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CTRI Number  CTRI/2025/09/094211 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Dexamethasone and Clonidine added to local anaesthetic for pain relief in upper limb surgery using ultrasound-guided nerve block 
Scientific Title of Study   Randomized double-blind controlled trial comparing the analgesic effect of Dexamethasone versus Clonidine as adjuvants to 0.5% Levobupivacaine in ultrasound-guided supraclavicular brachial plexus block in patients undergoing upper limb surgery at SMS Medical College, Jaipur.”  
Trial Acronym  DEX-CLO LEVO 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Payal Mittal 
Designation  Postgraduate Resident 
Affiliation  Department of Anaesthesiology and Critical Care, SMS Medical College & Attached Hospitals, Jaipur 
Address  138 gurunanakpura rajapark

Jaipur
RAJASTHAN
302007
India 
Phone  8740881453  
Fax    
Email  pihumittal888@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Khandelwal 
Designation  Senior Professor  
Affiliation  Department of Anaesthesiology and Critical Care, SMS Medical College & Attached Hospitals, Jaipur 
Address  Department of Anaesthesiology and Critical Care SMS Medical College & Attached Hospitals, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mamta Khandelwal 
Designation  Senior Professor  
Affiliation  drmamtakhandelwal@gmail.com 
Address  drmamtakhandelwal@gmail.com

Jaipur
RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, SMS Medical College & Attached Hospitals, Jaipur Rajasthan India pincode 302004 
 
Primary Sponsor  
Name  SMS Medical College Jaipur 
Address  Sawai Man Singh Medical College & Attached Hospitals, Jaipur, Rajasthan, India pincode 302004 
Type of Sponsor  Government 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 
Dr Payal Mittal  SMS Medical College & Attached Hospitals jaipur  Orthopaedics Operation Theatre, Department of Anaesthesiology and Critical Care
Jaipur
RAJASTHAN 		 8740881453

pihumittal888@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,SMS Medical College,Jaipur  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  Levobupivacaine 0.5% (20 ml) + Clonidine 0.5 mcg/kg (volume adjusted with saline upto 2 ml)  Levobupivacaine 0.5% (20 ml) with Clonidine 0.5 mcg/kg, administered as single-shot ultrasound-guided supraclavicular brachial plexus block 
Intervention  Levobupivacaine 0.5% (20 ml) + Dexamethasone 8 mg (2 ml)  Levobupivacaine 0.5% (20 ml) with Dexamethasone 8 mg (2 ml), administered as single-shot ultrasound-guided supraclavicular brachial plexus block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I or II
Weight 50–80 kg
Patients undergoing upper limb surgery under supraclavicular block
Written informed consent provided 
 
ExclusionCriteria 
Details  Allergy to study drugs (local anesthetic, dexamethasone, clonidine)
Coagulopathy or anticoagulant therapy
Local infection at injection site
Psychiatric illness or anxiety
Respiratory illness/compromise
Peripheral neuropathy or suspected compartment syndrome
Participation in another trial 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia: Time from block administration to first rescue analgesia (minutes)  Continuously monitored postoperatively; recorded up to 24 hours after block 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of sensory block  Time Point: Assessed at 0, 2, 5, 10, 15, 20, and 30 minutes after block administration 
Duration of sensory block  Monitored until regression; recorded up to 24 hours postoperatively 
Onset of motor block  Assessed at 0, 10, 20, and 30 minutes after block administration 
Duration of motor block  Monitored until regression; recorded up to 24 hours postoperatively 
Adverse effects  Intraoperative and up to 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 4 
Date of First Enrollment (India)   01/11/2025 
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   A prospective randomized double blind clinical study to compare the analgesic and anesthetic efficacy of Dexamethasone versus Clonidine as adjuvents to 0.5% Levobupivacain in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgery. Primary outcome is total dural of analgesia, with secondary outcomes  including onset/duration of sensory and motor block,hemodynamic changes and adverse events. 
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