| CTRI Number |
CTRI/2025/08/093682 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| 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 to see whether sitting cross-legged or sitting normally makes it easier and safer for doctors to give spinal anesthesia, using ultrasound to look at the spine |
|
Scientific Title of Study
|
Evaluation of ultrasonograhic anatomy of spine and ease of spinal needle insertion in traditional sitting position versus cross leg sitting position in patients undergoing spinal anaesthesia - a randomized controlled trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayadevi R |
| Designation |
Post graduate |
| Affiliation |
Sri venkateshwaraa medical college hospital and research center |
| Address |
13A pondy villupuram main road
ariyur
puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9585735725 |
| Fax |
|
| Email |
jayadeviram96@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr jayashridevi |
| Designation |
Professor |
| Affiliation |
Sri venkateshwaraa medical college hospital and research center |
| Address |
No 13A pondy villupuram main road
ariyur
puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr jayashridevi |
| Designation |
Professor |
| Affiliation |
Sri venkateshwaraa medical college hospital and research center |
| Address |
No 13A pondy villupuram main road
ariyur
puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwara medical College hospital and research centre,
13 A Pondy Villupuram main road,
Ariyur
Puducherry,
605102 |
|
|
Primary Sponsor
|
| Name |
Dr Jayadevi R |
| Address |
Department of Anaesthesiology, OT complex, Sri Venkateshwara medical College hospital and research centre
13 A Pondy Villupuram main road
Ariyur
Puducherry
605102 |
| 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 Jayadevi R |
Department of Anesthesiology, Sri venkateshwaraa medical college hospital and research centre |
Room no 13A pondy villupuram main road,
ariyur,
puducherry
Pondicherry
PONDICHERRY |
9585735725
jayadeviram96@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTTEE(HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cross leg sitting position |
In Group B, the patient will be asked to sit in Cross leg Sitting Position with knee and hip flexed and hugging a pillow and an ultrasound assessment of the spine space will be done similarly |
| Intervention |
Traditional sitting position |
In Group A, the subject will be seated in Traditional Sitting Position (TSP) with legs hanging by the side of the bed with feet propped up on a chair and hugging a pillow. Then, a curvilinear probe (Sonosite 5-2 MHz) of portable ultrasound machine will be placed over the spine in midline to get a median sagittal spinous process view. The crescent- shaped hyperechoic reflections of the spinous processes and the Interspinous space will be identified. The Interspinous Space will be measured as the distance between the caudal border of the upper spinous process and the cranial border of the lower spinous process will be measured in the median sagittal interspinous view.
Later, the same ultrasound will be used for the pre-procedural marking. A sagittal oblique view of the spine was obtained, and the L3-L4 interspinous space with best image of the anterior complex (anterior dura mater, posterior longitudinal ligament and body of corresponding vertebra) posterior complex (ligamentum flavum and posterior dura mater) will be obtained.
At this selected interspace, the probe will be positioned in transverse view and a skin marker will be used to mark the midpoint of the long and short borders of the probe. The point of intersection of both lines will be identified as the needle entry point. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgeries under spinal anaesthesia.
Age group 18-65 years.
Belonging to American society of Anaesthesiologists (ASA) class I and II.
|
|
| ExclusionCriteria |
| Details |
Contraindications to spinal anaesthesia
Class II obese
Emergency surgeries under spinal anaesthesia
Elective or Emergency Caesarean section surgeries under spinal anaesthesia
Inability to sit in Traditional sitting position or Cross leg sitting position
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Linear distance between adjacent spinous processes at the L3–L4 interspace on standardized longitudinal paramedian ultrasound view. Record the largest clearly obtained value (in mm) |
Approximately 20 minutes after the procedure is done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of needle insertion attempts-count each fresh skin puncture
Number of needle passes-count redirections without withdrawing completely from skin
Space identification time(seconds)-form ultrasound probe first contact with skin(in assigned position) to final marking of L3-L4
Time to successful lumbar puncture(seconds)
|
Approximately 20 minutes after the procedure is done |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
09/09/2025 |
| 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
|
This randomized controlled trial aims to evaluate the effect of patient positioning on ease of spinal anaesthesia. In 76 patients undergoing spinal anaesthesia will be allocated to either the traditional sitting position or the cross-leg sitting position. Pre-procedural ultrasound of the lumbar spine will be performed to assess the interspinous space at L3–L4. The primary outcome is the interspinous space distance measured by ultrasound. Secondary outcomes include number of insertion attempts, number of needle passes, space identification time and time required for successful lumbar puncture. The study will help determine whether the cross-leg sitting position provides any advantage over the traditional sitting position in facilitating spinal needle insertion. |