| CTRI Number |
CTRI/2025/06/089578 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound examination of spine as a predictive tool for difficult spinal anaesthesia |
|
Scientific Title of Study
|
Preoperative ultrasound examination of posterior longitudinal ligament: A screening and predictive tool for difficult 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 |
Suchitra P |
| Designation |
Assistant Professor |
| Affiliation |
Mvj medical college and research hospital |
| Address |
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL, 30TH MILE,KOLATHUR POST,HOSKOTE 562114
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
9731364272 |
| Fax |
|
| Email |
Suchiprakash94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suchitra P |
| Designation |
Assistant Professor |
| Affiliation |
Mvj medical college and research hospital |
| Address |
Mvj medical college and research hospital,30th mile, kolathur post,hoskote
KARNATAKA
562114
India |
| Phone |
9731364272 |
| Fax |
|
| Email |
Suchiprakash94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suchitra P |
| Designation |
Assistant Professor |
| Affiliation |
Mvj medical college and research hospital |
| Address |
Mvj medical college and research hospital,30th mile, kolathur post, hoskote
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
9731364272 |
| Fax |
|
| Email |
Suchiprakash94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Suchitra P |
| Address |
Mvj medical college and research hospital,30th mile, kolathur post,hoskote |
| 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 |
| Suchitra P |
Mvj medical college and research hospital |
1st floor, operation theatre, Mvj medical college and research hospital, 30th mile,kolathur post,hoskote 562114
Bangalore Rural
KARNATAKA |
9731364272
suchiprakash94@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: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
|
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 |
ASA PS grade 1 to 3 and patients willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients with contraindications to spinal anaesthesia, with known spinal deformities or previous spinal surgeries, with pregnancy complications requiring urgent intervention and uncooperative or non consenting patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between posterior longitudinal ligament score and success of spinal anaesthesia |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of the best lumbar level for spinal anaesthesia using posterior longitudinal ligament assessment |
1 year 0 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Ultrasound guidance has emerged as a useful tool for Preoperative assessment. It can help to reduce the multiple needle attempts and help to improve success rates and reduce complications and hence can be used as a screening tool for difficult spinal anaesthesia. |