| CTRI Number |
CTRI/2017/11/010545 [Registered on: 17/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to test the advantages of ultrasound guided spinal anesthsia as compared to conventional landmark using spinal anesthesia |
|
Scientific Title of Study
|
A study to test the efficacy and safety of pre-procedure ultrasound guided paramedian technique as compared to conventional landmark guided median technique in administering spinal anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brig Sunny Eapen |
| Designation |
Associate Professor, |
| Affiliation |
Armed forces medical college |
| Address |
Dept of Anaesthesiology and Critical care
AFMC
Solapur Road,Pune
411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9878732781 |
| Fax |
|
| Email |
sunny_eapen@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brig Sunny Eapen |
| Designation |
Associate Professor, |
| Affiliation |
armed forces medical college |
| Address |
Dept of Anaesthesiology and Critical care
AFMC
Solapur Road,Pune
411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9878732781 |
| Fax |
|
| Email |
sunny_eapen@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amresh Chandra Bal |
| Designation |
Resident Anesthesiology (Student) |
| Affiliation |
Armed forces medical college |
| Address |
Dept of Anaesthesiology and Critical care
AFMC
Solapur Road,Pune
411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9765169272 |
| Fax |
|
| Email |
drcool.amresh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology and Critical care
AFMC
Solapur Road,Pune
411040 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology and critical care
AFMC
Solapur Road ,Pune
411040 |
| 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 Brig Sunny Eapen |
Department of Anaesthesiology |
Departement of anaesthesiology and critical care
AFMC
sholapur road pune
411040
Pune
MAHARASHTRA |
9878732781
sunny_eapen@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell and Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients scheduled for elective surgeries under spinal anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
P group comprising ultrasound guided
C group comprising conventional landmark guided |
P group comprising preprocedure ultrasound guided paramedian approach for administering spinal anaesthesia in comparison to C Group comprising conventional landmark guided median approach for administering spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
age 50 years and above
consented patients scheduled for elective lower abdominal ,pelvic , lower limb surgeries |
|
| ExclusionCriteria |
| Details |
below 50 yrs
contraindication to spinal anesthesiaallergy to local anesthetic
coagulopathy
local site infection
indeterminate neurologic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total number of needle insertion attempts
Total number of needle passes |
0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of radicular pain,paresthesia
Incidence of blood in spinal needle |
0 |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
05/12/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study to compare safety and efficacy of pre-procedure ultrasound guided paramedian technique as compared to landmark guided median technique for administering spinal anesthesia |