| 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
|
|
|
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
|
|
|
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
|