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CTRI Number  CTRI/2026/02/104721 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
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 effectiveness between Segmental Thoracic Spinal Anaesthesia and General Anaesthesia in patients undergoing Modified Radical Mastectomy 
Scientific Title of Study   Effectiveness of Segmental Thoracic Spinal Anaesthesia Versus General Anaesthesia in patients undergoing Modified Radical Mastectomy: A Randomized 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  Anjali Nagare 
Designation  Junior Resident 
Affiliation  N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospita 
Address  Department of anaesthesiology, N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road Nagpur Maharashtra INDIA

Nagpur
MAHARASHTRA
440016
India 
Phone  9511213227  
Fax    
Email  anjalinagare97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Heena Pahuja 
Designation  Assistant professor  
Affiliation  N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital 
Address  Department of anaesthesiology ,N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road Nagpur Maharashtra INDIA

Nagpur
MAHARASHTRA
440016
India 
Phone  9823188160  
Fax    
Email  heenapahuja15@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Anjali Nagare 
Designation  Junior Resident 
Affiliation  N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Nagpur 
Address  Department of anaesthesiology, N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road Nagpur Maharashtra INDIA

Nagpur
MAHARASHTRA
440016
India 
Phone  9511213227  
Fax    
Email  anjalinagare97@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospita 
Address  N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road Nagpur 440016 Maharashtra INDIA  
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 
Dr Anjali Nagare  N K P Salve Institute Of Medical Sciences and Research Centre Nagpur   Department of Anaesthesiology, 4th floor, N K P Salve Institute Of Medical Sciences and Research Centre, Digdoh Hills, Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA 
9511213227

anjalinagare97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Nagpur  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  General Anaesthesia  Patient will be given standard General Anaesthesia  
Intervention  Segmental Thoracic Spinal Anaesthesia   Under aseptic precautions, segmental thoracic spinal block will be performed at T5–T6 interspace using a 25 G Quincke needle.Using 1 mL of 0.5% isobaric Levobupivacaine + 25 µg Fentanyl (total volume 1.5 mL) in sitting position. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  America society of anaesthesiologist ASA 1 and 2
Body mass index Less than 35
Expected duration of surgery less than 120 mins 
 
ExclusionCriteria 
Details  Patients refusal to participate
History of previous breast cancer
Patient has history of allergy to local Anaesthetics
Patients with mental disorders
Patients with coagulopathy
Patient with infection at site of spinal Anaesthesia
Patients with advanced renal ,hepatic and cardio respiratory disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Is the effectiveness of segmental thoracic spinal Anaesthesia better than general Anaesthesia in patients undergoing modified radical mastectomy with respect to
1. Hemodynamic stability
2. Total blood loss
3. Patient satisfaction score 
1. Hemodynamic parameters will be measured every 5 mins for the first 30 mins then every 15 mins for the remainder of the surgery
2. Total Blood loss will be assessed after the surgery
3. Patient satisfaction score will be measured after the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Is the surgeon satisfaction better with segmental thoracic spinal Anaesthesia than with general Anaesthesia in patients undergoing modified radical mastectomy   Surgeon satisfaction score will be asked after the surgery ends 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   24/03/2026 
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="1"
Months="6"
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  

Breast cancer is one of the most common malignancies affecting women worldwide and remains a major public heal concern. InIndia the incidence of breast cancer is 25.8/1,00,000 population. General anesthesia remains the standard approach for modified radical mastectomy. However, it is associated with higher stress response, post-operative pain, aspiration risk, atelectasis , pneumonia , major adverse cardiac events, longer recovery time, Post Traumatic Stress Disorder.  Regional anesthesia has increasingly gained recognition in recent years. This technique offers several advantages— like reduced surgical stress response, reduced incidence of respiratory and cardiac complications and better pain control, quicker return of bowel function, lower rates of post-operative nausea and vomiting (PONV), reduced risk of thromboembolic events and early patient mobilization. It also provides superior analgesia, and decreased postoperative opioid requirements and better overall patient satisfaction. Advances in anesthesia have played a crucial role in improving patient satisfaction.There is a potential direct inhibitory effect of local anesthetics on cancer cell migration which has encouraged anesthesiologists worldwide to incorporate various regional anesthesia methods into clinical practice .With growing interest in Enhanced Recovery After Surgery (ERAS) protocols and the need to minimize opioid use, Segmental Thoracic Spinal Anaesthesia for modified radical mastectomy presents as a promising approach. However, it requires expertise and also, careful patient selection is essential. Segmental Thoracic Spinal Anaesthesia is a regional anesthesia technique that involves injecting a small volume of local anesthetic into the thoracic subarachnoid space to achieve a targeted and segmental block .This technique allows a more localized anesthesia, minimizing the spread of the block and preserving motor function in unaffected areas, making it a highly targeted and precise form of Anaesthesia .Segmental Thoracic Spinal Anaesthesia offers potential benefits such as stable hemodynamics, reduced postoperative nausea and vomiting(PONV), superior analgesia, quicker recovery and early ambulation and better outcome in terms of peri operative mortality and morbidity compared to general anesthesia. Segmental Thoracic Spinal Anaesthesia is currently being explored as available option for thoracic and upper abdominal procedures. Therefore, we plan to compare the effectiveness of Segmental ThoracicSpinal Anaesthesia and General Anaesthesia in patients undergoing Modified Radical Mastectomy.

 

 
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