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CTRI Number  CTRI/2024/11/076853 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Assessment of oxygen level in blood for confirmation of successful block after giving infraclavicular block in patients undergoing upper limb surgery  
Scientific Title of Study   Assessment of perfusion index as a predictor of successful block following infraclavicular block in patients undergoing upper limb surgery  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Haramritpal Kaur 
Designation  Professor 
Affiliation  GGS Medical college and Hospital , Faridkot , Punjab 
Address  Department of Anaesthesia , GGS Medical college and hospital , Faridkot ,Punjab 151203 India

Faridkot
PUNJAB
151203
India 
Phone  9878088013  
Fax    
Email  amritk_dr@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Haramritpal Kaur 
Designation  Professor 
Affiliation  GGS Medical college and Hospital , Faridkot , Punjab 
Address  Department of Anaesthesia , GGS Medical college and hospital , Faridkot ,Punjab 151203 India

Faridkot
PUNJAB
151203
India 
Phone  9878088013  
Fax    
Email  amritk_dr@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Harlab Singh 
Designation  Junior Resident 
Affiliation  GGS Medical college and Hospital , Faridkot , Punjab 
Address  Department of Anaesthesia , GGS Medical college and hospital , Faridkot ,Punjab 151203 India

Faridkot
PUNJAB
151203
India 
Phone  9876585426  
Fax    
Email  Harlabsingh@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthisiology , GGS Medical college and Hospital , Faridkot , Punjab , India , Pincode 151203 
 
Primary Sponsor  
Name  Dr Haramritpal Kaur 
Address  Professor , Department of Anaesthesiology, GGS Medical College and Hospital, Faridkot , Punjab , India , Pincode 151203  
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 
Dr Harlab Singh  GGS medical college and Hospital , Faridkot  Department of Anesthesia , GGS Medical college and hospital , Faridkot ,Punjab 151203 India
Faridkot
PUNJAB 
09876585426

Harlabsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of GGS medical college and Hospital , Faridkot ,Punjab , India , Dr Haramritpal kaur and Dr Gagandeep (Mentioned in upper part of document) are the PI for the EC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V99||Unspecified transport accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists Grade I and II patients posted for elective upper limb surgeries under infraclavicular block. 
 
ExclusionCriteria 
Details  History of anaphylaxis or allergy to the study drugs and patients having hepatic, renal or cardiovascular dysfunction , skin or soft tissue infection at site of needle entry or having coagulopathy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study perfusion index as a predictor of successful infraclavicular block in patients undergoing upper limb surgeries  Perfusion Index will be assessed at baseline then every two minutes for ten minutes and every five minutes till thirty minutes following infraclavicular block. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare change in perfusion index in operative & non operative limb  Perfusion Index will be assessed at baseline then every two minutes for ten minutes & every five minutes till thirty minutes following infraclavicular block 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/12/2024 
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 Yet Recruiting 
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 infraclavicular block is a brachial plexus block used as an alternative or adjunct to general anesthesia. It can be used for postoperative pain control for upper extremity surgeries such as the elbow, forearm, and hand. The infraclavicular block is a regional anesthetic technique developed to avoid the side effects and complications of supraclavicular blocks, particularly pneumothorax.

The success of peripheral nerve blocks is usually assessed by sensory and motor function. But this method is subjective, time consuming and cannot be done in patients under deep sedation or otherwise unable to provide feedback. Various objective methods like thermographic temperature measurement, laser doppler perfusion imaging and skin electrical resistance have been developed. These methods depend on evaluation of sympathetic block and consequent physiological changes such as vasodilation, change in blood flow and skin temperature . However, most of these objective methods require sophisticated and expensive equipment.

Perfusion index (PI) is a simple, objective and non-invasive method for evaluation of the success of central neuraxial and peripheral nerve blocks. It has been shown to be useful measure to evaluate various peripheral nerve blocks. It is calculated by dividing the ratio of arterial blood flow (pulsatile) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and is shown as a percentage or absolute value. Perfusion index has been shown to help clinicians predict illness severity and early adverse respiratory outcomes in neonates, predict low superior vena cava flow in very low birth weight infants, provide an early indicator of sympathectomy after epidural anesthesia, and improve detection of critical congenital heart disease in newborn. As very few studies are available in literature for PI as an indicator for evaluating the success of peripheral nerve blocks. In present study we planned to evaluate the perfusion index as the predictor of successful block in patients undergoing upper limb surgeries under ultrasound guided infraclavicular block.

This study will include 60 patients of either sex planning to undergo upper limb surgeries under ultrasound-guided infraclavicular nerve block. After local anesthetic injection, sensory and motor block success will be assessed and perfusion index will be recorded at baseline and at every 2 minutes till 10 minutes and every 5 minutes thereafter till 30 min. The PI ratio will be calculated as the PI after 10 min divided by the PI at the baseline. The observation obtained will be tabulated and analyzed using appropriate statistical method.
 
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