CTRI Number |
CTRI/2023/10/058970 [Registered on: 20/10/2023] Trial Registered Prospectively |
Last Modified On: |
17/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A comparison of USG guided versus Conventional technique of subarachnoid block in obese patients |
Scientific Title of Study
|
Pre-procedural Ultrasound scanning for subarachnoid block versus Landmark guided subarachnoid block in Obese patients:A Prospective randomised controlled 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 |
Nayani Nimisha Laxmanbhai |
Designation |
Resident Doctor |
Affiliation |
Government medical college ,Vadodara |
Address |
Department of aneasthesiology , SSG Hospital , Government medical college ,Vadodara
Vadodara GUJARAT 390001 India |
Phone |
7621908377 |
Fax |
|
Email |
nimishanayani@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kavita Lalchandani |
Designation |
Associate Professor |
Affiliation |
Government medical college, Vadodara |
Address |
Department of Aneasthesiology, SSG Hospital,Government medical college, Vadodara
Vadodara GUJARAT 390001 India |
Phone |
9274586809 |
Fax |
|
Email |
lalchandanikavita@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Nimisha Nayani |
Designation |
Resident Doctor |
Affiliation |
Government medical college, vadodara |
Address |
Department of Aneasthesiology, SSG Hospital, Government medical college, Vadodara
Vadodara GUJARAT 390001 India |
Phone |
7621908377 |
Fax |
|
Email |
nimishanayani@gmail.com |
|
Source of Monetary or Material Support
|
Department of Aneasthesiology, 2 nd floor OT Block , SSG Hospital, Vadodara |
|
Primary Sponsor
|
Name |
Government medical college, vadodara |
Address |
Department of Aneasthesiology, SSG Hospital ,Government medical college , vadodara |
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 |
Nimisha Nayani |
SSG Hospital , Vadodara |
Operation theatre, new surgical block, SSG Hospital ,Vadodara Vadodara GUJARAT |
7621908377
nimishanayani@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee for Biomedical and Health Research(IECBHR) Medical College, SSG Hospital , Baroda |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Landmark guided subarachnoid block |
Conventinal Landmark guided technique will be used for subarachnoid block. |
Intervention |
Ultrasound scanning for subarachnoid block |
Pre- procedural ultrasound scanning will be done to identify inter vertebral space for subarachnoid block. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1)Basal metabolic index -30 to 40kg/m2
2)ASA Grade- II AND III |
|
ExclusionCriteria |
Details |
1)Patient refusal
2)Contraindication to central neauraxial block
3)Patient with local site infection
4)Patient with coagulopathy disorder
5)Pregnant female
6)Patient with elevated intra cranial pressure |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To Compare number of attempts for subarachnoid block |
1 |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)No. of needle passes
2) Time for identifying intervertebral space
3) Time taken for subarachnoid block
4) Time to achieve successful block
|
1)1
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
16/07/2024 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
17/08/2023 |
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)
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
|
This study is a randomised controlled trial comparing efficacy of preprocedural ultrasound scanning in obese patients for reducing the number of attempt for subarachnoid block . After pre aneasthestic evaluation and 6 -8 hours of fasting , informed written consent will be taken from the patient .Then patient will be taken inside operation theatre , multipara monitors will be attached and all baseline vital parameters will be recorded .Premedication and Adequate pre loading will be done. Patient will be kept in sitting position on a level table with feet resting on foot rest with an assistant holding the patient.
Grouping of patient : The study population will be randomly devided in two groups
GROUP P: Pre -procedural ultrasound scanning group In this group low frequency curvilinear probe will be placed vertically in paramedian plane to visualise sacrum which appeared as linear hyperechoic line with acoustic shadow anteriorly, now probe will be slide cranially to first visualise L5-S1 Interlaminarspace then L5-L4 and L3-L4 interlaminar space these space will be marked using surgical marker pen . Now the probe will be rotated 90 degree and placed transversly in midlineto visualise spinous process which appeared as linear hypoechoic shadow, now the central point of probe will be marked and this point will be extended as a vertical line using surgical marking pen. The point where these two line intersect will be our point of indertion of spinal needle.now under all aseptic precaution subarachnoid block will be given in marked point of insertion using 23 G Spinal needle. GROUP L: Landmark guided Group In this group conventional landmark guided technique will be used to identify the intervertebral space. under all sterile aseptic precaution subarachnoid block will be given with 23 G Spinal needle.
Followimg parameter will be recorded in both the group: 1) Number of attempts 2) Number of needle passes 3) Time taken to identify the intervertebral space 4) Time taken for subarachnoid block 5) Time to achieve successful block |