| CTRI Number |
CTRI/2020/10/028276 [Registered on: 07/10/2020] Trial Registered Prospectively |
| Last Modified On: |
06/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find the relation between a persons physical parameters (Eg: Weight, Height, BMI) and the distance measures from skin surface to spine |
|
Scientific Title of Study
|
Association between skin to sub arachnoid space depth and anthropometric parameters |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreekumar M R |
| Designation |
PG Resident |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesia,
Pushpagiri Institute of Medical Sciences and Research Centre, Thiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
9497321606 |
| Fax |
|
| Email |
drsreekumar1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathews K Thomas |
| Designation |
Associate Professor |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesia,
Pushpagiri Institute of Medical Sciences and Research Centre, Thiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
7356879388 |
| Fax |
|
| Email |
mathewskthomas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mathews K Thomas |
| Designation |
Associate Professor |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesia,
Pushpagiri Institute of Medical Sciences and Research Centre, Thiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
7356879388 |
| Fax |
|
| Email |
mathewskthomas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri Institute of Medical Sciences and Research Centre, Thiruvalla, Kerala-689101 |
|
|
Primary Sponsor
|
| Name |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Pushpagiri Institute of Medical Sciences and Research Centre, Thiruvalla, Kerala-689101 |
| Type of Sponsor |
Private 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 Sreekumar M R |
Pushpagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesia
Pathanamthitta
KERALA |
9497321606
drsreekumar1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pushpagiri Institute of Medical Sciences and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: N40-N53||Diseases of male genital organs, (3) ICD-10 Condition: V00-Y99||External causes of morbidity, (4) ICD-10 Condition: K40-K46||Hernia, (5) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing Sub Arachnoid regional block
American Society of Anaesthesiologists Grade I and II |
|
| ExclusionCriteria |
| Details |
Pregnancy
Emergency surgeries
Patients having infection at site of injection and allergies to any drugs used for the procedure |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Age
Sex
Weight
Height
Wrist Inter styloid Distance
Skin to Sub Arachnoid Space Depth (SSD) |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age
Sex |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
09/10/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional observation study to find the association of skin to sub arachnoid space depth and anthropometric parameters in adult patients undergoing sub arachnoid regional block that will be conducted in a single centre in India. The primary outcome measurements are age, height, weight, sex, wrist inter styloid distance and skin to sub arachnoid space depth. |