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CTRI Number  CTRI/2026/02/102680 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Lowe back bone injection use as alternative to complete anaesthesia for breast cancer surgeries offering faster recovery and fewer side effects 
Scientific Title of Study   Lumbar spinal anaesthesia for malignant breast surgeries revisiting an unconventional approach-A case series” 
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 Ramesh Koppal  
Designation  Professor  
Affiliation  S Nijalingappa medical college Bagalkot  
Address  Department of Anaesthesia S Nijalingappa medical college Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Koppal  
Designation  Professor  
Affiliation  S Nijalingappa medical college Bagalkot  
Address  Department of Anaesthesia S Nijalingappa medical college Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramesh Koppal  
Designation  Professor  
Affiliation  S Nijalingappa medical college Bagalkot  
Address  Department of Anaesthesia S Nijalingappa medical college Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Source of Monetary or Material Support  
SN medical college and RC NAVANAGAR BAGALKOTE India Pain code -587103 
 
Primary Sponsor  
Name  SNMC  
Address  S N MEDICAL COLLEGE AND RC Navanagar near APMC YARD BAGALKOTE India 587103 
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 
Shraddha angadi  S N medical college   Department of anaesthesia Major operation theatre iPad complex
Bagalkot
KARNATAKA 
8792425025

Shraddha199130@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC institutional Ethical committee on human subject research   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 
Intervention  Lumbar spinal anaesthesia for breast surgeries   Spinal anesthesia was administered to the patients in lateral position making operative site dependent using a 26 G Quincke spinal needle in either L3–L4 or L2-L3 interspace after infiltrating skin with lignocaine (2 ml 2percent) on-noticing free flow and aspiration of Cerebrospinal Fluid Hyperbaric Bupivacaine 0.5 percentage heavy with total dose of 4ml (20mg) was injected over period of 6 to 7 minutes along with barbotage technique then patient is made supine after 10 th minutes of lumbar puncture The time of onset level of sensory block was assessed by pinprick test every 5 minutes within first half hour to determine the highest level of sensory blockage Hemodynamic parameters was recorded immediately after administering Spinal Anesthesia followed by every 2 minutes for the first 10 minutes of administering Spinal Anesthesia followed by every 3 min till the next 30 min followed by every 5 minutes until 60 minutes of surgery hypotension was treated with Inj Ephedrine 10mg IV when mean arterial pressure (MAP) decreased 20 percentage or more from baseline . Bradycardia HR of less than50 beats per min if any was treated with Inj Atropine 0.6mg IV The sensory duration of analgesia was defined as the time from administration of spinal anesthesia till the first demand for rescue analgesic when VAS was more or equal 4 All patient were given injection Fentanyl 100 mcg IV before incisions and oxygen was administered at 6L per min using Hudson mask. 
Comparator Agent  Not APPLICABLE  Not applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  ASA1&2 
 
ExclusionCriteria 
Details  Localised infection at the injection site
Raised ICP
Relative spinal contraindications- hypovolumia, aortic stenosis, spina bifilar, coagulopatthy,multiple sclerosis
Autonomic neuropathy-DM,CKD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess Height of anaesthesia (Dermatome level)  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OBJECTIVE :
1. To assess intraoperative hemodynamic variation ( Bradycardia, Hypotension)
2. To observe Respiratory complications ( fall in saturation, breathing difficulties)
3. To assess Duration of analgesia . 
24hour after surgery 
 
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   N/A 
Date of First Enrollment (India)   10/02/2028 
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 Yet Recruiting 
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 surgeries are traditionally conducted under general anaesthesia however it

has its own constraints like airway complications high incidence of nausea and

vomiting and increased length of hospitalisation and cost this created demand for

better approaches like neuraxial anaesthesia 

On exploring neuraxial techniques for breast surgeries thoracic epidural and

thoracic segmental spinal anesthesia showed promising results but these procedures

carried their own risks like hemodymaic instability potential spinal cord injury

respiratory compromise and technical challenges.

Lumbar spinal anaesthesia being simpler safer and more technically accessible

alternative which has been successfully tried for upper abdominal surgeries while

avoiding the complexities and neurological risk associated with thoracic spinal

block but its use in breast surgeries is limited

This study explores the feasibility of lumbar spinal anaesthesia in breast surgeries

including malignant with axillary dissection local anaesthetic administered in

lumbar subarachnoid space followed by barbotage to achieve controlled cephalad

spread satisfactory anaesthesia can be obtained up to required thoracic dermatomes

while ensuring good analgesia stable hemodynamics spontaneous respiration and

patient consciousness 


 
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