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CTRI Number  CTRI/2024/07/070226 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   TO COMPARE THE POSTOPERATIVE PAIN AMONG PATIENTS RECEIVING DIFFERENT ANAESTHESTHIC MODALITIES AFTER MODIFIED RADICAL MASTECTOMY (MRM) 
Scientific Title of Study   Effectiveness of Local Anaesthetic Drug Mixture Infiltration through Surgical Drains (Drain Block) versus Serratus - lntercostal Fascial Plane Block (SIFB) and Parenteral Paracetamol after Modified Radical Mastectomy (MRM)-a three arm Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CNCI-IEC-SM-2024-134  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sourav Mondal 
Designation  Specialist Grade II 
Affiliation  Chittaranjan National Cancer Institute 
Address  CAMPUS 1 37, S.P. MUKHERJEE ROAD, KOLKATA
CAMPUS 2 STREET NO. 299, PLOT NO. DJ-01, OPREMISES 02-0321, ACTION AREA 1D, NEWTOWN, 700156
South Twentyfour Parganas
WEST BENGAL
700056
India 
Phone  9674366842  
Fax    
Email  sourav2060@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Deepanwita Das 
Designation  Specialist Grade II 
Affiliation  Chittaranjan National Cancer Institute 
Address  37 S P Mukherjee Road

South Twentyfour Parganas
WEST BENGAL
700056
India 
Phone  08910130112  
Fax    
Email  deepanwita.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ipsita Bagchi 
Designation   
Affiliation  R. N. College and school of Nursing 
Address  347/1 Kendua Main Road

South Twentyfour Parganas
WEST BENGAL
700084
India 
Phone  9051908111  
Fax    
Email  ipsitaonline2020@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Chittaranjan National Cancer Institute 
Address  37, S.P.Mukherjee Road, Kolkata-700026, West Bengal, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepa Chakrabarti  Chittaranjan National Cancer Institute  Department of Anaesthesiology and Critical Care 37, S.P.Mukherjee Road
Kolkata
WEST BENGAL 
9830068348

deepajayanta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Chittaranjan National Cancer Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drain Block  Wound infiltration of local anaesthetic mixture through surgical drains 
Comparator Agent  Parenteral Paracetamol  Intravenous paracetamol 
Intervention  SIFP block  USG guided Serratus anterior intercostal Fascial Plane Block with local anaesthestic drug mixture 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Inclusion criteria:

a. Adult female patients planned for MRM

b. Willingness to participate 
 
ExclusionCriteria 
Details  Patients with known allergy to local anaesthetic drugs, patients posted for bilateral MRM in the same sitting, or for pedicle flap or implant reconstruction along with breast oncosurgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative analgesic outcome between Drain Block, SIFB and Parenteral Paracetamol  1 year duration 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the ease of administration of postoperative analgesia between different groups

2. To determine the requirement of rescue analgesics between different groups 
Postoperatively 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   10/07/2024 
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)
Modification(s)  
Not Applicable 
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
Modification(s)  
.
STUDY PROCEDURE:

After getting clearance from the institutional ethics committee (IEC) and the academic committee, the proposed study will be conducted at Chittaranjan National Cancer Institute, on 93 female patients diagnosed with breast cancer posted for MRM, randomized into 3 groups of 31 patients each, by using AI generated randomization software. Appropriate informed consent will be taken from all the patients. After proper preoperative evaluation, the patients will be shifted to the OT, on the day of surgery. The standard monitors including ECG, pulse oximeter, NIBP and temperature will be attached. Injection Paracetamol 15 mg/kg will be given to all patients 1 hour before the start of surgery, as pre-emptive analgesic. A conventional balanced general anaesthesia will be administered to all patients. Premedication consisting of injection fentanyl (2mcg/kg b.w) and loxicard 2% 2 ml, will be given. Induction will consist of injection Propofol (2 mg/kg b.w). After ensuring adequacy of bag mask ventilation, muscle relaxant (injection Atracurium 0.5 mg/kg) will be given. Second generation supraglottic airway will be placed, and will be confirmed by capnography. IPPV will be initiated and will be maintained with gas mixture of oxygen, air and sevoflurane, along with supplements of atracurium (0.1 mg/kg b.w). After completion of surgery, two surgical drains will be placed, in the pectoral and the axillary regions by the surgeon, as per institutional protocol. The Group D patients, will receive Drain Block with 2% lignocaine (4 mg/kg b.w), 0.5%
isobaric bupivacaine (2 mg/kg bw) and 2 ml (500mg/ml) of MgSO4, divided equally in either surgical drains (total volume 40 ml). After completion of wound instillation, the drains will be clamped for twenty minutes, following which they will be de-clamped. The patients belonging to Group S will receive ultrasound guided SIFB with of 2% lignocaine (4 mg/kg), 0.5% isobaric bupivacaine (2 mg/kg) and 2 ml (500 mg/ml) of MgSO4 (total volume 40 ml). The patients belonging to Group C will be the control group and will only receive paracetamol (15 mg/kg b.w) 8 hourly. The time required for the administration of group specific analgesic intervention will be duly recorded using a digital stopwatch.
After completion of the procedure, injection ondansetron 4 mg will be given. Reversal of neuromuscular blockade will be done using injection neostigmine (0.05mg/kg b.w) and glycopyrrolate (0.01mg/kg b.w). After extubation, the range of motion and the pain score (both static and dynamic) will be assessed using goniometer and VAS respectively. Thereafter, the patients will be shifted to postoperative care unit (PACU) for observation.
Subsequent range of motion and the pain scores will be documented at 4, 8, 12, 18 and 24 hours post extubation. Intravenous injection tramadol (2 mg/kg b.w) will be reserved as rescue analgesic and will be administered if and when VAS exceeds 4. The timing of the first requirement and the total cumulative requirement of the rescue analgesic for the first 24 hours will be documented.



 
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