| CTRI Number |
CTRI/2024/04/065214 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of correlation between hip/shoulder width ratio and sensory level of subarachnoid block in adult patients- A prospective observational study |
|
Scientific Title of Study
|
Evaluation of correlation between hip/shoulder width ratio and sensory level of subarachnoid block in adult patients- A prospective observational 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 Mamata Bhardwaj |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Dept of Anaesthesia, PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamata Bhardwaj |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Dept of Anaesthesia, PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamata Bhardwaj |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Dept of Anaesthesia, PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
N/A |
| Type of Sponsor |
Other [N/A] |
|
|
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 |
| Anuj Tripathi |
PGIMS Rohtak |
Pt. BD Sharma PGIMS Rohtak Haryana 124001
Rohtak
HARYANA |
8910367266
dr.anuj1607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee Pt. B. D. Sharma post graduate institute of medical sciences, UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
undergoing any surgery under spinal anaesthesia with no contraindication for Lumbar puncture |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of anaesthesiologists (ASA) physical status I and II
2. weight from 50 kg to 100 kg
3. height 150 cm to 175 cm |
|
| ExclusionCriteria |
| Details |
Patients having:
1. contraindication to spinal anaesthesia(coagulopathy, infection at the puncture site, anticoagulant medications and lack of consent for spinal anaesthesia)
2. vertebral column abnormalities or with a prior history of spine surgery
3. allergy to local anaesthetics, and pregnancy will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| n/a |
n/a |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| n/a |
n/a |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/05/2024 |
| 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="2"
Months="0"
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
|
n/a |