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CTRI Number  CTRI/2020/07/026467 [Registered on: 10/07/2020] Trial Registered Prospectively
Last Modified On: 26/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To determine if addition of Dexmedtomidine to Bupivacaine used in Femoral Nerve Block will enhance duration of post operative analgesia 
Scientific Title of Study   Efficacy of Dexmedetomidine as an adjuvant to 0.25% Bupivacaine in Ultrasound guided Femoral Nerve Block for Pre-operative positioning and Post-operative Analgesia in patients undergoing elective surgery for Femoral shaft fracture 
Trial Acronym  FNB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinod M 
Designation  Junior Resident 
Affiliation  Vijayanagara Institute of Medical Sciences, Ballari 
Address  Dept of Anaesthesiology and Critical Care, Vijayanagara Institute of Medical Sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9902375272  
Fax    
Email  vinodm9092@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devanand B 
Designation  Professor and HOD  
Affiliation  Vijayanagara Institute of Medical Sciences, Ballari 
Address  Dept of Anaesthesiology and Critical Care, Vijayanagara Institute of Medical Sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9845233239  
Fax    
Email  dr.devanand.b@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinod M 
Designation  Junior Resident 
Affiliation  Vijayanagara Institute of Medical Sciences, Ballari 
Address  Dept of Anaesthesiology and Critical Care, Vijayanagara Institute of Medical Sciences, Cantonment, Ballari


KARNATAKA
583104
India 
Phone  9902375272  
Fax    
Email  vinodm9092@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Vijayanagara Institute of Medical Sciences 
Address  Cantonment, Ballari - 583104 
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 Vinod M  Vijayanagara Institute of Medical Sciences  Major OT Complex, VIMS Hospital Cantonment, Bellary - 583104
Bellary
KARNATAKA 		 9902375272

vinodm9092@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijayanagara Institute of Medical Sciences Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S723||Fracture of shaft of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine  Dexmedetomidine 2mcg/kg (2cc) as an adjuvant to Bupivacaine 0.25% (20cc) in ultrasound guided femoral nerve block 
Intervention  Femoral Nerve Block  Femoral Nerve Block for providing comfort of positioning for subarachnoid block and provide Post operative analgesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA Grade I & II 
 
ExclusionCriteria 
Details  1 Allergy to Study Drug
2 History of significant systemic disease ( n
Cardiovascular, Respiratory, Central Nervous
System, Renal System )
3 Cognitive Dysfunction
4 Emergency Surgeries
5 Patients with Spinal Deformities, Bleeding
Diasthesis
6 Local Skin Site Infection
7 Refusal by patients for procedure 
 
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 determine patient comfort for positioning for spinal anaesthesia and Duration of post operative analgesia  From start of procedure until 24 hrs post operative 
 
Secondary Outcome  
Outcome  TimePoints 
1 Onset, Duration, Level of sensory Block
2 Onset, Duration of motor Block
3 Side effects like Hypotension, Bradycardia, Respiratory Depression etc. 		 From start of procedure until 24 hrs postoperative 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "700"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/07/2020 
Date of Study Completion (India) 09/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary             Femoral Nerve Block,(FNB) a type of regional anaesthesia provides for reduction in pain intensity in the Peri-operative period allowing for easy positioningand extending analgesia postoperatively, thereby reducing the need for opioids.
Various adjuvant drugs such as epinephrine, opioids, Sodium Bicarbonate, midazolam, ketamine, and neostigmine have been evaluated in conjunction with local anesthetics to prolong the duration of analgesia, but they were found to be either ineffective or to produce an unacceptably high incidence of adverse effects.

         Dexmedetomidine is a selective α2 adrenoceptor agonist has an Analgesic, Anaesthetic sparing effect, Symphatholytic, Sedative, Cardiovascular stabilizing property. Not many studies have been performed using it as an adjuvant to femoral nerve block, hence a study to know its effectiveness as an adjuvant is being planned.
 
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