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CTRI Number  CTRI/2024/11/077007 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effectiveness of two different volumes of Ropivacaine in a block for post operative pain relief in upper limb orthopaedic surgeries 
Scientific Title of Study   Comparison of Ultrasound Guided Interscalene Brachial Plexus Block with 6ml and 10ml of 0.25 percent Ropivacaine for post operative analgesia in elective upper limb orthopaedic surgeries: A Randomised Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gayatri Awatade 
Designation  Junior Resident 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9168285999  
Fax    
Email  gayatriawatade98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali Bhure 
Designation  Professor and HOD, Department of Anaesthesiology 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9822563121  
Fax    
Email  anjali_bhure@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Gayatri Awatade 
Designation  Junior Resident 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9168285999  
Fax    
Email  gayatriawatade98@gmail.com  
 
Source of Monetary or Material Support  
N.K.P Salve Institute of Medical Sciences and Research centre and Lata Mangeshkar Hospita, Digdoh Hills, Hingna, Nagpur - 440019 Sciences and Research Centre and Lata Mangeshkar Hospital 
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Digdoh Hills Nagpur 440019 
Type of Sponsor  Private 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 
Gayatri Awatade  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.
Nagpur
MAHARASHTRA 		 9168285999

gayatriawatade98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur.  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  Ultrasound Guided Interscalene Brachial Plexus Block  Injection Ropivacaine 0.25% 10ml Postoperatively before extubation. Time of completion of injection of local anaesthetic will be labelled as 0 minutes. Patient will be observed for 24 hours 
Intervention  Ultrasound Guided Interscalene Brachial Plexus Block  Injection Ropivacaine 0.25% 6ml Postoperatively before extubation. Time of completion of injection of local anaesthetic will be labelled as 0 minutes. Patient will be observed for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients posted for upper limb orthopaedic surgeries
2.Patients in ASA criteria 1,2
3.Patients with BMI less than 30 kg/m2 
 
ExclusionCriteria 
Details  1. History of allergy to study drug
2. Patient with coagulation disorders
3. Infection at site of block
4. Severe bronchopulmonary disease
5. Neurological deficit in the operating arm
6. Patient not willing to participate 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare post operative analgesia between 6 ml of 0.25% Ropivacaine
vs 10 ml of 0.25% Ropivacaine in ultrasound (USG) guided Interscalene
brachial plexus block for Elective Upper Limb Orthopedic surgeries 		 1. Total analgesic dose required in 24 hours after block.
2. Numerical rating scale (NRS) for pain assessment at 0.5, 1, 1.5, 2, 4, 6, 12, 24 hrs after block in first 24 hours.
3. Time for requirement for first rescue analgesia after block in first 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare side effects of 0.25 percent Ropivacaine 6 ml & 0.25 percent
Ropivacaine 10 ml in Ultrasound guided Interscalene Block for Upper
limb Orthopaedic surgeries 		 1.Incidence of Hemi diaphragmatic paresis at 0.5 & 1 hrs after block
2.Hemodynamic stability at 0.5 & 1 hrs after block
3.Post operative Nausea & Vomiting Upto 24 hrs after block
All to be assessed for first 24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) 30/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
 In the field of Anaesthesia, regional blocks are growing popular these
days because of prolonged duration of action and lesser perioperative
analgesic requirement.
• Interscalene brachial plexus block is frequently used to provide
perioperative analgesia to patients undergoing upper limb surgeries to
optimise recovery, decrease opioid consumption and reduce the
hospital stay.
• Ropivacaine is a long-acting amide local anaesthetic agent that is
structurally related to Bupivacaine.
• It is a pure S(-)enantiomer, unlike Bupivacaine, which is a racemate,
developed for the purpose of reducing potential toxicity and improving
relative sensory and motor block profiles .
• Ropivacaine in interscalene brachial plexus block provides safe and
effective pain relief , decreased incidence of side effects and better
patient satisfaction than with opioids given intravenously.
• The use of a local anaesthetic with a lower concentration and volume
results in fewer instances of side effects brought on by local anaesthetic
drugs.
• Furthermore, use of ultrasound in peripheral nerve block has reduced
the amount of Local Anaesthetic.
• Studies have been found with 0.5% or 0.75% of 15ml Ropivacaine used
for peripheral blocks which provide same analgesia with less side effects
of Ropivacaine .
• Interscalene brachial plexus block is generally performed on patients
undergoing shoulder, upper arm and elbow surgeries .
• One of the side effects of this block is Hemidiaphragmatic paresis.
• Studies were found where small volume of local anaesthetic for
interscalene brachial plexus block helped in reducing the incidence of
hemidiaphragmatic paresis.
• Therefore, our aim is to compare 6ml and 10ml of 0.25% Ropivacaine in
ultrasound guided interscalene block in upper limb surgeries with
respect to postoperative analgesia and side effects like
hemidiaphragmatic paresis.
 
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