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CTRI Number  CTRI/2024/08/072786 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   the participants posted for surgery under spinal anaesthesia will be intervened by ultrasonography before giving spinal anaesthesia and the outcome of the procedure will be compared to the conventional spinal anaesthesia technique 
Scientific Title of Study   A study to compare preprocedural ultrasound versus landmark technique for spinal anesthesia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumaiyya fatima 
Designation  Post graduate student 
Affiliation  Mahadevappa rampure medical college 
Address  Department of anaesthsiology, Basaveshwara teaching and general hospital attached to Mahadevappa rampure medical college, Kalaburagi karnataka.
Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka-585105.
Gulbarga
KARNATAKA
585105
India 
Phone    
Fax    
Email  sumaiyafatima68r@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lata D shetty 
Designation  Professor 
Affiliation  M.R. medical college gulbarga 
Address  Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka -585105.

Gulbarga
KARNATAKA
585105
India 
Phone  9731046446  
Fax    
Email  latads@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Lata D shetty 
Designation  Professor 
Affiliation  M.R. medical college gulbarga  
Address  Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka-585105.

Gulbarga
KARNATAKA
585105
India 
Phone  9731046446  
Fax    
Email  latads@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka-585105, India. 
 
Primary Sponsor  
Name  Department of Anaesthesiology, Basaveshwara teaching and general hospital 
Address  Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College Kalaburagi Sedam Rd, Rajapur, Kalaburagi, Karnataka 585105 
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 Lata D Shetty  Basaveshwara Hospital   Department of anaesthesia, 1st floor major operation theatre.
Gulbarga
KARNATAKA 
9731046446

latads@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee M.R. Medical college, kalaburagi  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 
Comparator Agent  landmark technique   use of landmark technique to establish spinal anaesthesia 
Intervention  Use of ultrasonography for spinal anaesthesia  Use of ultrasonography compared with landmark technique for spinal anaesthesia administration till successful spinal anaesthesia is established. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists grade I and II patients.
2. Patients of all genders between the ages of 18-60 years.
3. Patients undergoing elective surgeries under spinal anaesthesia. 
 
ExclusionCriteria 
Details  1. Patients with history of allergy to drugs used in the study.
2. Pregnant and lactating patients.
3. Patients with any infection at the site of injection and spine deformity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
successful spinal anaesthesia in Preprocedural Ultrasound (US) group and landmark technique group.  during spinal anaesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
The number of needle puncture attempt and duration taken to establish
successful spinal anaesthesia in Preprocedural Ultrasound (US) group and Landmark Technique (LM) group.  
during spinal anaesthesia  
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   30/08/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The ideal technique for spinal anaesthesia requires successful dural puncture with single spinal needle pass. Spinal anaesthesia is traditionally performed by palpation of bony landmarks to identify the level of needle insertion using the intercristal line as a guide for identifying L4 (4th lumbar vertebrae) or L4-5 space, but in females and patients with higher body mass indices the level may vary to L3 (3rd lumbar vertebrae) or L3-4 space, causing difficulty to predict the level Frequent attempts during lumbar puncture causes cerebrospinal fluid leakage which is associated with increased incidence of Post Dural Puncture Headache (PDPH). Studies have shown that pre-procedural ultrasound facilitates first attempt success rate in elderly patients, hence use of ultrasonography (USG) will decrease the number of attempts and incidence of PDPH by increasing the first attempt success rate. Recently ultrasound imaging has become a popular tool among anaesthesiologists in operation theatres and intensive care units. USG is widely used in operation theatres for nerve blocks but has still taken a backseat when it comes to neuraxial blocks. USG during the neuraxial blocks usually increases procedural duration making the procedure more intricate. Many studies for USG guided paramedian approach are conducted whereas very few studies are done for routine USG guided midline approach, hence the present study “A STUDY TO COMPARE PREPROCEDURAL ULTRASOUND VERSUS LANDMARK TECHNIQUE FOR SPINAL ANESTHESIA’’ will be conducted to fill this lacune with the hypothesis that Preprocedural USG reduces the number of attempts, reduces the procedural time, reduces the number of needle punctures and PDPH in patients.

 
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