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CTRI Number  CTRI/2025/07/090962 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARING HOW WELL ULTRASOUND GUIDED INFRACLAVICULAR BLOCK WORK OVER SUPRACLAVICULAR BLOCK FOR SURGERIES ON THE UPPERLIMB 
Scientific Title of Study   EFFECTIVENS OF ULTRASONOGRAPHY GUIDED SUPRCLAVICULAR BLOCK VERSUS INFRACLAVICULAR BLOCK FOR UPPERLIMB SURGERIES 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  D Venkata Naga Sai Krishna Sanka 
Designation  Junior Resident 
Affiliation  DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH] 
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India 
Phone  09963371113  
Fax    
Email  sanka.dileep3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sudha Jain 
Designation  Professor 
Affiliation  DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH] 
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India 
Phone  9850361863  
Fax    
Email  sudhajain1258@gmail.com  
 
Details of Contact Person
Public Query  
Name  D Venkata Naga Sai Krishna Sanka 
Designation  Junior Resident 
Affiliation  DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH] 
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India 
Phone  09963371113  
Fax    
Email  sanka.dileep3@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College  
Address  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India 
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 
D Venkata Naga Sai Krishna Sanka  Jawaharlal Nehru Medical College  Department of Anaesthesiology Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA 		 09963371113

sanka.dileep3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH]  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 
Intervention  usg guided infraclavicular block  A linear probe is placed just below the clavicle inferior Place the ultrasound probe in the infraclavicular fossa, just below the clavicle. It should be oriented transversely to visualize the subclavian artery and the brachial plexus cords. A 22 gauge, 80 mm block needle is used during block performance.Insert the needle at a 30-45° angle to the skin, aiming toward the brachial plexus. The needle should be inserted from a lateral approach, lateral to medial, directed toward the brachial plexus. Keep the needle in the plane of the ultrasound probe so you can visualize its movement throughout the procedure. with duration of 30minutes 
Comparator Agent  usg guided supraclavicular block  Patient position,Place the patient in a supine position with their head turned to the opposite side, and the arm to be blocked abducted at 90°. Operator position,Stand at the patients head or side, depending on your comfort and the location of the ultrasound machine using ultrasound machine with a high-frequency linear transducer (10-15 MHz) is preferred for superficial structures. A 22-gauge short bevel needle is commonly used for the block.Place the ultrasound probe transversely just above the clavicle, in the supraclavicular fossa. This allows visualization of the brachial plexus. You should see the subclavian artery, brachial plexus, and the first rib. The brachial plexus will appear as a cluster of hypoechoic (dark) structures adjacent to the artery. The first rib is usually hyperechoic (bright) and lies inferior to the plexus.Under direct ultrasound guidance, insert the needle in-plane (parallel to the ultrasound probe) to ensure accurate visualization of the needle tip as it approaches the brachial plexus. The needle should be advanced carefully toward the brachial plexus, aiming for the space lateral to the subclavian artery. With duration of 30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.patient undergoing elective upperlimb surgeries.
2.ASA gradung I,II & III.
3.patient willing to participate in study. 
 
ExclusionCriteria 
Details  1.patient refusal.
2.allergy to lpcal anaesthectics and opioids.
3.local infection at the site of block.
4.pregnant women.
5.severe cardiopulmonary disease.
6.patients with neurological deficit in operating arm.
7.bleeding disorders or patients on anticoagulants.
8.geriatric age group and cognitive impaired patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
intraoperative observation in both groups I and S based on ,
1.onset of block
2.duration of block
3.requirement of rescue analgesia time

hemodynamics monitoring  		 till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
side effects ,
1.hematoma
2.bleeding
3.pneumothorax
4.druga allergy
5.others

post operative observation on basis of,
1.pain grade
2.sedation
3.respiratory inadequecy 		 observed till 6 hours after surgery 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Phase 2 
Date of First Enrollment (India)   01/08/2025 
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="0"
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   infra clavicular approach gives faster onset , better surgical effectivenss and fewer adverse events compared to supracavicular approach for brachil plexus block under ultra sound guidence using regional anaesthesia . dividing into 2 groups infraclaviculaat (I) and supraclaviculat (S), taking 21 patients minimum in each group .the assessment of intraoperative observation of onset of block , duration of block adn requirement of rescue analgesia  with hemodynamicall monitoring also luking for any side effects like hematoma , bleeding, pneumothorax, drug allergy and others . assessment of postoperative events like pain grade , sedation and respiratory inadequecy upto 6 hours after surgery. 
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