| CTRI Number |
CTRI/2023/09/057538 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of relation between waist/shoulder width on the extent of loss of sensation after injecting medicine in the back in patients undergoing surgeries in lower part of body |
|
Scientific Title of Study
|
Evaluation of Effect of Hip/Shoulder Width Ratio on the Sensory Level of Spinal Anaesthesia in lateral position in patients undergoing infraumbilical surgeries – 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 Prerana Nirav Shah |
| Designation |
Professor |
| Affiliation |
Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09869117027 |
| Fax |
|
| Email |
pps@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhushan Yadaorao Liaber |
| Designation |
PG Student |
| Affiliation |
Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09960055162 |
| Fax |
|
| Email |
liaber123bhushan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhushan Yadaorao Liaber |
| Designation |
PG Student |
| Affiliation |
Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09960055162 |
| Fax |
|
| Email |
liaber123bhushan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College KEM Hospital Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India |
|
|
Primary Sponsor
|
| Name |
Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 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 Bhushan Yadaorao Liaber |
Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9960055162
liaber123bhushan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- IEC-III Relating to Biomedical and Health Research Seth G S Medical College and KEM Hospital Mumbai Maharashtra |
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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing infraumbilical surgeries under spinal anaesthesia Weight 40 kg to 110 kg Height 140 cm to 180 cm
|
|
| ExclusionCriteria |
| Details |
Refusal of consent Any pregnanacy Any abnormalities involving hip, shoulder and vertebral column Fractures of hip, shoulder Contraindication to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess/correlate the effect of hip – shoulder width ratio with spread of spinal anaesthesia |
Pre Anaesthesia
After Spinal anaesthesia every five minutes for the next 30 minutesanaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the maximum cephalad dermatome level achieved for a measured hip-shoulder (HSR) and vertebral column length (VCL) |
Pre Anaesthesia
After Spinal anaesthesia every five minutes for the next 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/09/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Spinal anaesthesia is the most frequently used method for infraumbilical surgeries in adults. However cephalad spread of spinal anaesthesia is associated with complications. Many factors have been tested in clinical practice to predict the spread of spinal anaesthesia. In the present study we aim to correlate between the hip-shoulder width ratio with spread of spinal anaesthesia. Patients height, weight, BP, pulse, oxygen saturation, hip width, shoulder width, hip-shoulder ratio, vertebral column length will be measured. Patient will be given 3ml of intrathecal inj.Bupivacaine heavy in left lateral position and spinal sensory level achieved will be noted. Maximum sensory level and number of segments blocked from the fifth sacral vertebra will be noted. Maximum cephalad dermatome level achieved for a measured hip-shoulder width ratio (HSR) and vertebral column length (VCL) will be noted |