| CTRI Number |
CTRI/2025/03/081983 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study on Intravenous versus Peri-tumoral Lignocaine Administration in reducing Pro- metastatic Biomarkers in Breast Cancer Patients undergoing surgery: a Step Towards Reducing recurrence |
|
Scientific Title of Study
|
A Pragmatic Randomized Controlled Study on the Efficacy of Intravenous versus Peri-tumoral Lignocaine Administration in Attenuating Pro- metastatic Biomarkers in Breast Cancer Patients undergoing Resection: a Step Towards Reducing recurrence |
| 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 Zainab Ahmad |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhopal |
| Address |
Department of Anesthesiology,
All India Institute of Medical Sciences (AIIMS), Bhopal
Bhopal
MADHYA PRADESH
462024
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
zainaba.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhopal |
| Address |
Department of Anesthesiology,
All India Institute of Medical Sciences (AIIMS), Bhopal
Bhopal
MADHYA PRADESH
462024
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
zainaba.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagat Kanwar |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhopal |
| Address |
PhD supervisor,
Deptt of Biochemistry,
AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9015181711 |
| Fax |
|
| Email |
jagat.BioChemistry@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS) Bhopal, Saket Nagar, Bhopal, MP, India, 462020 |
| Department of Health Research - Indian Council of Medical Research (DHR-ICMR),
2nd Floor, IRCS Building,
1, Red Cross Road,
New Delhi - 110001. |
|
|
Primary Sponsor
|
| Name |
Dr Zainab Ahmad |
| Address |
Additional Professor
Department of Anesthesiology, 3rd floor, Trauma Block,
All India Institute of Medical Sciences (AIIMS) Bhopal, Saket Nagar, Bhopal, MP, India, Pin Code: 462020 |
| 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 Zainab Ahmad |
All India Institute of Medical Sciences (AIIMS), Bhopal |
Modular operation theatres, 2nd and 3rd floors, Hospital Building; Department of Anesthesiolgy, 3rd floor, Trauma Block; Department of Oncosurgery, 3rd floor academic block, Department of General Surgery, 2nd floor academic block and Department of Biochemistry, 3rd floor, Sardar Vallabh bhai Patel Block.
Bhopal
MADHYA PRADESH |
8860048951
zainaba.anesth@aiimsbhopal.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - Student Research |
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 |
| Intervention |
Lignocaine |
Intravenous lignocaine in a dose of 1.5 mg/kg bolus over 10 minutes prior to induction of anesthesia followed by 2.0 mg/kg/hour until skin closure using a programmable infusion pump |
| Intervention |
Lignocaine |
Peri-tumoral Lignocaine infiltration. The dose will be calculated as 4.5 mg/kg (maximum safe dose). Equal volumes of lignocaine (0.5%) will be injected around the tumour using a six-quadrant technique. |
| Comparator Agent |
Normal saline |
Patients will receive normal saline (NS) infusion 1 ml/minute over the first 10 minutes then 5 ml - 10 ml per hour until closure using a programmable infusion pump. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status I- to II, with operable breast cancer Stage I to III |
|
| ExclusionCriteria |
| Details |
Metastatic or recurrent breast cancer, significant comorbidities, contraindications to lignocaine, pregnancy, weight less than 40 kg, preoperative hypotension, immune disorders, or long-term immunosuppressive drug use.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum levels of prometastatic biomarkers - NETosis biomarkers - (H3Cit and MPO) |
Baseline and at 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early cancer recurrence |
2 years or until the end of the study |
| Angiogenesis Biomarkers - MMP 3, VEGF |
baseline and at 24 hours after surgery. |
| Changes in arrays of metabolomic profile and hypoxia inducible factors (HIF) |
baseline and at 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
20/03/2025 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized controlled trial will be conducted at the All India Institute of Medical Sciences (AIIMS) Bhopal, involving departments of anesthesiology, biochemistry, surgery, oncosurgery and translational Medicine. The study will include three parallel arms: IV lignocaine infusion, peri-tumoral lignocaine infiltration, and a control group. A total of 105 patients will be enrolled, with 35 patients in each group. Block randomization will ensure balanced distribution across tumour subtypes. The IV lignocaine group will receive a weight based lignocaine bolus 10 minutes prior to incision followed by continuous infusion until skin closure, while the peri-tumoral group will receive a similar bolus injected around the tumor 10 minutes prior to incision. The control group will receive normal saline. All the groups will also receive evidence based standardised surgical and anesthesia care as defined in the study protocol. Biomarker levels will be measured using commercial ELISA kits, and patients will be followed for at least two years for cancer recurrence. |