| 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
|
|
|
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
|
|
|
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
|
|
|
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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