| CTRI Number |
CTRI/2020/01/022917 [Registered on: 22/01/2020] Trial Registered Prospectively |
| Last Modified On: |
19/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Observational study to study the effect of anthropometric measurements and drug baricity on spinal aneasthesia |
|
Scientific Title of Study
|
Correlation between Hip/Shoulder Width Ratio and the Baricity on the spread of Spinal Anaesthesia in Lower abdominal surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VIJAYANAND S |
| Designation |
Professor |
| Affiliation |
Kempegowda Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kempegowda Institute Of Medical Sciences, Bangalore
KR Road, VV Puram, Bangalore, 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9341231411 |
| Fax |
|
| Email |
isasecretary15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umme Sarah |
| Designation |
Post Graduate |
| Affiliation |
KIMS,Bangalore |
| Address |
Department Of Anaesthesiology,
Kempegowda Institute Of Medical Sciences, Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9620626626 |
| Fax |
|
| Email |
sab_sarah91@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umme Sarah |
| Designation |
Post Graduate |
| Affiliation |
KIMS,Bangalore |
| Address |
Department Of Anaesthesiology,
Kempegowda Institute Of Medical Sciences, Bangalore
Koppal
KARNATAKA
560004
India |
| Phone |
9620626626 |
| Fax |
|
| Email |
sab_sarah91@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Umme Sarah
Kempegowda Institute of Medical Sciences, KR Road, VV Puram, Bangalore 560004 |
|
|
Primary Sponsor
|
| Name |
Dr Umme Sarah |
| Address |
Kempegowda Institute of Medical Sciences, KR Road, VV Puram, Bangalore 560004 |
| Type of Sponsor |
Other [Self] |
|
|
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 UMME SARAH |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
VV PURAM, BANGALORE 560004
Bangalore
KARNATAKA |
9620626626
sab_sarah91@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Studying effect of hip/ shoulder width ratio , and Baricity of two drugs- hyperbaric bupivacaine 0.5 % and isobaric ropivacaine 0.75% |
Hip shoulder width ratio will be measured in all patients,
Following which 3 ml of 0.5% hyperbaric bupivacaine in group 1 undergoing lower abdominal surgeries, and in group 2, Spinal Anaesthesia will be given wil 3 ml of 0.75% isobaric ropivacaine, Time taken to achieve the maximum level, and the total number of segments blocked are noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Weight 50-100 kgs
Height 140-180cms
Elective surgeries |
|
| ExclusionCriteria |
| Details |
Patients hat rejected the study or spinal anaesthesia
Contraindications for spinal Anaesthesia
Present severe Cardiovascular disease
Prior spine and spinal canal surgeries
ASA more than 2
Emergency surgeries
Patients shorter than 145 and taller than 180cms
Known Allergy to Local anesthetic agent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of baricity on the spread of drug, total level of spinal anaesthesia, time to reach maximum sensory blockade |
Pin prick test will be done in the mid clavicular line at 5mins, 10mins, 20 mins, 30 mins after the drug is deposited |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/01/2020 |
| 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="8"
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)?
|
|
Brief Summary
|
This study is intended to study of anthropometric measurements, like hip/shoulder width ratio on the spread of spinal anesthesia. In this study the baricity of drug(0.5% bupivacaine,0.75% ropivacaine) and its effect on the spread of spinal anesthesia will also be assessed. PIN PRICK test will be used to assess the extent of spread. Total level of spinal anaesthesia and time taken to achieve the maximal sensory blockade will be noted |