| CTRI Number |
CTRI/2024/04/066179 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Does the hip to shoulder width ratio affect the level of sensory block in adult patients undergoing lower limb surgery under spinal anaesthesia ?
|
|
Scientific Title of Study
|
EFFECT OF HIP TO SHOULDER WIDTH RATIO ON THE LEVEL OF
SENSORY BLOCK IN ADULT PATIENTS UNDERGOING LOWER LIMB
SURGERY UNDER 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 |
Dr Rajasree R B |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care
VMMC and Safdarjung Hospital
Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7907492740 |
| Fax |
|
| Email |
rajasreerajendran03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Mullick |
| Designation |
professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care
VMMC and Safdarjung Hospital
Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Mullick |
| Designation |
professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care
VMMC and Safdarjung Hospital
Ansari Nagar East New Delhi
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
Ansari nagar East
New Delhi |
| 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 |
| Rajasree R B |
VMMC and safdarjung hospital |
Department of anesthesia and intensive care,
Ansari nagar East Delhi
110029
110029
New Delhi
DELHI |
7907492740
rajasreerajendran03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung hospital institutional ethics committee |
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, |
|
|
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 |
1.Patients undergoing elective lower limb surgeries in supine position under spinal anaesthesia.
2.Age 18 to 60 years, height 160 cm to 180 cm, weight 50 kg to 80 kg.
3.American Society of Anaesthesiologists(ASA) physical status I/II.
|
|
| ExclusionCriteria |
| Details |
1.Patients with spinal deformity, history of previous spine surgery or having any contraindication for spinal anaesthesia.
2.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between hip to shoulder width ratio and level of sensory block in adult patients undergoing lower limb surgery under spinal anaesthesia. |
0,2min,4min, 6min, 8min, 10min, 15min, 20min, 35min, 50min, 1hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation of height, weight, body mass index & vertebral column length with level of sensory block in adult patients undergoing lower limb surgery under spinal anaesthesia. |
0, 2min, 4min, 6min, 8min, 10min, 15min, 20min, 35min, 50min, 1hr |
|
|
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)
|
01/05/2024 |
| 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="1"
Months="6"
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
|
Anthropometric measures like hip width, shoulder width, hip to shoulder width ratio, weight, height, BMI will be measured preoperatively for patients undergoing lower limb surgeries and will be compared with the maximum level of sensory block achieved after spinal anaesthesia |