| CTRI Number |
CTRI/2025/03/083196 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting difficulty in spinal anaesthesia: A study on spinous process and BMI in lower limb and lower abdominal surgeries at SMS Medical College,Jaipur |
|
Scientific Title of Study
|
A Prospective observational study to predict difficulty score for spinal anaesthesia by spinous process and body mass index in patients undergoing lower limb and lower abdominal sugery at SMS Medical College,Jaipur |
| 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 Shriphal Meena |
| Designation |
Senior Professor |
| Affiliation |
Department Of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jaipur |
| Address |
Department Of Anaesthesia
Sawai Man Singh Medical College
and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
09928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriphal Meena |
| Designation |
Senior Professor |
| Affiliation |
Department Of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jaipur |
| Address |
Department Of Anaesthesia
Sawai Man Singh Medical College
and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
09928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Meena |
| Designation |
Resident doctor |
| Affiliation |
Department Of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jaipur |
| Address |
Department Of Anaesthesia
Sawai Man Singh Medical College
and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
07609066293 |
| Fax |
|
| Email |
meenakshi1.meena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia
Sawai Man Singh Medical College
and attached hospitals
Jaipur Rajasthan 302004 |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jaipur |
| Address |
Department Of Anaesthesia
Sawai Man Singh Medical College
and attached hospitals
Jaipur Rajasthan 302004 India |
| Type of Sponsor |
Government medical college |
|
|
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 Shriphal Meena |
Sawai Man Singh Medical College and attached hospitals Jaipur |
Department Of Anaesthesia
Sawai Man Singh Medical college Jaipur Rajasthan 302004
Jaipur
RAJASTHAN |
09928350391
dr.shriphal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee sms medical College and attached hospitals jaipur |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing elective lower limb and lower abdominal surgery.
2. Patients consenting to participate.
3. Adult patients aged 18-75 Years.
4. Patients belonging to American Society of Anesthesiologists (ASA) grade I and II.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Mean duration of Anesthesia.
• Mean duration of Surgery.
|
Just after giving spinal Anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Time taken to give SAB:
• Time of Starting of Surgery:
• Time of end of Surgery:
• Duration of Surgery:
|
1.0 Min
2.2 Min
3.5 Min
4.10 Min
5.15 Min
6.20 Min
7.30 Min |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
01/04/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aims to assess the difficulty of administering spinal anesthesia based on two key factors : 1.Spinous process anatomy- the structure and alignment of the spinous processes can affect the ease of needle insertion. 2.Body Mass Index(BMI)- higher BMI is often associated with increased difficulty in locating anatomical landmarks for spinal anesthesia. The research will be conducted on patients undergoing lower limb and lower abdominal surgeries at SMS Medical College,Jaipur.The findings could help anesthesiologists predict challenging spinal anesthesia cases in advance,improving patient safety and procedural success. |