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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
 
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
 
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