| CTRI Number |
CTRI/2020/06/025582 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO compare the effect of technique of pain relief on recurrence of cancer after breast surgery |
|
Scientific Title of Study
|
Effect of Regional Anaesthesia on immune
response, recurrence and metastasis in 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 |
Nishkarsh Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS |
Ansari Nagar, New Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nishkarsh Gupta |
All India Institute of Medical Sciences |
Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH,Ansari Nagar
South
DELHI |
9013310014
drnishkarsh@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics committe |
Approved |
| Institute Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group GA (general anesthesia group) |
Patients will standard GA technique |
| Intervention |
Group RA (regional analgesia group) |
Patients will receive US guided regional block
along with general anesthesia (GA) using 10 cm (100 mm) needle |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA physical status III or less
2. Primary breast cancer for unimastectomy/breast
conservation surgery
4. With or without lymph node dissection
5. Women younger than 75 years
|
|
| ExclusionCriteria |
| Details |
age more than 75 years
ASA status IV or more
Patient refusal
Coagulopathy
Patients with history of allergy to study drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-occurrence of breast cancer at the end of 3-years |
Patients will be examined every six months till three years to screen for local and systemic breast cancer recurrence by clinical assessment at the end of 3-years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Biochemical recurrence
2. Persistent postoperative pain |
1. blood test will be done baseline, after completion of surgery and after 24 hours.
2. pain will be assessed e (0 min),30 min, 1 hour, 24 hours, 1 month, 6 month and 12 month. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
15/06/2020 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast cancer is increasingly becoming the most common cancer among females in India
(25%–32% as per the National Cancer Registry). The breast cancer surgery is frequently
associated with postoperative pain, postoperative nausea and vomiting (PONV) which may
increase suffering and prolong the hospital stay.
Perioperative pain management can be provided by use of intravenous drugs (opioids,
NSAIDS and paracetamol) which may lead to side effects like sedation, respiratory
depression, PONV, hypotension, bradycardia, pruritus et. Moreover, in recent years use of
opioids has been linked to influence cancer recurrence. Many regional anesthetic (RA) techniques have been used for breast surgeries; these include
local wound infiltration, thoracic epidural anesthesia, thoracic paravertebral block, and more
recently, ultrasound (US)-guided interfacial plane blocks such as pectoral nerve block,
serratus anterior plane block and erector spinae plane block. The beneficial effects of RA
include decreased need for opioids for controlling post-operative pain, decreased PONV and
decreased duration of hospital stay. RA may also reduce cancer progression by attenuation of
the surgical stress response and by the direct protective action of local anesthetics on cancer
cells migration. However, the beneficial effects of RA have been shown in a few
retrospective studies. Considering the magnitude of the disease and possible beneficial effects
of RA in our country, the results may be different than what we may get from ongoing trials.
So, we want to conduct a prospective randomized control trial to show the effectiveness of
RA in biochemical and clinical recurrence in patients undergoing breast cancer surgeries. Women younger than 75 years of ASA physical status III or less with primary breast
cancer limited to breast and axillary nodes (tumor stage 1-3 and nodes 0-2) schedules
for unilateral mastectomy with or without nodal dissection and give consent will
divided into two groups:
Group RA (regional analgesia group): Patients will receive US guided regional block
along with general anesthesia (GA) using 10 cm (100 mm) needle.
Group GA (general anesthesia group): Patients will standard GA technique. In the operation theatre, standard monitors will be
attached and parameters will be recorded. Fentanyl-propofol-rocuronium based anesthetic technique will be used in all patients and airway will be
secured using an appropriate size supraglottic airway. 2 ml of blood sample will be taken one day prior to surgery to know the baseline
values of Neutrophil Lymphocyte Ratio (NLR), Platelet Lymphocyte Ratio (PLR),
number of T helper cells, Natural Killer Cells (NKC) and cytotoxic T cells. The same
blood investigations will be repeated after patient is shifted to recovery room and after
24 hours of surgery. The patients will
be followed at six-month interval for a period of 3 years to see for local or systemic
recurrence.
|