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CTRI Number  CTRI/2023/01/048917 [Registered on: 11/01/2023] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate analgesic efficacy of various regional anaesthesia techniques in breast cancer surgery  
Scientific Title of Study   Comparison of analgesic efficacy of fascial plane regional nerve blocks in non reconstructive breast surgery  
Trial Acronym  FPB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Kumar HR Health Care Global Enterprises Ltd 
Designation  Consultant  
Affiliation  Health Care Global Enterprises Ltd  
Address  Health Care Global Enterprises Ltd Department of anaesthesia Room no 8 Tower 3 III floor Kalingarao Road Sampangiram Nagar Bangalore 560027

Bangalore
KARNATAKA
560027
India 
Phone  9241271214  
Fax    
Email  drsunilkumar.r@hcgel.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunil Kumar HR 
Designation  Consultant  
Affiliation  Health Care Global Enterprises Ltd  
Address  Health Care Global Enterprises Ltd Department of anaesthesia Room no 8 Tower 3 III floor Kalingarao Road Sampangiram Nagar Bangalore 560027

Bangalore
KARNATAKA
560027
India 
Phone  9241271214  
Fax    
Email  drsunilkumar.r@hcgel.com  
 
Details of Contact Person
Public Query
 
Name  Sunil Kumar HR 
Designation  Consultant  
Affiliation  Health Care Global Enterprises Ltd  
Address  Health Care Global Enterprises Ltd Department of anaesthesia Room no 8 Tower 3 III floor Kalingarao Road Sampangiram Nagar Bangalore 560027

Bangalore
KARNATAKA
560027
India 
Phone  9241271214  
Fax    
Email  drsunilkumar.r@hcgel.com  
 
Source of Monetary or Material Support  
Health Care Global Enterprises Ltd  
 
Primary Sponsor  
Name  HCG Hospital 
Address  Health Care Global Enterprises Ltd Department of anaesthesia Room no 8 Tower 3 III floor Kalingarao Road Sampangiram Nagar Bangalore 560027 
Type of Sponsor  Research institution and hospital 
 
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 
Sunil Kumar HR  Health Care Global Enterprises Ltd   Health Care Global Enterprises Ltd Department of anaesthesia Room no 8 Tower 3 III floor Kalingarao Road Sampangiram Nagar Bangalore 560027
Bangalore
KARNATAKA 
9241271214

drsunilkumar.r@hcgel.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (2) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (3) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (4) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (5) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (6) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (7) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (8) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (9) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Block block  Erector Spinae Block block as an interventional fascial plain block will be performed during intraoperative period under general anaesthesia  
Comparator Agent  Fentanyl PCA as an active comparator   Fentanyl based PCA as a comparator agent will be initiated in the immediate post operative period beginning 0 hour after surgery  
Intervention  Pectoralis block  Pectoralis block as an intervention fascial plane block will be performed during intra operative period under general anaesthesia  
Intervention  Serratus Anterior Plane block   Serratus Anterior Plane block as an interventional fascial plane block will be performed during intraoperative period under general anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American Society of Aanaesthesiologist 1-3 
 
ExclusionCriteria 
Details  Non consenting
Known allergy to study drugs
Coagulation disorder
Uncontrolled comorbidities
Infection at surgical site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain score with numeric rating scale at different post operative time periods beginning 0 hour till 48 hours after surgery
 
Immediate post operative period at 0 hour 2nd hour 6th hour 12th hour 24th hour and 48 hours after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Total postoperative opioid consumed
Time to first rescue analgesia (hr)
Quality of recovery ( QoR 15)
Patient satisfaction scores. (PSS) 
Post operative pain score at different time periods till discharge 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/02/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients undergoing breast surgery experience marked acute pain postoperatively. The axillary component of the surgery is responsible of the majority of this pain.When the postoperative pain is not controlled well, this leads to both psychological and physiological negative consequences. While effective control of the acute pain suppresses the surgical stress response and decreases the opioids and general anesthetics needs, that leads to preservation of the immune response. In addition, regional anesthesia can reduce the stress response caused by surgical trauma.Opioid based analgesic techniques are associated with hyperalgesia, tolerance and predisposition to chronic pain. Fascial plane blocks are emerging as novel analgesia techniques for breast surgery with favorable pain scores, improved patient satisfaction and quality of recovery with additional advantage of opioid sparing being reported in literature. The practice of taking up breast surgeries as day care procedures favor administrating analgesic techniques with minimal residual or adverse effects Interfascial blocks score over regional anesthetic techniques such as PVB as they have no risk of sympathetic blockade, intrathecal or epidural spread.

 
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