| 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
|
|
|
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
|
|
|
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. |