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CTRI Number  CTRI/2021/09/036782 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 30/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ESP Block for Breast Malignancy Surgery 
Scientific Title of Study   Comparison of 0.25%Bupivacaine vs 0.25%Bupivacaine with 0.5mcg/kg Dexmedetomidine administered by USG guided Erector Spinae Plane Block for postoperative analgesia after Breast Malignancy Surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshitha Puppala 
Designation  Junior Resident , BARC Hospital 
Affiliation  Junior Resident , BARC Hospital 
Address  Dept of Anaesthesiology BARC Hospital Anushakti Ng Mumbai
Dept of Anaesthesiology BARC Hospital Anushakti Ng Mumbai
Mumbai (Suburban)
MAHARASHTRA
400094
India 
Phone    
Fax    
Email  akshitha.puppala30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pritee H Bhirud 
Designation  Full Time Anaesthesiologist 
Affiliation  BARC Hospital 
Address  Dept of Anaesthesiology BARC Hospital Anushakti Ng Mumbai

Mumbai (Suburban)
MAHARASHTRA
400094
India 
Phone  9820669549  
Fax    
Email  priteehb@barc.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Pritee H Bhirud 
Designation  Full Time Anaesthesiologist 
Affiliation  BARC Hospital 
Address  Dept of Anaesthesiology BARC Hospital Anushakti Ng Mumbai

Mumbai (Suburban)
MAHARASHTRA
400094
India 
Phone  9820669549  
Fax    
Email  priteehb@barc.gov.in  
 
Source of Monetary or Material Support  
BARC Hospital 
 
Primary Sponsor  
Name  BARC Hospital 
Address  Anushakti Nagar Mumbai 400094 
Type of Sponsor  Other [Central Govt Hospital for DAE.] 
 
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 Pritee Bhirud  BARC HOSPITAL  MAIN OPERATION THEATRE, SECOND FLOOR, DEPT OF ANAESTHESIOLOGY, BARC Hospital Anushakti Nagar Mumbai 400094
Mumbai (Suburban)
MAHARASHTRA 		 9820669549

priteehb@barc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BARC Hospital Medical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.25% Bupivacaine with 0.5ug/kg Dexmedetomidine  USG Guided single shot ESPB block with 25 cc 0.25% Bupivacaine with 0.5ug/kg Dexmedetomidine followed by general anaesthesia for postoperative analgesia 
Comparator Agent  0.25% Bupivacaine   USG Guided single shot ESPB block with 25 cc 0.25% Bupivacaine followed by general anaesthesia for postoperative analgesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  i. Adult female patients (age: 18-65yrs).
ii. Patients with ASA physical status I and II.
iii. Patients undergoing breast malignancy surgery
 
 
ExclusionCriteria 
Details  i. Patients refusal.
ii. Patients with allergy to study drugs.
iii. Patients with heart block and betablockers.
iv. Heart rate <50bpm
v. Pregnancy.
vi. Patients with contraindications to peripheral nerve blocks like bleeding diathesis, localized skin infections and coagulopathy.

 
 
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 
Post operative pain  1,2,6,12 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
PONV  within 24hrs postop. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 24/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/08/2022 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Future publication 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Prospective Randomised  Comparative Double blind study evaluating analgesic efficacy of 0.25% Bupivacaine vs 0.25% Bupivacaine with 0.5ug/kg Dexmedetomidine via USG guided ESPB for post operative pain relief of Breast malignancy surgery.
 
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