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CTRI Number  CTRI/2019/04/018608 [Registered on: 15/04/2019] Trial Registered Prospectively
Last Modified On: 10/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Levobupivacaine and Ropivacaine in Patients Undergoing Forearm Orthopaedic Surgeries under Brachial Plexus Block 
Scientific Title of Study   A Prospective Randomized Study to compare Levobupivacaine and Ropivacaine in Patients Undergoing Forearm Orthopaedic Surgeries under Ultra Sound Guided Supraclavicular Brachial Plexus Block 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Razi Shahid 
Designation  Postgraduate Resident  
Affiliation  Teerthanker Mahaveer Medical College & Research Center 
Address  Department of Anaesthesiology, Teerthanker Mahaveer University N.H. 24, Delhi Road, Bagadpur, Moradabad, Uttar Pradesh 244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  9335959296  
Fax    
Email  razishahid7866@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Kumar Prasad 
Designation  Associate Professor  
Affiliation  Teerthanker Mahaveer Medical College & Research Center 
Address  Department of Anaesthesiology, Teerthanker Mahaveer University N.H. 24, Delhi Road, Bagadpur, Moradabad, Uttar Pradesh 244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  9837624543  
Fax    
Email  mukeshkumar2002@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gurdeep Singh Jheetay  
Designation  Professor and Head of the Department of Anaesthesiology  
Affiliation  Teerthanker Mahaveer Medical College & Research Center 
Address  Department of Anaesthesiology, Teerthanker Mahaveer University N.H. 24, Delhi Road, Bagadpur, Moradabad, Uttar Pradesh 244001

Moradabad
UTTAR PRADESH
244001
India 
Phone    
Fax    
Email  drgurdeep.medical@tmu.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Teerthanker Mahaveer Medical College and Research Center , Teerthanker Mahaveer University, N.H. 24, Delhi Road, Bagadpur, Moradabad, Uttar Pradesh 244001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Department of Anaesthesiology   Teerthanker Mahaveer Medical College and Research Center , Teerthanker Mahaveer University, N.H. 24, Delhi Road, Bagadpur, Moradabad, Uttar Pradesh 244001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Razi Shahid  Teerthanker Mahaveer Medical college and research center  Orthopedics Operation Theater Room number 3 and 4, Department of Anaesthesiology, Hospital Building Teerthanker Mahaveer Medical Hospital.
Moradabad
UTTAR PRADESH 
9335959296

razishahid7866@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER MORADABAD INSTITUTIONAL ETHICS COMMITTEE(TMMC-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) grade I & II patients
Age group 18- 60 years
Patients with BMI 18.5-22.9 kg/m2
Elective cases 
 
ExclusionCriteria 
Details  Infection at the end site of injection
Neuromuscular disorder
Patients with pre-existing diseases, cardiovascular or cerebrovascular diseases,
Severely altered mental status.
Patient converted to general anesthesia intra-operatively. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Study the effects of Levobupivacaine versus Ropivacaine in patients undergoing forearm orthopedic surgeries under ultra sound guided supraclavicular brachial plexus block.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Sensory block, Motor block , Haemodynamic parameters, and side effects.  18 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/05/2019 
Date of Study Completion (India) 13/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 13/03/2020 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
[1] Shantanu B, Kulkarni, Pimpare M, Balasaheb T, Govardhane. Comparison of levobupivacaine with Ropivacaine for supraclavicular brachial plexus block.Int J Res Med Sci. 2016;4:3789-96. [2] Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014;8:202–08.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
A Prospective Randomized Study to compare Levobupivacaine and Ropivacaine in Patients Undergoing Forearm Orthopaedic Surgeries under Ultra Sound Guided Supraclavicular Brachial Plexus Block.
The patients will be randomly divided into two groups using “chit and box” method.
a) Group I (L): Patient proposed to undergo upper limb surgery under Supraclavicular brachial plexus block using 30ml of 0.5% Levobupivacaine.
b) Group II (R): Patients proposed to undergo upper limb surgery under Supraclavicular  brachial plexus block using 30ml of 0.5% Ropivacaine.
The patients will be placed in a supine position, with the head turned away and the ipsilateral arm adducted. Skin will be prepared with 10% povidone-iodine solution. All the patients will receive ultra sound(Sono site M-Turbo, Sono site , Inc., Bothwell , MO,USA)guided probe(frequency 10-15 MHz, covered with a sterile dressing)  to sub fascial intracluster supraclavicular brachial plexus block which was performed by  the anesthesiologist.
The needle will be removed and firm digital pressure with gauze piece will be held at the site for 5min to assist in proximal spread of the anesthetic solution.
Sensory and motor block will be evaluated preoperatively to determine a baseline and every 5 min for 30 min or until onset of blockade will be noted and thereafter every 60 min. Sensory block will be assessed by the pinprick method (22G hypodermic needle).Hemodynamic parameters and vitals (Blood pressure, Heart rate, Respiratory rate and Oxygen saturation) will be also monitored during the procedure.
REFRENCES:
[1] Shantanu B, Kulkarni, Pimpare M, Balasaheb T, Govardhane. Comparison of levobupivacaine with Ropivacaine for supraclavicular brachial plexus block.Int J Res Med Sci. 2016;4:3789-96.
[2] Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014;8:202–08.

 
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