatively. The established minimum clinically important difference in QoR-15 is 8.0, and  SD of QoR-15 scores after major surgery is in the order of 16 (range of QoR score is 1–150).Therefore, assuming Type I error=0.05 and Type II error=0.2 (80% power to detect this difference), and using Power method  - Comparison of two means. Minimum estimated sample size was 82 (41 in each group), we will therefore include 90 patients (45 per group) to in accordance to the pre-specified selection criteria. 
 
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