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CTRI Number  CTRI/2024/06/068501 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
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   We are comparing the effect of Erector Spinae plane block versus Peritumoral Local Anaesthetic infiltration on Post operative immune response in patients undergoing surgery for Modified radical mastectomy  
Scientific Title of Study   Effect of Erector Spinae plane block versus Peritumoral Local Anaesthetic infiltration on Post operative immune response in patients undergoing surgery for breast cancer  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pathan Arief 
Designation  Post Graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no 413 ,Third floor,B L Taneja block ,Maulana Azad Medical College ,New delhi

Central
DELHI
110002
India 
Phone  9121933951  
Fax    
Email  arief16051997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhyanti kerai 
Designation  Associate professor  
Affiliation  Maulana Azad Medical College 
Address  Room no 413 ,Third floor,B L Taneja block ,Maulana Azad Medical College ,New delhi

Central
DELHI
110002
India 
Phone  9968527122  
Fax    
Email  arief16051997@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pathan Arief 
Designation  Post Graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no 413 ,Third floor,B L Taneja block ,Maulana Azad Medical College ,New delhi

Central
DELHI
110002
India 
Phone  9121933951  
Fax    
Email  arief16051997@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak hospital Bahadur Shah Zafar Marg New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College & associated Lok Nayak Hospital 
Address  Maulana Azad Medical College ,2 Bahadur shah zafar marg ,New delhi ,110002 
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 Pathan Arief  Lok Nayak Hospital,Maulana Azad medical college  Ot 1 ,First floor ,New operation theatre block ,Department of Anaesthesiology and Intensive care ,Loknayak Hospital
Central
DELHI 		 9121933951

arief16051997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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  Erector Spinae block  After induction of general anaesthesia ultrasound guided single shot Erector spinae block at T4 vertebral level will be performed using in-plane technique and 20 ml of 0.25% bupivacaine with dexmedetomidine 1 microgram per kg will be injected  
Comparator Agent  Local anaesthetic drug infiltration group  In this group after induction of general anaesthesia 10 ml of 2% lignocaine will be infiltrated around the tumor by the surgeons. The surgery will be started after waiting for 10-15 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1)Age18-65 years
2)ASA physical status I,II&III
3)unilateral breast cancer 
 
ExclusionCriteria 
Details  1. BMI more than 35kg/m2
2. any structural deformity of thoracic spine
3. known allergy to LA drugs
4. any infection at the site of block or infiltration
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Neutrophil to lymphocyte ratio in both the groups
2)Platelet to lymphocyte ratio in both the groups.  		 baseline and 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Mean difference in serum 1interleukin (IL)-6,IL-8 and vascular endothelial growth factor (VEGF) levels in both the groups at 24 hrs after surgery

 		 24 hours after surgery 
Total consumption of opioids  24 hours after surgery 
Quality of recovery-15  24 hours after surgery 
Time to return to intended oncological therapy  3 weeks or 4 weeks after surgery 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 
Date of First Enrollment (India)   15/06/2024 
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="0"
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   we are comparing the effect of ESP block with peritumoral local anaesthetic infiltration on inflammatory and immune response in patients undergoing surgery for breast cancer under General anaesthesia . The primary objective of the study is to compare the effect of ESP block and peritumoral local anaesthetic infiltration on post-operative markers of i nflammation ,immune suppression ,and angiogenesis in patients undergoing modified radical mastectomy , taking a sample size of 34 patients for the study. 
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