| CTRI Number |
CTRI/2019/08/020865 [Registered on: 23/08/2019] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| 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
|
To compare the efficacy of two types of anesthesia techniques on post operative pain relief in patients undergoing breast cancer study |
|
Scientific Title of Study
|
To compare the efficacy of opioid free general anesthesia with opioid based general anesthesia on post operative morphine consumption in patients undergoing breast cancer surgery: a prospective 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 |
Riniki Sarma |
| Designation |
Senior Resident (DM) Onco-Anaesthesia |
| Affiliation |
Dr BRA IRCH, AIIMS |
| Address |
Department of Onco anesthesia and palliative medicine, Dr BRAIRCH, AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
8447456976 |
| Fax |
|
| Email |
riniki_rs@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr BRA IRCH |
| Address |
Room No- 139, 1st Floor, Department of Onco-anaesthesia and palliative medicine, Dr BRA IRCH, AIIMS
South West
DELHI
110029
India |
| Phone |
9013310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riniki Sarma |
| Designation |
Senior Resident (DM) Onco-Anaesthesia |
| Affiliation |
Dr BRA IRCH, AIIMS |
| Address |
Depatment of Onco anaesthesia and palliative medicine, Dr BRAIRCH, AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
8447456976 |
| Fax |
|
| Email |
riniki_rs@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco anaesthesia and palliative medicine,Dr BRA IRCH,AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr BRA IRCH AIIMS New Delhi |
| Address |
Dr BRA IRCH, AIIMS, New Delhi,
Pin-110029 |
| 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 |
| Riniki Sarma |
Dr BRA IRCH, AIIMS, New Delhi |
Department of Onco-anaesthesiology and palliative medicine, Dr BRA IRCH, AIIMS, New Delhi
South West
DELHI |
8447456976
riniki_rs@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research, AIIMS, Ansari nagar, New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (7) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (8) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (9) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid based general anesthesia |
All patients in this group will receive fentanyl 2 mcg/kg, five minutes prior to induction of general anesthesia and repeated every one hour with 1 mcg/kg fentanyl. BIS value will be maintained between 50-60. If tachycardia with BIS in targeted range is present then 20 mcg fentanyl will be given repeated upto a maximum of three times. |
| Intervention |
Opioid free general anesthesia |
All patients in this group will receive Erector spinae plane block before induction. Dexmedetomidine infusion 0.5 mcg/kg/hr will be started 10 minutes prior to induction and continued throughout the intra operative period in a range of 0.3-0.7 mcg/kg/hr.Magnesium sulfate 40 mg/kg will be given over 10 minutes after induction. BIS value will be maintained between 50-60. if tachycardia with BIS in targeted range is present then after maximum dose of dexmedetomidine infusion is reached,ketamine 10 mg bolus will be given till a maximum of 0.5 mg/kg of ketamine is given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18-7O years
2. ASA I and II
3. Patients posted for breast cancer surgery
4. Patients giving written informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
3. Patients with BMI > 35kg/m2
4. Patient with infection at the site of injection
5. Coagulopathy
6. Spine deformity
7. Drug addicts or history of opioid dependence
8. Patients with history of allergy to opioids,local anaesthetics or magnesium.
9. Patients with myopathy or neuropathy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesic efficacy in terms of total postoperative morphine consumption in 24 hours |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NRS pain score |
0,30 min, 1hr. 2hr, 6hr, 24hr post operatively. |
| Patient satisfaction in a likert scale of 1-7 |
24 hours post operatively |
| Neutrophil-Lymphocyte ratio (NLR), Platelet Lymphocyte Ratio (PLR) and number of Natural Killer Cells (NKCs), T helper cells, cytotoxic T cells |
1 day prior to surgery, immediate post operative period, 24 hours post operatively |
| Side effects if any |
0, 30 min, 1 hr, 2 hr, 6 hr, 24 hr post operatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2019 |
| Date of Study Completion (India) |
28/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/02/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute postoperative
pain due to ineffective pain control is a major risk factor for the development
of chronic pain after breast surgery. Opiods has been an integral part of pain management during the perioperative period. But, in recent times, there has been a move
toward opioid‑free anesthesia (OFA) to achieve the goals of hypnosis with
amnesia and sympathetic stability without the adverse effects of opioids like
respiratory depression, excessive sedation, pruritus and nausea vomiting.
Various methods, such as regional blocks, and drugs, such as lignocaine,
dexmedetomidine, ketamine, etc., can be employed to preclude the use of opioids.
There is very limited data on the use of opioid free anesthesia in breast
surgery. Hence in this study we plan to compare the analgesic efficacy of opioid free general anesthesia with opioid based general anesthesia in patients undergoing breast cancer surgery. |