| CTRI Number |
CTRI/2023/06/053515 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Identifying point of sciatic nerve division in popliteal fossa using ultrasound |
|
Scientific Title of Study
|
Anatomical variation of sciatic nerve bifurcation in popliteal fossa- Ultrasonographic assessment in Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnendu S |
| Designation |
Fellow In Regional Anesthesia |
| Affiliation |
Ganga hospital |
| Address |
Ganga hospital,Mettupalayam road,saibaba kovil,coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7353191783 |
| Fax |
|
| Email |
krishnendushiva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin Kumar Goel |
| Designation |
Junior Consultant |
| Affiliation |
Ganga hospital |
| Address |
Ganga hospital,Mettupalayam road,saibaba kovil,coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9443369715 |
| Fax |
|
| Email |
drvipingoel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Kumar Goel |
| Designation |
Junior Consultant |
| Affiliation |
Ganga hospital |
| Address |
Ganga hospital,Mettupalayam road,saibaba kovil,coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9443369715 |
| Fax |
|
| Email |
drvipingoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga hospital, Mettupalayam road, Saibaba kovil , Coimbatore- 641043, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Vipin Kumar Goel |
Ganga hospital |
Department of Anesthesia,Ganga hospital,Mettupalayam road,saibaba kovil,coimbatore
Coimbatore
TAMIL NADU |
9443369715
drvipingoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ganga Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers with ASA I and II
BMI of 18.5 to 30 |
|
| ExclusionCriteria |
| Details |
Pregnancy
Limb deformity
History of trauma to the site of scanning
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the distance of sciatic nerve bifurcation from popliteal crease |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the depth of sciatic nerve at its bifurcation |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "255"
Final Enrollment numbers achieved (India)="255" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2023 |
| Date of Study Completion (India) |
05/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sciatic nerve block has been used for various surgeries and maintenance of analgesia below the knee. Our aim of this study is to assess the level of bifurcation of sciatic nerve from popliteal crease and depth of bifurcation among Indian population using ultrasound guidance. This will help us to establish a reference point in our population which will be helpful while performing landmark guided sciatic nerve block. |