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CTRI Number  CTRI/2026/03/105223 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the effect of dexamethasone added to bupivacaine for postoperative analgesia by the Transverse Abdominis Plane (TAP) block. 
Scientific Title of Study   To evaluate and compare the effects of different doses of dexamethasone added to bupivacaine on postoperative analgesia provided by the Transverse Abdominis Plane (TAP) block in patients undergoing lower abdominal 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  Pallavi mutreja 
Designation  Assistant professor 
Affiliation  World college of medical sciences and research hospital 
Address  Department of anaesthesia World college of medical sciences and research institute Girawar Haryana

Jhajjar
HARYANA
124103
India 
Phone  7982831058  
Fax    
Email  pallavimutreja51@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Preeti Dahiya 
Designation  Assistant professor 
Affiliation  World college of medical sciences and research hospital 
Address  Department of anaesthesia World college of medical sciences and research institute Girawar Haryana

Jhajjar
HARYANA
124103
India 
Phone  8375933406  
Fax    
Email  barbia29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Preeti Dahiya 
Designation  Assistant professor 
Affiliation  World medical college of medical sciences and research hospital 
Address  Department of anaesthesia World college of medical sciences and research hospital Girawar Jhajjar

Jhajjar
HARYANA
124103
India 
Phone  8375933406  
Fax    
Email  barbia29@ gmail.com  
 
Source of Monetary or Material Support  
World college of medical sciences and research hospital, Girawar , Jhajjar , Haryana , India 124103 
 
Primary Sponsor  
Name  Pallavi Mutreja 
Address  OT complex Department of anaesthesia World college of medical sciences and research institute Girawar Haryana 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Preeti Dahiya  Department of anaesthesia World college of medical sciences and research hospital Girawar Haryana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pallavi mutreja  World college of medical sciences and research hospital  OT complex 2nd floor Department of anaesthesia
Jhajjar
HARYANA 		 7982831058

Pallavimutreja51@ gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
World college of medical sciences and research  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  Bupivacaine(0.25%)  20 mL (0.25%) bupivacaine given as 10 mL on each side for bilateral TAP block 
Intervention  Dexamethasone 4mg   4mg dexamethasone added in (0.25%) bupivacaine to make a total volume of 20mL given as 10 mL on each side for bilateral TAP block.  
Intervention  Dexamethasone 8mg  8mg Dexamethasone added in (0.25%) bupivacaine to make a total volume of 20mL given as 10 mL on each side for bilateral TAP block.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I-II scheduled for elective lower abdominal surgeries 
 
ExclusionCriteria 
Details  ASA III and above with coagulopathy diabetes known allergic to local anesthetics and infection at the surgical site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesia among patients receiving TAP block with bupivacaine and varying doses of dexamethasone  Within 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To assess quality and efficacy of analgesia   Over 24 hrs 
To determine postoperative opioid consumption  24 hrs 
To monitor and assess blood sugar levels adverse effect  Every 4 hourly till 12 hr and then at 24 th hour 
 
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 4 
Date of First Enrollment (India)   12/03/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study is a prospective , randomised double blind study which will be conducted to assess and evaluate the efficacy of dexamethasone 4 mg and 8 mg  as adjuvant with bupivacaine in TAP block in 90  ASA I -II patients undergoing elective lower abdominal surgeries . The primary outcome will be the efficacy on postoperative analgesia over first 24 hrs post surgery . The secondary outcome measured will be to determine postoperative opioid consumption in 24 hrs and the adverse effect associated with dexamethasone use. 
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