| CTRI Number |
CTRI/2026/03/106064 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two ruotine techniques of anaesthesia to provide better recovery in breast cancer surgeries. |
|
Scientific Title of Study
|
Opioid free anaesthesia with Pecs and Pecto-Intercostal fascial
plane blocks versus opioid based general anaesthesia in breast cancer surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul C Thankachen |
| Designation |
Junior resident |
| Affiliation |
Government medical college, Kottayam |
| Address |
Dept of Anaesthesia
4th floor
Surgical block
Government medical college, Kottayam
Gandhinagar P. O
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
9995707235 |
| Fax |
|
| Email |
atulcthankachenms07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganga G |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Government medical college, Kollam |
| Address |
Dept of Anaesthesia
Main Campus
Government medical college, Kollam
Parippally P. O
Kollam
Kollam
KERALA
691574
India |
| Phone |
9447961929 |
| Fax |
|
| Email |
gangagdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gincy Ann Lukachan |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Government medical college, Kottayam |
| Address |
Dept of Anaesthesia
4th floor
Surgical block
Government medical college, Kottayam
Gandhinagar P. O
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
9447475818 |
| Fax |
|
| Email |
gincy.luk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Kottayam
Gandhinagar P. O
Kottayam
Pin : 686008
Kerala, India |
|
|
Primary Sponsor
|
| Name |
Dr Atul C Thankachen |
| Address |
Junior Resident
Dept of Anaesthesia
4th floor
Surgical block
Government medical college, Kottayam
Gandhinagar P.O
Kottayam
Pin: 686008 |
| Type of Sponsor |
Other [Self] |
|
|
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 Atul C Thankachen |
Government medical college, Kottayam |
OT complex
Department of Anaesthesia
Government medical college Kottayam
Kottayam
KERALA |
9995707235
atulcthankachenms07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board Government medical college Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients scheduled for elective breast surgeries including Breast-Conserving Surgery and
Sentinel Lymph Node Biopsy, Simple mastectomy, Modified radical mastectomy.
2. American Society of Anaesthesiologists (ASA) grade I or II |
|
| ExclusionCriteria |
| Details |
1. Patients with severe cardiovascular and cerebrovascular disorders.
2. Significant hepatic and renal dysfunction.
3.. History of long term opioid analgesic use.
4. Allergy to local anaesthetics or opioids.
5. Infection at puncture site.
6. Coagulation disorders.
7. Patients undergoing bilateral breast surgeries.
8. Refusal to participate by the patient or family members. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post op analgesia offered by opioid free anaesthesia with PECS- Pecto-Intercostal
Fascial Plane block and opioid based general anaesthesia measured using Numerical Rating
Scale (NRS) at various time-points |
1. Immediately after tracheal extubation
2. One hour
3. Two hour
4. Four hour
5. Eight hour
6. Twenty four hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative opioid consumption in both groups in the first 24 hours post surgery. |
1. Immediately after tracheal extubation
2. One hour
3. Two hour
4. Four hour
5. Eight hour
6. Twenty four hours |
| To assess the time to extubation. |
|
| To assess postoperative nausea and vomiting in the first 24 hour |
|
|
|
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)
|
23/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast cancer surgeries are generally done using strong opioids. However, these drugs carry disadvantages such as postoperative nausea and vomiting, respiratory depression, suppression of immune and gastrointestinal function, which hinder rapid recovery of patients in the early postoperative period. Our objective is to study the immediate patient outcomes using opioid free anaesthesia (OFA) with block and Dexmedetomidine, Ketamine and Magnesium vs conventional opioid based anaesthesia (OBA).
OFA group will receive premedication with dexmedetomidine 0.5 mg/kg and MgSO4 20 mg/kg in 100 ml NS over 10 mins intravenously. After induction patients will be given infusion of dexmedetomidine (1 mcg/ml) with ketamine (1 mg/ml) at 1 ml/10 kg/hr. They will also receive PECS-Pectointercostal Fascial Plane block before the start of surgery.
Conventional OBA group will receive fentanyl at 2 mcg/kg during induction.
Both groups will be induced General Anaesthesia with propofol and vecuronium. Anaesthesia will be maintened with sevoflurane at MAC of 0.8-1.2 in oxygen air mixture. Intra operatively paracetamol and dexamethasone will be given and at the end of surgery reversal will be done with neostigmine and glycopyrrolate. |