| CTRI Number |
CTRI/2025/08/093427 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study involving participants undergoing breast cancer surgery , comparing Two anesthesia interventions( standard balanced anesthesia using opioid and opioid free anesthesia), to see which leads to better postoperative recovery as the main outcome |
|
Scientific Title of Study
|
Comparing Conventional Balanced Anesthesia And Opioid Free Anesthesia On Post Operative Recovery In Breast Cancer Surgery: A Randomized Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FARHANA VP |
| Designation |
DNB RESIDENT |
| Affiliation |
RAJAGIRI HOSPITAL, ALUVA |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
DIVISION 1
RAJAGIRI HOSPITAL
Ernakulam
KERALA
683112
India |
| Phone |
7356596352 |
| Fax |
|
| Email |
vpfarhana1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JOJI ANTONY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
RAJAGIRI HOSPITAL, ALUVA |
| Address |
HEAD OF THE DEPARTMENT
DEPARTMENT OF ANESTHESIOLOGY
RAJAGIRI HOSPITAL
Ernakulam
KERALA
683112
India |
| Phone |
9446464513 |
| Fax |
|
| Email |
Joji.Antony@rajagirihospital.com |
|
Details of Contact Person
Public Query
|
| Name |
FARHANA VP |
| Designation |
DNB RESIDENT |
| Affiliation |
RAJAGIRI HOSPITAL, ALUVA |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
DIVISION 1
RAJAGIRI HOSPITAL
Ernakulam
KERALA
683112
India |
| Phone |
7356596352 |
| Fax |
|
| Email |
vpfarhana1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| FarhanaVP |
RAJAGIRI HOSPITAL |
DEPARTMENT OF ANESTHESIOLOGY
DIVISION 1
Ernakulam
KERALA |
7356596352
vpfarhana1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajagiri Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine bolus and IV infusion will be using in the Opioid free group along with nerve block |
| Intervention |
Remifentanil |
Remifentanil bolus and IV infusion along with nerve block will be using in the conventional balanced anesthesia using opioid group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Age more than 18 years
American society of anesthesiolgy 1 to 3 classification
Breast Cancer surgeries - Breast conservation surgery and Modified radical mastectomy
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Known allergy to any of the study drugs
Refusal to participate or refusal to nerve block
Any contraindications to nerve block
Atrioventricular block
Heart rate less than 50 beats per minute
Patients with cognitive dysfunction or with psychiatric disorder
Patients with chronic pain or on opioid therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare quality of post operative recovery measuring by QoR 15 score between opioid free anesthesia and opioid based anesthesia in patients undergoing breast cancer surgeries |
24 HOURS AFTER SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare intra operative hemodynamic parameters, post operative nausea & vomiting, sedation level, length of stay in post anesthesia care unit & post operative analgesic requirement between opioid free anesthesia & opioid based anesthesia in patients undergoing breast cancer surgeries |
At baseline before induction of anesthesia
Intraoperatively every 15 min for first hour, every 30 minutes for remaining time
Post surgery 0 hour, 6 hour, 12 hour |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/09/2025 |
| 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
|
This study will be comparing post operative recovery between conventional balanced anesthesia and opioid free anesthesia in patients undergoing breast cancer surgeries in Rajagiri hospital aluva. Patients admitting for surgery in Rajagiri hospital only will be included in the study. |