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CTRI Number  CTRI/2023/06/053434 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 01/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   The distance to spinal space using three modalities of measurement  
Scientific Title of Study   Comparison of the depth of Subarachnoid space using anthropometric measurements, ultrasonographic measurements and actual depth by needle insertion in a patients with BMI more than 25kg/m2 
Trial Acronym  SAUN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSahil Mengaji 
Designation  MD Anesthesia  
Affiliation  KMC Hospital Mangalore 
Address  5th floor Department of Anesthesiology KMC hospital,Attavar

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8951566563  
Fax    
Email  Sahil.kmcmlr2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Julie Misquith 
Designation  Assistant professor ,Department of Anesthesia  
Affiliation  KMC Hospital Mangalore 
Address  5th floor Department of Anesthesiology Kasturba Medical Hospital Attavar , Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9945598911  
Fax    
Email  Juliemisquith@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrSahil Mengaji 
Designation  Year 1 of Post graduate,Department of Anesthesia  
Affiliation  KMC Hospital Mangalore 
Address  5th floor Department of Anesthesiology Kasturba Medical College Hospital,Attavar

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8951566563  
Fax    
Email  Sahil.kmcmlr2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Mangalore Karnataka 575001 
 
Primary Sponsor  
Name  kasturba medical college 
Address  Kasturba Medical college hospital Attavar Mangalore 575001 
Type of Sponsor  Private 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 
Dr Sahil  Kasturba Medical College Hospital  Department of Anesthesiology OT complex ,5Th floor
Dakshina Kannada
KARNATAKA 
8951566563

sahilmengaji@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Kasturba Medical College Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  BMI more than 25kg/m2
ASA I II III and undergoing elective abdominal and lower limb surgery under spinal anesthesia. 
 
ExclusionCriteria 
Details  1. Patient not wiling to participate
2. Patients with history of spinal abnormalities
3. Patients with contraindications to regional block
4. Patients with prior complaints of low back pain
5. Patients who had previous spinal surgery
6. Patients with BMI less than 25kg/m2 and
7. Pregnant patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i. Anthropometric measurements using Bonodio’s formula to calculate SSD
ii. Ultrasonography measurement of SSD
iii. Actual depth by needle insertion for SSD
 
6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
i. Compare the methods
ii. The number of attempts to achieve successful spinal tap
 
6 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   15/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/06/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

: Multiple attempts during subarachnoid block can result in complications like post dural puncture headache, lower back pain and cause discomfort to the patient, apart from being time consuming. Although, anatomical knowledge and technical skills are important, presumed prearrangement of the skin to subarachnoid space depth (SSD) may lead to the correct placement of the spinal needle. This allows for less traumatic and fewer repetitive attempts for spinal anesthesia. The palpation of bony landmarks required to successfully perform lumbar punctures (LPs) can be masked in 33% of overweight patients and 68% of patients with obesity, due to overlying soft tissue and can lead to LP failure rate of 19%. In a patient, the SSD varies considerably at different levels of the spinal cord. It also varies from patient to patient at the same vertebral level as per age, sex and body mass index (BMI). 

The rationale behind doing this study is to assess which method is more accurate to determine the SSD so as to minimize repeated attempts for spinal anaesthesia especially in overweight patients.

 The study is going to assess the SSD in a population with BMI>25kg/m2 with anthropometric measurements, ultrasonography and actual depth by needle insertion.

 
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