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CTRI Number  CTRI/2019/05/018918 [Registered on: 03/05/2019] Trial Registered Prospectively
Last Modified On: 01/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare lignocaine alone and in combination with dexmedetomidine for intravenous regional anaesthesia for upper limb surgery. 
Scientific Title of Study   A study to compare the anaesthetic properties of 0.5% alone and in combination with dexmedetomidine for intravenous regional anaesthesiain patients undergoing upper limb orthopaedicsurgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpi tada 
Designation  Postgraduate student 
Affiliation  Jln Medical College ajmer  
Address  Department of anaesthesiology jln medical college ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  8890026413  
Fax    
Email  drshilpitada@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neena jain 
Designation  Senior professor and guide  
Affiliation  Jln Medical College ajmer  
Address  Department of anaesthesiology jln medical college ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414008666  
Fax    
Email  drneenaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neena jain 
Designation  Senior professor and guide  
Affiliation  Jln Medical College ajmer  
Address  Department of anaesthesiology jln medical college ajmer


RAJASTHAN
305001
India 
Phone  9414008666  
Fax    
Email  drneenaj@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia, Jln Medical College ajmer , 305001 
 
Primary Sponsor  
Name  Jln Medical College ajmer  
Address  Department of anaesthesiology jln medical college ajmer  
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 Shilpi tada  Jln Medical College ajmer   Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN 		 8890026413

drshilpitada@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, JLN medical college   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 
Comparator Agent  0.5 % lignocaine alone and in combination with Dexmedetomidine  To reduce the dose of lignocaine and compare quality of anaesthesia and duration of analgesia 
Intervention  Intravenous regional anaesthesia  Onset of motor and sensory block  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age between 20 to 55 years, of either sex.
2.Body weight 35 to 80 kg.
3.Patients belonging to ASA Class I and II.
4. Patients undergoing upper limb surgeries of duration less than 45 minutes.
5.Patient free from any associated acute or chronic systemic illness. 
 
ExclusionCriteria 
Details  1. Patients with contraindications to tourniquet application like sickle cell anemia, cellulitis, sepsis, open wound in that extremity, etc.
2. Patients hypersensitive to lignocaine
3. Patient not willing for IVRA
4. Patient already on analgesics (opioids, NSAIDS)
5. Patients receiving beta blockers or cardiac drugs.
6. History of convulsion, allergy to the drug used, bleeding disorder, severe neurological deficit, thyroid disorder.
7. Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
8. Inadequate block necessitating institution of general anaesthesia for continuation of surgical procedure.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality and duration of post-operative analgesia  duration of study is around 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1.Torniquet pain.
2. Need for analgesic supplements
3. Post operative sedation
4. Adverse effects including nausea, vomiting, bradycardia, hypotension, desaturation and others, if any 		 Duration of study is around 1 year  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/05/2019 
Date of Study Completion (India) 21/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The aim of the study is “to compare anaesthetic properties of 0.5% lignocaine alone and in combination with Dexmedetomidine in intravenous  regionalanaesthesia in upper limb orthopaedic surgery”in the terms of:-

 

Objectives:

 

Primary:

1.Onset of sensory and motor block.

2. duration of  analgesia.

Secondary:

1.Duration of sensory and motor block.

2.Torniquet pain.

3.Need for analgesic supplements

4.Post operative sedation

5. Adverse effects including nausea, vomiting, bradycardia, hypotension, desaturation and others, if  any

 
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