| CTRI Number |
CTRI/2025/04/084646 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sonographic Measurement of Interspinous Distance in Patients planned for Surgery under Neuraxial Anesthesia |
|
Scientific Title of Study
|
Prospective Observational Study Of Interspinous Distance Of The Lumbar Spine In Different
Positions Using Ultrasonography |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogita Patil |
| Designation |
Professor |
| Affiliation |
Seth G. S. Medical College and King Edward Memorial Hospital |
| Address |
Department of Anesthesiology, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833935747 |
| Fax |
|
| Email |
yogitapatil76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maitri Shah |
| Designation |
Junior Resident |
| Affiliation |
Seth G. S. Medical College and King Edward Memorial Hospital |
| Address |
Department of Anesthesiology, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09930220536 |
| Fax |
|
| Email |
maitrishah720@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maitri Shah |
| Designation |
Junior Resident |
| Affiliation |
Seth G. S. Medical College and King Edward Memorial Hospital |
| Address |
Department of Anesthesiology, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09930220536 |
| Fax |
|
| Email |
maitrishah720@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G.S. Medical College and KEM Hospital, Acharya Donde Marg, Parel Mumbai-400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Yogita Patil |
Seth G. S. Medical College and King Edward Memorial Hospital |
Department of Anesthesiology, PAC Room, Seth GS Medical College and KEM Hospital
Acharya Donde Marg, Parel, Mumbai – 400012. India
Mumbai
MAHARASHTRA |
2410 7000
2414 3435
yogitapatil76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K64||Hemorrhoids and perianal venous thrombosis, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (4) ICD-10 Condition: N99||Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified, (5) ICD-10 Condition: L76||Intraoperative and postproceduralcomplications of skin and subcutaneous tissue, (6) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, (7) ICD-10 Condition: N28||Other disorders of kidney and ureter, not elsewhere classified, (8) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, (9) ICD-10 Condition: N39||Other disorders of urinary system, (10) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for surgery under spinal and epidural anaesthesia willing to give written
informed consent
2. Between ages 18-50 years
3. Able to perform all three position |
|
| ExclusionCriteria |
| Details |
1. BMI more than 30 kg/m 2
2. Scoliosis
3. History of Trauma to the Spine
4. Lower back pain
5. History of Surgery to Hip Or Knee
6. Pelvic or knee problems related to arthropathy
7. Pregnancy
8. Unwilling to participate
9. Unable to perform all 3 positions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identify the position with the maximum interspinous distance at the L3-L4 vertebral level using ultrasonography |
Within 8 weeks after data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the subcutaneous tissue thickness, paraspinal muscle thickness, intrathecal space in
the three positions using ultrasonography |
Within 8 weeks after data collection |
| Identify the position with the maximum patient comfort using 5-point NRS. |
Within 8 weeks after data collection |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
10/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/07/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Neuraxial anaesthesia is one of the most commonly used modes of regional anaesthesia. However, anatomical landmarks based physical assessment has been misleading in 30% of the cases resulting in a failure rate of around 2-20%. Bony structure, spinal anatomy, unidentified anatomical landmarks, excess BMI, inappropriate patient positioning, intervention method, experience of anesthetist, and equipment are considered as reasons of failure. The most important factor affecting success during spinal and epidural interventions is the patient’s positioning. A prosperous positioning of the patient widens the interspinous distance and ensures an increased chance of successful needle placement. Optimally flexed position that reduces lumbar lordosis and opens the intervertebral space may help in reducing the failure rate. A meta-analysis has proven the increased intervention success of neuraxial anaesthesia performed using ultrasonography. This study aims to identify which position, has the maximum interspinous distance and patient comfort; using ultrasonography. |