| CTRI Number |
CTRI/2025/12/098676 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to find which sitting position makes spinal needle insertion easier |
|
Scientific Title of Study
|
Comparison of Traditional sitting position, cross legged position, squatting position for ease of spinal needle insertion in patients undergoing spinal anesthesia :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 |
Dr saikrishna |
| Designation |
Junior resident Anesthesia department |
| Affiliation |
Rohilkhand medical College and hospital anesthesia department |
| Address |
Roon no 42 pg boys hostel Rohilkhand medical College and hospital Bareilly
Pilibhit bypass road Bareilly uttarpradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
6303765201 |
| Fax |
|
| Email |
kasaranenisaikrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drsaikrishna |
| Designation |
Junior resident Anesthesia department |
| Affiliation |
Rohilkhand medical College and hospital anesthesia department |
| Address |
Roon no 42 pg boys hostel Rohilkhand medical College and hospital Bareilly
Pilibhit bypass road Bareilly uttarpradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
6303765201 |
| Fax |
|
| Email |
kasaranenisaikrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drsaikrishna |
| Designation |
Junior resident Anesthesia department |
| Affiliation |
Rohilkhand medical College and hospital anesthesia department |
| Address |
Roon no 42 pg boys hostel Rohilkhand medical College and hospital Bareilly
Pilibhit bypass road Bareilly uttarpradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
6303765201 |
| Fax |
|
| Email |
kasaranenisaikrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital Pilibhit bypass road uttar pradesh bareilly |
|
|
Primary Sponsor
|
| Name |
Dr saikrishna |
| Address |
Rohilkhand medical College and hospital Pilibhit bypass road Bareilly uttar pradesh 243006 |
| Type of Sponsor |
Other [Self] |
|
|
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 Neeharika arora |
Rohilkhand medical college and hospital Bareilly |
Department of Anesthesiology rohilkhand medical college and hospital Pilibhit bypass road uttar pradesh 243006 india
Bareilly
UTTAR PRADESH |
8077104070
docneehars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committe rmch barielly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asa grade 1 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pateint undergoing lower Abdominal or lower limb surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1 pateint with supine abnormalities
2 pateint with infection at puncture site
3 pateint with abnormalities
4 pateint with unable to assume any of the required position |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess Difficulty of landmark palpitation
2. Number of needle redirections and attempts required for successful spinal needle insertion.
3. Number of needle bone contacts during the procedure
4.Time taken for successful spinal needle insertion.
5. Post dural puncture headache Complication yes/no
|
At the time of giving spinal anesthesia and patient position ing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
18/12/2025 |
| 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="0"
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
|
Despite the potential benifit the squatting and cross legged position are not widely adopted in clinical guidelines largely due to the lack of strong comparatively research on these position this highlights the need for well designed studies that assess and compare these three position in terms of factor like the ease of spinal needle insertion the number of attempts needed procedure time and complications |