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CTRI Number  CTRI/2019/01/017187 [Registered on: 22/01/2019] Trial Registered Prospectively
Last Modified On: 20/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational 
Study Design  Single Arm Study 
Public Title of Study   Predicting the success of ultrasound guided anaesthesia to upper limb using an perfusion index  
Scientific Title of Study   Predicting the success of ultrasound guided supraclavicular brachial plexus block using pulse oximeter perfusion index  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hashim Rahman A 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesia Kasturba Medical College and Hospital Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9597910578  
Fax    
Email  hashimrahman91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr lokvendra Singh budania 
Designation  Associate professor 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesia Kasturba Medical College and Hospital Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9901628947  
Fax    
Email  drbudania@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hashim Rahman A 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesia Kasturba Medical College and Hospital Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9597910578  
Fax    
Email  hashimrahman91@gmail.com  
 
Source of Monetary or Material Support  
kasturba hospital 
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital 
Address  Department of Anaesthesia Kasturba Medical College and Hospital Manipal Udupi 
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 
HASHIM RAHMAN A  KASTURBA MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY KASTURBA HOSPITAL MANIPAL UDUPI
Udupi
KARNATAKA 		 9597910578

hashimrahman91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I
Age group- 18 to 65
Patients posted for upper limb surgeries
 
 
ExclusionCriteria 
Details 
Patient refusal
Infection over the site of needle insertion
History of allergy to local anaesthetics
Bleeding disorder
ASA physical status 2 and above
Patient on beta blockers
Active infection at site of injection
Diabeties/vascular disease
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the perfusion index (PI) and PI ratio as predictors of successful supraclavicular brachial plexus block  From the time of giving block to 30mins after the block is been given 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the trend of PI once peripheral nerve block has been administered

To determine best cut off value of PI for detection of block efficacy

To determine the correlation between the PI values and the degree of block (assessing the sensory and motor blockade)

 		 From the time of giving block to 30mins after the block is been given 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   22/01/2019 
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   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Supraclavicular brachial plexus block is a popular approach for anaesthesia for upper limb surgeries. Traditional methods to evaluate the adequacy of the block is based on assessment of sensory and motor response to stimuli. This method is subjective, time consuming and depends on patient cooperation. Various objective methods for evaluation of a successful block have been described and one among them is the quantitative evaluation of blockade of the autonomic innervation to arm. Physiological changes such as vasodilation and changes in blood flow and skin temperature are used to assess the success of block. However, these signs do not appear fast enough to be used for clinical decision making particularly for confirming the adequacy of block before or during surgery. Perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow and is a measure for the level of vascular dilation. It is measured by a special pulse oximeter (Masimo SET pulse oximeter). This PI is automatically calculated by the pulse oximeter and provides an indication for peripheral perfusion at sensor site (finger). Perfusion index monitoring may provide a highly valuable tool to quickly evaluate the success of supraclavicular brachial plexus block.

Aims: To determine whether the perfusion index(PI) which is a measure of peripheral perfusion measured using a pulse oximeter,  can be used to predict and provide a cut off value for a successful ultrasound guided supraclavicular brachial plexus block administered for upper limb surgeries

Objectives:

Primary objective

To determine the perfusion index (PI) and PI ratio as predictors of successful supraclavicular brachial plexus block


 

Secondary objectives

1)To determine the trend of PI once peripheral nerve block has been administered

 

2)To determine best cut off value of PI for detection of block efficacy

 

3)To determine the correlation between the PI values and the degree of block (assessing the sensory and motor blockade)


Patients will be seen on the day prior to surgery and will be assessed for suitability of inclusion in study. Written informed consent will be taken. Standard guidelines for 

fasting will be followed. Any medication being taken by the patient will be continued or discontinued according to the standard guidelines. On the day of surgery, the 

patients will be shifted to the preoperative holding area of operation theatre. After confirming their NPO status, standard monitors with noninvasive blood pressure, pulse 

oximeter (Masimo SET pulse oximetry) and five lead electrocardiogram will be connected. An intravenous access is obtained in the non-operative upper limb.

Baseline perfusion index values will be recorded in both hands using Masimo SET pulse oximeter. Under strict aseptic precaution the supraclavicular nerve block will be 

performed under USG guidance using the supraclavicular approach. The block will be given with patient in semi recumbent position with head turned away from site to be 

blocked. A 22 gauge insulated block needle will be inserted in plane to USG probe. A volume of 30 ml of local anaesthetic (15ml of 0.5% bupivacaine and 15ml of 2% 

lignocaine with adrenaline) will be injected under vision around the plexus. The limb will be evaluated for block success every 5mins.Sensory function will be assessed 

using pinprick in dermatomal areas and motor block will be assessed by modified Bromage scale. Block will be considered successful when brachial plexus dermatomes 

(C5-T1) are completely blocked. The perfusion index will be measured every 5 mins by Masimo SET pulse oximeter applied on index finger from the time of injection of 

local anaesthetic, in both blocked and contralateral unblocked limb. The perfusion index will be measured for 30mins. The PI ratio is calculated as the ratio between the PI 

at 5mins and the base line PI. The average percentage change in PI from baseline at 5min interval from patients with successful nerve blocks and failed block will be 

calculated. After a minimum of 30 min, patients will be transferred to the operating room. The operating surgeon will assess the operative site for pain sensation using a 

surgical forceps. If patients report of pain at this time, the block will be described as “failed” and general anesthesia will be administered according to the decision of the 

anesthesiologist.

Outcome measures:  

            1. Percentage of change in PI value from baseline in blocked arm and unblocked arm in a successful block

            2. Percentage of change in PI value from baseline in blocked arm and unblocked arm in a failed block

            3. Cut off value of perfusion index in a successful block

 
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