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CTRI Number  CTRI/2025/03/082493 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two doses of dexamethasone in addition to Levobupivacaine in Supraclavicular Brachial Plexus Block for Upper limb Orthopaedic Surgeries 
Scientific Title of Study   Comparing Variable Doses Of Dexamethasone As An Adjuvant To Levobupivacaine In Ultrasound Guided Supraclavicular Brachial Plexus Block For Patients Undergoing Orthopaedic Upper Limb Surgeries – A Prospective Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Ashwin Suuraj V  
Designation  Senior Resident 
Affiliation  Ortho-One Orthopaedic Speciality Centre 
Address  Department of Anaesthesiology OT Complex 3rd Floor Ortho-One Orthopaedic Speciality Centre 657 & 658 Trichy road , Singanallur , Coimbatore

Coimbatore
TAMIL NADU
641005
India 
Phone  8754026064  
Fax    
Email  ashwinsuuraj55@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Ashwin Suuraj V  
Designation  Senior Resident 
Affiliation  Ortho-One Orthopaedic Speciality Centre 
Address  Department of Anaesthesiology OT Complex, 3rd Floor , Ortho-One Orthopaedic Speciality Centre , 657 & 658 , Trichy Road , Singanallur , Coimbatore

Coimbatore
TAMIL NADU
641005
India 
Phone  8754026064  
Fax    
Email  ashwinsuuraj55@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Ashwin Suuraj V  
Designation  Senior Resident 
Affiliation  Ortho-One Orthopaedic Speciality Centre 
Address  Department of Anaesthesiology OT Complex, 3rd Floor , Ortho-One Orthopaedic Speciality Centre 657 & 658 ,Trichy Road , Singanallur , Coimbatore

Coimbatore
TAMIL NADU
641005
India 
Phone  8754026064  
Fax    
Email  ashwinsuuraj55@gmail.com  
 
Source of Monetary or Material Support  
Ortho-One Orthopaedic Speciality Centre 657 & 658 , Trichy Road , Singanallur , Coimbatore , Tamil Nadu , India - 641005 
 
Primary Sponsor  
Name  OrthoOne Orthopaedic Speciality Centre 
Address  Ortho-One Orthopaedic Speciality Centre 657 & 658 Trichy Road Singanallur Coimbatore 641005 
Type of Sponsor  Private hospital/clinic 
 
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 
Ashwin Suuraj  Ortho-One Orthopaedic Speciality Centre  Ortho-One Orthopaedic Speciality Centre 657 & 658 Trichy Road Singanallur Coimbatore - 641005
Coimbatore
TAMIL NADU 
8754026064

ashwinsuuraj55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE ORTHO-ONE ORTHOPAEDIC SPECIALITY CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Dexamethasone  Inj. Levobupivacaine 0.25 % 20 ml + Inj . Dexamethasone 4 mg diluted to 2 ml with NS = 22 ml. 
Comparator Agent  Inj. Dexamethasone  Inj. Levobupivacaine 0.25 % 20 ml + Inj . Dexamethasone 6 mg diluted to 2 ml with NS = 22 ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Elective and Emergency Orthopaedic Upper limb surgeries
ASA I , II and III 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of analgesia between 4 mg of dexamethasone and 6 mg of dexamethasone
added to levobupivacaine 
0 hours , 2 hours , 4 hours , 8 hours , 12 hours , 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time taken for onset of sensory & motor block  0 mins , 2 mins , 4 mins , 6 mins , 8 mins , 10 mins , 12 mins , 14 mins , 15 mins 
To assess the total requirement of rescue analgesia over a period of 24 hours post-
operatively 
0 hours - 24 hours 
To assess the Intensity of pain , Haemodynamic status of patients over 24 hours  0 hours to 24 hours 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   02/04/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Supraclavicular Brachial Plexus block is a good alternative to general anaesthesia for upper

limb orthopaedic surgeries. This avoids the untoward effects of general anaesthetic drugs and

upper airway instrumentation in patients.

It achieves muscle relaxation, intraoperative hemodynamic stability and post-operative analgesia and reduces the requirement of post-operative opioid usage.

Considering the pharmacological profile of Bupivacaine, its clinical efficacy, long duration of action and favourable ratio of sensory to motor block it is used most frequently among local anaesthetics for brachial plexus block. However its major disadvantage is cardiotoxicity, primarily triggered by its dextrogyrous enantiomer

Levobupivacaine, a pure S- enantiomer of Bupivacaine has potentially reduced toxic profile compared to Bupivacaine. Levobupivacaine is a better drug for regional block due to its low cardiotoxic profile compared to Bupivacaine. Levobupivacaine’s efficacy proved similar or greater than Bupivacaine in regional blocks and could be used more safely in ASA grade 3 and 4 patients and cardiac patients in whom general anaesthesia is risky.

Peripheral nerve blocks with local anaesthetics provide excellent operating conditions,

facilitate early mobilisation and bypass the post anaesthesia care unit, but duration of

analgesia is rarely maintained for more than 4-8 hours even with the longest acting local

anaesthetics.

Perineural catheters can improve duration of analgesia from local anaesthetics but carry

problems of catheter migration, pump malfunction, leakage, etc.

Therefore, many adjuvants are added to the local anaesthetic in single shot regional

technique with variable results. Different drugs have been used as adjuvants with local

anaesthetics in brachial plexus block to achieve a quick, dense and prolonged block.

Various studies have shown that addition of corticosteroid dexamethasone, as a non

particulate injection, to local anaesthetics prolongs duration of blockade by approximately

8-10 hours in peripheral nerves.

However, the administration of dexamethasone is not risk free and concerns have been raised

regarding hyperglycaemia and surgical site infection. These adverse effects are likely to be

dose dependent. Owing to the potential toxicity concern, it may be beneficial to use lower

doses of dexamethasone, if these provide similar increase in analgesia duration compared to

higher doses

The purpose of this study is to compare the effectiveness, duration and quality of motor

blockade and sensory blockade between patients receiving of two relatively low doses (4 mg

and 6 mg) of dexamethasone, used as adjuvant to 0.25% levobupivacaine, for supraclavicular

brachial plexus block in patients undergoing upper limb orthopaedic surgeries




 
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