| CTRI Number |
CTRI/2023/03/050335 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between opioid free anaesthesia and opioid anaesthesia in Breast cancer surgery |
|
Scientific Title of Study
|
Comparison between opioid free Anaesthesia and opioid Anaesthesia in Breast Cancer Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ISAAC LALBIEKTHANG JOUTE |
| Designation |
Junior Resident Anaesthesiology department |
| Affiliation |
Goa medical college and hospital |
| Address |
Goa medical college, bambolim,goa
North Goa
GOA
403202
India |
| Phone |
8472043522 |
| Fax |
|
| Email |
isaacljjoute@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Ann DSouza |
| Designation |
Professor and HOD Anaesthesiology Department |
| Affiliation |
Goa medical college and hospital |
| Address |
Department of Anaesthesiology, Goa Medical College, Bambolim
Goa
North Goa
403201
India
North Goa
GOA
403201
India |
| Phone |
9822159170 |
| Fax |
|
| Email |
shirley_dsouza05@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Ann DSouza |
| Designation |
Professor and HOD Anaesthesiology Department |
| Affiliation |
Goa medical college and hospital |
| Address |
Department of Anaesthesiology, Goa Medical College, Bambolim
Goa
North Goa
403201
India
North Goa
GOA
403201
India |
| Phone |
|
| Fax |
|
| Email |
shirley_dsouza05@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Goa medical College and hospital, Bambolim |
|
|
Primary Sponsor
|
| Name |
Goa medical college and hospital |
| Address |
Goa medical college and hospital, bambolim, goa |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Isaac Lalbiekthang Joute |
Goa medical college and hospital, Goa |
Lower operation theatre A and B,
Anaesthesiolgy department,
Goa medical College
Goa
North Goa
GOA |
8472043522
isaacljjoute@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOA MEDICAL COLLEGE BAMBOLIM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25% Bupivacaine and 1% Lignocaine |
USG guided PEC 1 and PEC 2 Block using solution of 20ml of 0.25% Bupivacaine and 20ml 1% Lignocaine with Adrenaline |
| Comparator Agent |
IV Fentanyl |
IV Fentanyl 2 ug/Kg bolus, followed by 2ug/kg/h as infusion, till the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI: 18-25
ASA Status: I, II
Surgery: Surgery for Cancer of Breast
Informed Consent |
|
| ExclusionCriteria |
| Details |
Pregnant& lactating women
History of allergy to Dexmedetomidine, Lignocaine,Bupivacaine
Patient on treatment with Beta blockers,
HR< 50/min
Epilepsy/ seizures
Obstructive sleep apnea |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Opioid Anaesthesia (OA) and Opioid free Anaesthesia (OFA) in reducing pain scores, postoperatively, in breast cancer surgery.
Pain will be assessed by visual analogue scale (VAS) score. |
VAS will be assessed at 0, 2, 4, 6, 12, 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare 1. Intraoperative hemodynamic parameters 2. Discharge time from Recovery Room 3. Duration of postoperative analgesia 4. Analgesia requirement in the postoperative period |
Intraoperative parameters
Stay in recovery room
Analgesia used post operative upto 24hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/03/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this trial is to compare the efficacy of opioid anaesthesia and opioid free anaesthesia in reducing pain scores, post operatively in breast cancer surgery |