| CTRI Number |
CTRI/2025/11/096792 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Awake Breast surgeries under spinal anesthesia |
|
Scientific Title of Study
|
A Prospective Study Of Thoracic Segmental Spinal Anesthesia For Breast And Axillary Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khammam Shyam Sundar |
| Designation |
Post graduate resident |
| Affiliation |
Rajiv Gandhi institute of Medical Sciences Adilabad Telangana |
| Address |
Department of Anesthesiology Operation theatre complex Second
floor Rajiv Gandhi institute of Medical Sciences Adilabad Telangana
504001
Adilabad
TELANGANA
504001
India
Adilabad
TELANGANA
504001
India |
| Phone |
8328477010 |
| Fax |
|
| Email |
kammamshyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Stephen |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi institute of Medical Sciences Adilabad Telangana |
| Address |
Department of Anesthesiology Operation theatre complex Second
floor Rajiv Gandhi institute of Medical Sciences Adilabad Telangana
504001
Adilabad
TELANGANA
50400
Adilabad
TELANGANA
504001
India |
| Phone |
9371231434 |
| Fax |
|
| Email |
shirley81@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Stephen |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi institute of Medical Sciences Adilabad Telangana |
| Address |
Department of Anesthesiology Operation theatre complex Second
floor Rajiv Gandhi institute of Medical Sciences Adilabad Telangana
504001
Adilabad
TELANGANA
50400
TELANGANA
504001
India |
| Phone |
9371231434 |
| Fax |
|
| Email |
shirley81@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi institute of Medical Sciences Adilabad Telangana |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi institute of Medical Sciences Adilabad Telangana |
| Address |
Rajiv Gandhi institute of Medical Sciences Rickshaw colony Adilabad
Telangana 504001 |
| Type of Sponsor |
Government 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 Shirley Stephen |
Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana |
Department of
Anaesthesiology,
Operation theatre
complex Second floor
Rajiv Gandhi Institute of
Medical Sciences
Adilabad Telangana
Adilabad
TELANGANA |
9371231434
shirley81@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana 504001 |
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 anesthesia |
propofol iv stat dose 2mg/kg
nalbuphine iv stat dose 4mg
vecuronium iv 5mg stat
|
| Intervention |
segmental spinal |
Isobaric Levobupivacaine
1.8 - 2.5ml
single stat dose
intrathecal |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of ASA I and II grade, undergoing breast and axilla surgeries |
|
| ExclusionCriteria |
| Details |
Patients with the following conditions will all be excluded -
- Cardiac diseases , Respiratory diseases , Neuropsychiatric disorders
- Obese patients , Obstructive sleep apnea
- Difficult airway , difficult intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset of spinal block, analgesia duration, adverse effects |
start and end of surgery, 2hr, 4hr and 6hr after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
23/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
|