FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/11/010327 [Registered on: 01/11/2017] Trial Registered Retrospectively
Last Modified On: 01/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Injection of local anaesthetic with or without adjuvant in neck under sonography guidance in order to anaesthetise forearm and hand 
Scientific Title of Study   Comparison of plain Ropivacaine versus Ropivacaine with different concentration of Dexmedetomidine in ultrasound guided supraclavicular block for Orthopedic forearm surgery-A prospective , randomised , comparative clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit P Chauhan 
Designation  Assistant Professor 
Affiliation  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Department of Anaesthesiology PIMSR OT Complex po.Limda Waghodia
Post Limda Vadodara Waghodia Gujarat 391760
Vadodara
GUJARAT
391760
India 
Phone  9426368170  
Fax    
Email  dramitchauhan8885@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit P Chauhan 
Designation  Assistant Professor 
Affiliation  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Department of Anaesthesiology PIMSR OT Complex po.Limda Waghodia
Post Limda Vadodara Waghodia Gujarat 391760
Vadodara
GUJARAT
391760
India 
Phone  9426368170  
Fax    
Email  dramitchauhan8885@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit P Chauhan 
Designation  Assistant Professor 
Affiliation  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Department of Anaesthesiology PIMSR OT Complex po.Limda Waghodia
Post Limda Vadodara Waghodia Gujarat 391760
Vadodara
GUJARAT
391760
India 
Phone  9426368170  
Fax    
Email  dramitchauhan8885@gmail.com  
 
Source of Monetary or Material Support  
Parul Sevashram Hospital po Limda Waghodia Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Parul sevashram hospital 
Address  P.O Linda,Tal: Waghodia, District: Vadodara.Pincode:391760 
Type of Sponsor  Research institution and hospital 
 
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 Amit P Chuahan  Parul Sevashram hospital  Department of Anaesthesiology PIMSR OT Complex po.Limda Waghodia
Vadodara
GUJARAT 		 9426368170

dramitchauhan8885@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PU-IECHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Upper limb fractures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Supraclavicular brachial plexus block  1.plain ropivacaine vs 2.plain ropivacaine with 50mic dexmedetomidine vs 3.plain ropivacaine with 100mic dexmedetomidine 
Intervention  Supraclavicular brachial plexus block  Supraclavicular block with 1.plain ropivacaine vs 2.plain ropivacaine with 50mic dexmedetomidine vs 3.plain ropivacaine with 100mic dexmedetomidine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA grade 1 and 2
2.Both elective and emergengy surgeries.
3.Upper limb surgeries-elbow,forearm and hand
4.Patient able to give informed and written consent 
 
ExclusionCriteria 
Details  1.Allergy or hypersensitivity to local anaesthtic agent
2. Patient with bleeding disorder or on anticoagulant therapy
3. Pregnant patient
4. Patient with major cardiovascular,respiratory ,renal,and liver disease
5. Patient taking opiod medicine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Duration of analgesia
2. Duration of sensory and motor block 		 1. From end of surgery to pain on VAS OF 4 or more..
2. From onset of block to start of recovery 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects, sedation score, rescue analgesic  Every 2 hourly upto 24 hrs 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   16/08/2017 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Supraclavicular block of brachial plexus is commonly used block for Orthopedic forearm surgery. Ropivacaine is local anaesthetic agent that block peripheral afferents acting on voltage gated sodium channel. It provide good operative condition but have shorter duration of postoperative analgesia and good cardiovascular safety. Hence various adjuvants were added to local anaesthetic in brachial plexus block to achieve quick, dense and prolonged block. Dexmedetomedine, an alpha2 agonist is an adjuvant to local anaesthetic in regional anaesthesia to enhance quality and duration of analgesia. Dose range of 0.5 - 2microgm/kg has been used in various studies. The aim of study is to enhance safety and efficacy of plain Ropivacaine with different concentrations of dexmedetomedine. 
Close