| CTRI Number |
CTRI/2025/12/098698 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Sitting Positions for Easier Spinal Anaesthesia in Lower Body Surgeries. |
|
Scientific Title of Study
|
Comparison Of Spinal Needle Placement Success In Traditional Sitting Position And Knee-Chest Sitting Position In Patients Undergoing Infraumblical Surgeries Under Spinal Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Jagota |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesia and intensive care, Main OT building, Room number 1, Division 1, Ground floor, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi South DELHI 110029 India
South
DELHI
110029
India |
| Phone |
8766316602 |
| Fax |
|
| Email |
apoorva.jagota99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Faculty Room Department of anaesthesia and intensive care Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi South DELHI 110029 India
South
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Faculty Room Department of anaesthesia and intensive care Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi South DELHI 110029 India
South
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, South Delhi, Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Office of the H.O.D. Department of Anaesthesiology and intensive care Vardhman Mahavir Medical College and Safdarjung hospital New Delhi India 110029 |
| 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 |
| Apoorva Jagota |
Vardhman Mahavir Medical College and Safdarjung Hospita |
Department Of Anaesthesia and intensive care, Main OT building, Room number 1, Division 1, Ground floor, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi South DELHI
South
DELHI |
8766316602
apoorva.jagota99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vardhman Mahavir Medical and Safdarjung Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: S961||Injury of muscle and tendon of long extensor muscle of toe at ankle and foot level, (4) ICD-10 Condition: S960||Injury of muscle and tendon of long flexor muscle of toe at ankle and foot level, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: S833||Tear of articular cartilage of knee, current, (8) ICD-10 Condition: S832||Tear of meniscus, current injury, (9) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
knee chest sitting position |
2-3ml of 0.5% hyperbaric Bupivacaine administered in L3-L4 inter-vertebral space in a position where knees and hips are flexed while patient is sitting and knees touching the chest |
| Comparator Agent |
traditional sitting position |
2-3ml of 0.5% hyperbaric Bupivacaine administered in L3-L4 inter-vertebral space in patient sitting on table with legs resting on stool |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-60 years, ASA status of I and II, Undergoing infraumbilical surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients unable to sit in study position, any contraindication to spinal Anesthesia, BMI more than 30kg per meter square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare spinal needle placement success in knee-chest sitting position and traditional sitting position in patients undergoing infraumbilical surgeries under spinal anesthesia |
5 seconds after placing spinal needle and confirmation by free flow of cerebrospinal fluid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare effect of knee-chest sitting position with traditional sitting position in patients undergoing
infraumbilical surgeries under spinal anesthesia, on ease of landmark palpation, number of attempts. |
5 seconds after spinal needle placement |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 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
|
This randomized comparative study evaluates spinal needle placement success in knee-chest sitting versus traditional sitting positions in adults undergoing infraumbilical surgeries under spinal anesthesia. A total of 104 patients will be randomly assigned to either position. The primary outcome is first-attempt success, with secondary outcomes including ease of landmark palpation and number of attempts. By assessing whether the knee-chest position improves lumbar flexion and facilitates easier needle placement, the study aims to identify the more effective patient position for spinal anesthesia. |