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
|
|
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
|
|
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. |