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CTRI Number  CTRI/2024/01/061026 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 09/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare how long pain relief lasts between plain bupivacaine and bupivacaine with dexamethasone 
Scientific Title of Study   Efficacy of different doses of epidural dexamethasone with bupivacaine versus plain bupivacaine for post operative analgesia in patients undergoing abdominal and lower limb surgeries 
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 Santhosh M C B 
Designation  Associate professor 
Affiliation  Mandya Institute of Medical Sciences 
Address  Department of Anesthesiology Mandya Institute of Medical Sciences Mandya

Mandya
KARNATAKA
571401
India 
Phone  7892877646  
Fax    
Email  mcbsanthu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santhosh M C B 
Designation  Associate professor 
Affiliation  Mandya Institute of Medical Sciences 
Address  Department of Anesthesiology Mandya Institute of Medical Sciences Mandya

Mandya
KARNATAKA
571401
India 
Phone  7892877646  
Fax    
Email  mcbsanthu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santhosh M C B 
Designation  Associate professor 
Affiliation  Mandya Institute of Medical Sciences 
Address  Department of Anesthesiology Mandya Institute of Medical Sciences Mandya

Mandya
KARNATAKA
571401
India 
Phone  7892877646  
Fax    
Email  mcbsanthu@gmail.com  
 
Source of Monetary or Material Support  
Mandya Institute of Medical Sciences Mandya 571401 
 
Primary Sponsor  
Name  Dr Santhosh M C B 
Address  Associate professor Department of Anesthesiology Mandya Institute of Medical Sciences Mandya 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Akshay C  Post graduate student Mandya institute of medical sciences mandya 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshay C  Mandya Institute of Medical Sciences  Department of Anesthesiology Mandya Institute of Medical Sciences Mandya
Mandya
KARNATAKA 		 9886778009

akshaychandra97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee, MIMS, Mandya  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 
Intervention  Epidural analgesia with bupivacaine plus dexamethasone  Epidural analgesia given with either bupivacaine plus 4mg dexona or bupivacaine plus 8mg dexona once visual analog score is more than or equal to 3 after 1st dose with plain bupivacaine and analgesia is measured in next 24 hours with the help of visual analog score. 
Comparator Agent  Epidural analgesia with plain bupivacaine  Epidural analgesia given with 10ml of 0.1% bupivacaine once the visual analog score of patients is more than or equal to 3 in post operative period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of both sexes aged more than or equal to 18 years
Patients undergoing abdominal and lower limb surgeries
American society of anaesthesiologists grade I and II
Patients who are willing to participate in the study with informed consent 
 
ExclusionCriteria 
Details  Anaphylaxis to the study drug dexamethasone and bupivacaine
Patients with opioid drug intake for other co morbid conditions
Patients on any other routine analgesics for other conditions
Body mass index of more than or equal to 25kg/sq.m
Patients who are known diabetics
Any complications during insertion of epidural catheter
Any intra operative or post operative complications 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare duration of post operative analgesia between two different doses of dexamethasone as adjuvant versus plain bupivacaine among patients undergoing abdominal and lower limb surgeries  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare adverse events between the groups for 24 hours after giving epiduraL top-up  24 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   01/02/2024 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study we are evaluating duration of post operative analgesia provided by epidural bupivacaine with either 4mg dexamethasone or 8mg dexamethasone in comparison to plain bupivacaine alone among patients undergoing abdominal and lower limb surgeries. 
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