| CTRI Number |
CTRI/2024/03/064499 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of ultrasonographic anatomy of spine in traditional sitting position versus crossed leg position |
|
Scientific Title of Study
|
Comparison of ultrasonographic anatomy of spine in traditional sitting position versus crossed leg position in Patients posted for surgery: A prospective, observational, crossover study |
| 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 Haripriya |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Anaesthesia, OT complex,first floor, MVJ medical college and research hospital.
Bangalore
KARNATAKA
562114
India |
| Phone |
8970766376 |
| Fax |
8970766376 |
| Email |
ramachandranharipriya9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haripriya |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Anaesthesia, OT complex,first floor, MVJ medical college and research hospital.
KARNATAKA
562114
India |
| Phone |
8970766376 |
| Fax |
8970766376 |
| Email |
ramachandranharipriya9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haripriya |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Anaesthesia, OT complex,first floor, MVJ medical college and research hospital.
Bangalore
KARNATAKA
562114
India |
| Phone |
8970766376 |
| Fax |
8970766376 |
| Email |
ramachandranharipriya9@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVJ medical college and research hospital, NH4, Kolathur post, Bengaluru, 562114 |
|
|
Primary Sponsor
|
| Name |
Dr Haripriya |
| Address |
MVJ medical college and research hospital |
| 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 Haripriya |
MVJ medical college and research hospital |
Department of Anaesthesia, Pre operative room, OT Complex, First floor.
Bangalore Rural
KARNATAKA |
8970766376
ramachandranharipriya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ Medical college and research hospital |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 - 60 years of both sexes posted for elective surgery.
ASA I- ASA II patients
BMI – 18.5 to 25 Kg/m2
|
|
| ExclusionCriteria |
| Details |
Patient with spine deformities or a history of previous spine surgery,
Inability to sit in TSP or CLSP,
Pregnant patients,
Uncooperative patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of interspinous space using ultrasound assessment of spine in traditional sitting position with crossed leg position |
It is a single point study. Patients will be assessed on the day of the surgery in the pre operative room. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/03/2024 |
| 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
|
The sitting position for neuraxial anaesthesia has gained popularity due to better lumbar flexion and easier identification of landmarks. The literature describes various variants for administering neuraxial anaesthesia in a sitting position, such as the traditional sitting position (TSP), the Hamstring stretch position, the squatting position and the crossed leg sitting position (CLSP).2 The knee and hip flexion in CLSP resulted in posterior pelvic leaning and reduced lumbar lordosis, this would help in ease of identification of landmarks which will help in success of spinal needle insertion.3
|