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CTRI Number  CTRI/2025/09/094051 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 30/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Quality of recovery in breast conservation surgery. 
Scientific Title of Study   Comparison of quality of recovery, postoperative pain and inflammatory biomarkers amongst opioid free, opioid sparing versus opioid based general anesthesia in breast conservation surgery – A pilot randomized control study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Ramkiran 
Designation  Senior Consultant 
Affiliation  Sri Shankara Cancer hospital and research 
Address  Department of Anaesthesia and Critical Care
sri shankara cancer hospital 1st cross shankara mutt shankarapuram bangalore 560004
Bangalore
KARNATAKA
560078
India 
Phone  7263957169  
Fax    
Email  sramkiran44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  S Ramkiran 
Designation  Senior Consultant 
Affiliation  Sri Shankara Cancer hospital and research 
Address  Department of Anaesthesia and Critical Care
sri shankara cancer hospital 1st cross shankara mutt shankarapuram bangalore 560004

KARNATAKA
560078
India 
Phone  7263957169  
Fax    
Email  sramkiran44@gmail.com  
 
Details of Contact Person
Public Query
 
Name  S Ramkiran 
Designation  Senior Consultant 
Affiliation  Sri Shankara Cancer hospital and research 
Address  Department of Anaesthesia and Critical Care
sri shankara cancer hospital 1st cross shankara mutt shankarapuram bangalore 560004

KARNATAKA
560078
India 
Phone  7263957169  
Fax    
Email  sramkiran44@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Critical Care,Sri Shankara cancer hospital and research centre Bangalore 
 
Primary Sponsor  
Name  Self funded 
Address  Sri shankara cancer hospital and research centre 
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 
S Ramkiran  Sri Shankara cancer hospital and research centre   Department of Anaesthesia and Critical Care,1st cross shankara matt shankarapuram bangalore 560004
Bangalore
KARNATAKA 
7263957169

sramkiran44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (4) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Opioid Based group  Opioid based bolus and infusion included 
Intervention  Opioid Free group  IV Lignocaine 
Intervention  Opioid sparing group  Opioids, Paracetamol used 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients 18 to 75yrs presenting for breast conservation surgery
Consenting to be part of study
ASA classified
Upfront surgery or Prior NACT and RT
Associated sentinel LND
 
 
ExclusionCriteria 
Details  Non-consenting
Associated Axillary dissection
Mastectomy
Reconstructive breast procedures
Other comorbidities like psychiatric illness
hepatic
renal
cardiac dysrhythmia
pregnancy
chronic pain disorders
morbid obesity and allergy to Lignocaine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of Recovery QOR 15 score  Quality of Recovery QOR 15 score immediate postoperative period till 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Pain NRS
Inflammatory Biomarkers PCT CRP
Postoperative nausea vomiting
Patient satisfaction Likert scale
PPSP 3m
CPSP 6 m
Relapse within 1 yr
 
Till 1 year 
Pain NRS
Inflammatory Biomarkers PCT CRP
Postoperative nausea vomiting
Patient satisfaction Likert scale
PPSP 3m
CPSP 6 m
Relapse within 1 yr
 
Till 1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   29/09/2025 
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="6"
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  

Traditional pain management strategies often rely heavily on opiods which can be associated with adverse effects such as sedation, nausea and a risk of dependence. Off late, there is an increasing interest in opiod sparing multimodal analgesic techniques that incorporate regional anesthesia techniques and agents like Lignocaine to improve recovery and pain outcomes.

Traditional pain management strategies often rely heavily on opioids which can be associated with adverse effects such as sedation, nausea and a risk of dependence. Off late, there is an increasing interest in opioid sparing multimodal analgesic techniques that incorporate local anesthetics and agents like intravenous Lignocaine to improve pain outcomes and reduce the risk of developing chronic pain. Understanding the comparative benefits of these agents could guide clinical practice in selecting optimal peri-operative analgesic strategies, more importantly in preventing development of PPSP, CPSP. Opioids form an integral part of general anesthesia. In view of animal studies associating opioids with increased circulating tumor markers and tumor recurrence, more emphasis has been laid upon opioid sparing techniques.Intravenous lignocaine has been integrated as multimodal analgesia, along with regional anesthesia techniques and found to be beneficial in attenuating tumor markers and recurrence. The recovery and pain characteristics of patients vary among patients receiving opioid based general anesthesia with that of opioid sparing and opioid free techniques.

 
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