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CTRI Number  CTRI/2025/01/079126 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 18/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Dexamethasone as an Adjuvant to Levobupivacaine for analgesic efficacy in Infraclavicular Brachial Plexus Block in patients undergoing Upper Limb Surgery 
Scientific Title of Study   Study of Dexamethasone as an Adjuvant to Levobupivacaine for Analgesic efficacy in Infraclavicular Brachial Plexus Block in patients undergoing Upper Limb Surgery 
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 Sarvjeet Kaur 
Designation  Professor and Head 
Affiliation  GGSMCH, Faridkot 
Address  Department of Anaesthesia, GGSMCH, Faridkot, Punjab, India, 151203

Faridkot
PUNJAB
151203
India 
Phone  9915680508  
Fax    
Email  drsarvjeetk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarvjeet Kaur 
Designation  Professor and Head 
Affiliation  GGSMCH, Faridkot 
Address  Department of Anaesthesia, GGSMCH, Faridkot, Punjab, India, 151203

Faridkot
PUNJAB
151203
India 
Phone  9915680508  
Fax    
Email  drsarvjeetk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarvjeet Kaur 
Designation  Professor and Head 
Affiliation  GGSMCH, Faridkot 
Address  Department of Anaesthesia, GGSMCH, Faridkot, Punjab, India, 151203

Faridkot
PUNJAB
151203
India 
Phone  9915680508  
Fax    
Email  drsarvjeetk@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, GGSMCH, Faridkot, Punjab, India, 151203 
 
Primary Sponsor  
Name  Dr Sarvjeet Kaur 
Address  Department of Anaesthesia, GGSMCH, Faridkot, Punjab 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mukesh Kumar  Department of Anaesthesia, GGSMCH, Faridkot, Punjab 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Faheem P  Guru Gobind Singh Medical College and Hospital  Department of Anaesthesia, GGSMCH, Faridkot, Punjab, India, 151203
Faridkot
PUNJAB 		 9531957808

faheemp196@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee ofGGSMCH Faridkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: X92-Y09||Assault, (3) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Perineural Levobupivacaine  To evaluate the duration of analgesia with perineural Levobupivacaine in Infraclavicular Brachial Plexus Block for upper limb surgeries 
Intervention  Perineural Levobupivacaine with Dexamethasone  To evaluate the duration of analgesia with perineural Levobupivacaine with Dexamethasone in Infraclavicular Brachial Plexus Block for upper limb surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with American Society of Anaesthesiologists grade I and II
2. Patients between age of 18-60 years, giving valid informed and written consent 
 
ExclusionCriteria 
Details  1. Patients with inability to comprehense pain
2. Patients who have allergy to study drugs
3. Patients with local site infections
4. Patients having coagulation abnormalities
5. Patients who are on prolonged analgesics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of sensory and motor Block  Every 1 hr till it resolves 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of analgesia  Every 1 hr till it resolves 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   05/02/2025 
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="1"
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
Modification(s)  		 We aim to evaluate the role of perineural dexamethasone as an adjuvant along with levobupivacaine in infraclavicular brachial plexus block for upper limb surgeries. The study will be conducted in a randomized, controlled manner in the Department of Anaesthesiology, GGS Medical College and Hospital, Faridkot on patients of age between 18 to 60 years, American Society of Anaesthesiologists Grade I and II, scheduled to undergo below elbow surgeries. The total patients 60 will be randomly allocated into groups of 30 patients each.
Group LB:-will receive 25 ml drug (24 ml 0.5% levobupivacaine + 1 ml NS)
Group LD:- will receive 25 ml drug (24ml 0.5% levobupivacaine plus 1 ml dexamethasone(4mg)
 
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