| 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
|
|
|
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
|
|
|
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
|
|
|
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. |