| CTRI Number |
CTRI/2026/03/106410 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| 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
|
Comparison of two Ultrasound guided nerve blocks for pain relief after breast cancer surgery |
|
Scientific Title of Study
|
comparative study of ultrasound guided STIL (subtransverse interligamentary) vs ESP block (erector spinae plane) in patients undergoing MRM (modified radical mastectomy) at tertiary care hospital in Eastern India:A Randomised controlled trial. |
| 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 MONISHA PATRA |
| Designation |
ACADEMIC JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KALYANI |
| Address |
DEPARTMENTOFANAESTHESIA,1ST FLOOR, IPD BUILDING,AIIMS KALYANI,NH-34 CONNECTOR,, BASANTAPUR,SAGUNA,KALYANI,DISTRICT NADIA,WEST BENGAL 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
9123352053 |
| Fax |
|
| Email |
monisha.anaesth_acjr25@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. KUMARI SNEHA |
| Designation |
ASSOCIATE PROFESSOR , DEPARTMENT OF ANAESTHESIA |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KALYANI |
| Address |
DEPARTMENTOFANAESTHESIA,1ST FLOOR, IPD BUILDING,AIIMS KALYANI,NH-34 CONNECTOR,, BASANTAPUR,SAGUNA,KALYANI,DISTRICT NADIA,WEST BENGAL 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
9818234861 |
| Fax |
|
| Email |
kumari.anesth@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. KUMARI SNEHA |
| Designation |
ASSOCIATE PROFESSOR , DEPARTMENT OF ANAESTHESIA |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KALYANI |
| Address |
DEPARTMENTOFANAESTHESIA,1ST FLOOR, IPD BUILDING,AIIMS KALYANI,NH-34 CONNECTOR,, BASANTAPUR,SAGUNA,KALYANI,DISTRICT NADIA,WEST BENGAL 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
9818234861 |
| Fax |
|
| Email |
kumari.anesth@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| CENTRAL PHARMACY,1ST FLOOR,AIIMS Kalyani,NH-34 connector, Basantapur, saguna,kalyani, district Nadia, West Bengal 741245 |
|
|
Primary Sponsor
|
| Name |
Dr MONISHA PATRA |
| Address |
MARRIED HOSTEL, AIIMS KALYANI NH-34 CONNECTOR, BASANTAPUR, SAGUNA, KALYANI, NADIA,WEST BENGAL 741245 |
| 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 MONISHA PATRA |
AIIMS KALYANI |
DEPARTMENT OF ANAESTHESIOLOGY,1ST FLOOR IPD BUILDING,NH-34 CONNECTOR BASANTAPUR SAGUNA KALYANI NADIA WEST BENGAL 741345
Nadia
WEST BENGAL |
9123352053
monisha.anaesth_acjr25@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
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 |
ultrasound guided STIL (subtransverse interligamentary) |
20ml of 0.2% Ropivacaine with4mg dexamethasone in each group |
| Comparator Agent |
ESP block (erector spinae plane) in patients undergoing MRM (modified radical mastectomy) |
20ml of 0.2% Ropivacaine with4mg dexamethasone in each group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients aged 18-65years, undergoing Modified Radical Mastectomy(MRM) under GA.
2. American Society of Anesthesiologist (ASA) performance status I and II patients. |
|
| ExclusionCriteria |
| Details |
Refusal to participate in the study, obese patients BMI more then 35kg/m2, patients with local infection at needle insertion site, patient with history of psychiatric illness and on antipsychotic medications, patient with history of chronic pain. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of postoperative pain, documented as NRS (Numeric Rating Scale) after STIL and ESP block in patient undergoing MRM surgery |
after administration of block, comparison of intraoperative SBP,HR and postoperative pain scores at 0,2,6,12 and 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of time of first rescue analgesia, time taken for each procedure, intraoperative opioid requirement, total analgesic consumption, patient satisfaction score. |
comparison of intraoperative rescue analgesia requirement |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
27/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
It is a prospective, randomized, double blinded comparative study to compare the analgesic efficacy of STIL vs ESP block in patients undergoing MRM (modified radical mastectomy) at tertiary care hospital in Eastern India. Parameters that will be compared between the two groups will be the comparison of time to first rescue analgesia, time taken for each procedure, intraoperative opioid requirement after surgical incision, total analgesic consumption, patient satisfaction score according to Likerts scale. |