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CTRI Number  CTRI/2025/08/092730 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 10/08/2025
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   A study comparing two anesthesia methods (Thoracic Segmental Spinal Anesthesia and Erector Spinae Plane Block) for pain relief after breast cancer surgery (modified radical mastectomy) 
Scientific Title of Study   Comparative study of Thoracic Segmental Spinal Anesthesia and Erector Spinae Plane Block for modified radical mastectomy: A randomized controlled clinical 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 Nunna Mounika 
Designation  PG Resident 
Affiliation  Institute of medical sciences and sum hospital, Siksha O anusandhan 
Address  Department of Anesthesiology, Modular OT 3 complex, first floor, institute of medical sciences and sum hospital, Siksha o Anusandhan, Khordha, Odisha, India, 751003

Khordha
ORISSA
751003
India 
Phone  7702386784  
Fax    
Email  mounikanunna01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavna Sriramka 
Designation  Professor 
Affiliation  Department of Anesthesiology, Modular OT 3 complex, first floor, institute of medical sciences and sum hospital, Siksha o Anusandhan, Khordha, Odisha, India, 751003 Institute of medical sciences and sum hospital, Siksha O anusandhan Khordha ORISSA 751003 
Address  Department of Anesthesiology, Modular OT 3 complex, first floor, institute of medical sciences and sum hospital, Siksha o Anusandhan, Khordha, Odisha, India, 751003
Institute of medical sciences and sum hospital, Siksha O anusandhan
Khordha
ORISSA
751003
India 
Phone  94060333609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavna Sriramka 
Designation  Professor 
Affiliation  Department of Anesthesiology, Modular OT 3 complex, first floor, institute of medical sciences and sum hospital, Siksha o Anusandhan, Khordha, Odisha, India, 751003 Institute of medical sciences and sum hospital, Siksha O anusandhan Khordha ORISSA 751003 
Address  Department of Anesthesiology, Modular OT 3 complex, first floor, institute of medical sciences and sum hospital, Siksha o Anusandhan, Khordha, Odisha, India, 751003
Institute of medical sciences and sum hospital, Siksha O anusandhan
Khordha
ORISSA
751003
India 
Phone  94060333609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM Hospital, Siksha O Anusandhan university, K8,Kalinga Nagar, Bhubaneswar, Odisha, India Pin Code - 751003  
 
Primary Sponsor  
Name  Institute of medical sciences and sum hospital 
Address  K8, Kalinga nagar, Bhubaneswar, Odisha, PIN: 751003 
Type of Sponsor  Private 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 
DrNunna Mounika  Institute of medical sciences and sum hospital, Siksha O anusandhan  Department of Anesthesiology, Modular OT 3 Complex, First Floor, Institute of Medical Sciences and SUM Hospital, Siksha ‘O’ Anusandhan (Deemed to be University), K8, Kalinganagar, Bhubaneswar, Khordha, Odisha, India, PIN 751003
Khordha
ORISSA 		 7702386784

mounikanunna01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Ims and Sum Hospital, BHubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector Spinae Plane Block (ESPB)   : Patients receive ESPB at T5 under ultrasound guidance with 20 ml of 0.2% ropivacaine plus 0.5 mcg/kg dexmedetomidine injected on the surgical side.  
Intervention  Thoracic Segmental Spinal Anesthesia (TSSA)  Patients receive TSSA at T4–T5 interspace with 1.5 ml of 0.2% isobaric ropivacaine plus 5 mcg dexmedetomidine.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Patients willing to participate with written informed consent.
2. ASA grade I and II.
3. Patients age more than 18 years.
4. Patients undergoing modified radical mastectomy.
 
 
ExclusionCriteria 
Details  1. ASA grade more than II.
2. Thrombocytopenia or coagulopathy.
3. Local site infection.
4. Spinal or chest deformity.
5. Surgery duration expected to exceed 3 hours.
 
 
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 
Comparison of postoperative pain scores (VAS) between Group TSSA and Group ESPB.  after 30 minutes and 2 hours post extubation  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events (hypotension, bradycardia, nausea, vomiting, block-related complications).  at 12 hours post operatively & at 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 4 
Date of First Enrollment (India)   26/08/2025 
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="1"
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  
This prospective randomized controlled trial compares thoracic segmental spinal anesthesia (TSSA) with erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing modified radical mastectomy. Ninety ASA I and II patients aged above 18 years will be randomized into two groups: Group TSSA receiving 1.5 ml of 0.2% isobaric ropivacaine with 5 mcg dexmedetomidine at T4–T5 interspace, and Group ESPB receiving 20 ml of 0.2% ropivacaine with 0.5 mcg/kg dexmedetomidine at T5 level under ultrasound guidance. Primary outcome is postoperative pain scores measured by VAS at 30 minutes and 2 hours. Secondary outcomes include time to first analgesia, rescue analgesic requirements, and incidence of complications. Randomization uses computer-generated numbers with sealed opaque envelope concealment; outcome assessor will be blinded. Statistical analysis includes Mann-Whitney U test, unpaired t-test, and Chi-square test. The study aims to evaluate which regional technique provides superior postoperative analgesia in breast cancer surgeries.

 
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