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
|
|
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
|
|
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
|
|
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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