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CTRI Number  CTRI/2023/07/055402 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 22/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   Comparing dexmedetomidine and dexamethasone for upper limb surgeries under block anaesthesia  
Scientific Title of Study   Dexmedetomidine versus dexamethasone as adjuvant to local anaesthetic in brachial plexus block 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjana Muraleedharan  
Designation  Junior resident  
Affiliation  K.S Hegde medical accademy 
Address  Department of anaesthsiology and critical care K.s Hegde medical academy Mangalore ,karnataka
Nandhanam, behind GHSS school, koduvayur, palakkad
Dakshina Kannada
KARNATAKA
575018
India 
Phone  8157892438  
Fax    
Email  anjanamuraleedhran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Shetty  
Designation  Professor, Department of Anaesthesiology and critical care 
Affiliation  K.S Hegde medical accademy 
Address  Department of anaesthesiology and critical care K.S Hegde medical academy Dakshina kannada Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448012303  
Fax    
Email  shetty.anil10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjana Muraleedharan  
Designation  Junior resident, department of anaesthsiology and critical care 
Affiliation  K.S Hegde medical accademy  
Address  Department of anaesthesiology and critical care K.S Hegde medical academy Dakshina kannada Karnataka
Nandhanam, behind GHSS school, koduvayur, palakkad
Dakshina Kannada
KARNATAKA
575 018
India 
Phone  8157892438  
Fax    
Email  anjanamuraleedhran@gmail.com  
 
Source of Monetary or Material Support  
K S hegde medical accademy Dept of anaesthesiology and critical care 
 
Primary Sponsor  
Name  Anjana Muraleedharan  
Address  Junior resident, department of anaesthesiology and critical care K.S Hegde medical accademy Mangalore, karnataka  
Type of Sponsor  Other [SELF] 
 
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 
Anjana Muraleedharan   K S Hegde medical accademy   Department of anaesthsiology and critical care K S Hegde medical accademy Derlakatte Mangalore,karnataka, 575018
Dakshina Kannada
KARNATAKA 
8157892438

anjanamuraleedhran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, K S hegde medical accademy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  20 to 60 years of age
ASA ps status 1,2, 3
Posted for elective and emergency surgeries of elbow,forearm,wrist and hand  
 
ExclusionCriteria 
Details  Block failure and resultant recourse to other modalities of anaesthesia
Patients with change in surgical plan 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare dexmedetomidine & Dexamethasone
The onset of sensory & motor blockade
The duration of sensory & motor blockade

 
Onset- every 2 minutes for sensory and motor
Duration- 24 hrs
 
 
Secondary Outcome  
Outcome  TimePoints 
The total duration of analgesia
Quality of the block

 
It is defined as the time interval between administration of drug & the first rescue analgesia
QUALITY OF BLOCK: This will be assessed by the attending Anaesthesiologist as excellent, good,moderate or uncessful  
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   27/07/2023 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Brachial plexus block (BPB) is one of the most commonly used anaesthetic techniques for upper limb surgeries. It can be done through various approaches, namely- supraclavicular, infraclavicular, interscalene, axillary, cervical and paravertebral. The narrowest part of the brachial plexus is located in the supraclavicular region and anaesthesia will be rapid, dense and predictable for the entire upper limb. USG guidance helps in the deposition of drug at the apt place, augments block success and avoids problems associated with conventional techniques like discomfort, nerve injury and high failure rates. Addition of adjuvants to local anaesthetics shortens the onset of sensory and motor block and prolongs the duration of block
Dexmedetomidine is a d-isomer of medetomidine. It is a highly selective alpha-2 agonist, with 8 times more affinity than clonidine.3 Dexmedetomidine acts by presynaptic activation of alpha-2 receptors, thereby terminating pain signal by inhibiting noradrenaline release
Dexamethasone is a synthetic corticosteroid, that is preferred due to its high anti-inflammatory properties. It is 25-30 times more potent than hydrocortisone with no mineralocorticoid activity.
Steroid addition can prolong duration of block and produce earlier onset.The anti-inflammatory property due to inhibition of phospholipase A2 is responsible for the analgesic effect.
 Primary objectives:
To compare dexmedetomidine and Dexamethasone as adjuvant to local anaesthetics in USG guided supraclavicular brachial plexus block in terms of:
• The onset of sensory and motor blockade
• The duration of sensory and motor blockade
Secondary objectives:
To compare dexmedetomidine and dexamethasone as adjuvant to local anaesthetics in USG guided supraclavicular brachial plexus block in terms of:
• The total duration of analgesia
• Quality of the block
 After approval from the Institutional Ethics Committee, participants satisfying the inclusion criteria will be enrolled after obtaining written informed consent.
 A pre-anaesthetic evaluation will be done a day prior to the surgery for elective surgeries.
Patients will be shifted to the operation theatre. All the basal parameters will be recorded.
USG guided supraclavicular Brachial plexus block will be administered to the patient by the consultant anaesthesiologist in-charge of the case and the blinded observer will acquire the data for the next 24 hours thereafter the patient will be grouped as per the combination of the drugs used.
Supraclavicular brachial plexus block will be performed under all aseptic precautions using ultrasound equipped with a high frequency (6-13 MHz) linear probe. With the patient lying supine and head turned 45° contralateral, the site will be prepared and draped. Ultrasound transducer will be placed in the supraclavicular fossa in the coronal oblique plane to visualize brachial plexus in the transverse sectional view. Brachial plexus will be approached with a 25 G needle. The block needle will be inserted using the in-plane technique, from lateral-to-medial direction towards the brachial plexus and the study drug will be injected incrementally following negative aspiration to obtain a uniform spread around the brachial plexus.
 The following data will be collected in the intraoperative and the postoperative period:-
DURATION OF ONSET OF SENSORY BLOCKADE: It is assessed along the dermatomal distribution of four nerves – musculocutaneous, median, ulnar and radial nerves using the ‘spirit swab method’.
 The onset of sensory is defined as the time interval between the LA administration and the achievement of complete loss of sensation along the dermatomal distribution of all four nerves 
 DURATION OF SENSORY BLOCKADE: It is defined as the time interval between end of drug administration and complete resolution of anaesthesia in the dermatomal distribution of all 4 nerves (patient response score of 0)
DURATION OF ONSET OF MOTOR BLOCKADE: It is assessed using the ‘modified Bromage scale for upper limb’
SCORE RESPONSE
 The onset of motor block is defined as the time interval between the LA administration and the achievement of complete loss of motor function (until Modified Bromage Scale score of 0).
DURATION OF MOTOR BLOCKADE: It is defined as the time interval between end of drug administration and complete resolution of motor function (until Modified Bromage Scale score of 4).
Secondary objectives:
To compare dexmedetomidine and dexamethasone as adjuvant to local anaesthetics in USG guided supraclavicular brachial plexus block in terms of:
• The total duration of analgesia
• Quality of the block
 DURATION OF ANALGESIA: It is defined as the time interval between administration of drug and the first rescue analgesia.
RESCUE ANALGESIA: When the post op NRS score reaches 4, rescue analgesic Tramadol injection 50 mg IV will be given. The post operative pain assessment will be stopped once the rescue analgesic is given.
QUALITY OF BLOCK: This will be assessed by the attending Anaesthesiologist as excellent,good , moderate or unsuccessful 
 
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