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CTRI Number  CTRI/2025/02/080014 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 20/01/2026
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 pain relief of patients undergoing abdominal surgeries 
Scientific Title of Study   ANALGESIC EFFICACY OF INTRAVENOUS IBUPROFEN WITH TRAMADOL AND INTRAVENOUS PARACETAMOL WITH TRAMADOL FOR REDUCING POST OPERATIVE PAIN IN PATIENTS UNDERGOING LOWER ABDOMINAL SURGERIES FOLLOWING SUBARACHNOID BLOCK - A RANDOMISED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VARUN S 
Designation  Post Graduate  
Affiliation  Dept of Anaesthesiology  
Address  Dept of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences, Chinna Kolambakkam, Madhurantakam, Chengalpattu District
Karpaga Vinayaga Institute of Medical Sciences and Research centre
Kancheepuram
TAMIL NADU
603308
India 
Phone  7373166684  
Fax    
Email  varun.sambath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M. Murali Manoj 
Designation  Professor 
Affiliation  Karpaga Vinayaga Institute of Medical Sciences and Research Centre 
Address  Dept of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences, Chinna Kolambakkam, Madhurantakam, Chengalpattu District

Kancheepuram
TAMIL NADU
603308
India 
Phone  9791990979  
Fax    
Email  mmmslazenger@gmail.com  
 
Details of Contact Person
Public Query
 
Name  VARUN S 
Designation  Post Graduate  
Affiliation  Karpaga Vinayaga Institute of Medical Sciences and Research Centre 
Address  Dept of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences, Chinna Kolambakkam, Madhurantakam, Chengalpattu District

Kancheepuram
TAMIL NADU
603308
India 
Phone  7373166684  
Fax    
Email  varun.sambath@gmail.com  
 
Source of Monetary or Material Support  
Karpaga vinayaga institute of medical sciences and research centre, GST Road, Chinna kolambakkam Chengalpattu 603308 Tamilnadu India Cell: 9791990979 
 
Primary Sponsor  
Name  Varun S 
Address  Dept of Anaesthesiology, Karpaga vinayaga institute of medical sciences, GST Road Chinna Kolambakkam Chengalpattu Tamilnadu 603308 India Cell: 7373166684 
Type of Sponsor  Other [Self funding] 
 
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 Varun   Karpaga vinayaga Institute of Medical sciences  OT Complex 1st floor, KIMS Hospital block, Dept of Anaesthesiology GST Road, Chinna Kolambakkam
Kancheepuram
TAMIL NADU 
7373166684

varun.sambath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients posted for elective lower abdominal surgeries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Ibuprofen 400mg IV Inj. Paracetamol 1gram IV Inj. Tramadol 100mg IV  After taking informed consent, detailed history regarding the patients age, sex, occupation and course of the treatment. Study drugs will be administered intraoperatively 30 mins before the end of the surgery. The assessment of postoperative pain will be done using two different type of pain scales at 30 min, 4hrs, 8hrs,12 hrs,20 hrs and 24 hrs after surgery and the data will be recorded in both groups. If the pain scales show score of 4 or above the dose of the same combination will be repeated at that time and the frequency between the doses will also be noted for both the groups Group allotment will be done by random lot pick method by subjects from a sealed envelope bag. Group A will receive 1g Paracetamol IV with 100mg Tramadol IV intraoperatively. Group B will receive 400mg Ibuprofen IV with 100mg Tramadol IV intraoperatively.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age from 18 to 60 years
Both male and females 
 
ExclusionCriteria 
Details  Failed Subarachnoid block
Know allergy to any of the study drugs
Hepatic and renal dysfunction
Lower segment Caesarean section
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS Score
Numerical rating scale
 
30 min, 4hrs, 8hrs,12 hrs,20 hrs and 24 hrs after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Side effects
Duration of pain relief
Time at which first rescue analgesic given 
 
Side effects
Duration of pain relief
Time at which first rescue analgesic given 
30 min, 4hrs, 8hrs,12 hrs,20 hrs & 24 hrs after surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/02/2025 
Date of Study Completion (India) 06/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/11/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [varun.sambath@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Postoperative pain management is a critical aspect of patient care aimed at alleviating discomfort and facilitating recovery after surgery. Effective pain management involves a multidisciplinary approach, combining pharmacological and non-pharmacological interventions. Analgesic medications, such as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen, are commonly used.
The choice of analgesics depends on factors such as the type and extent of surgery, patient preferences, and potential side effects. Balanced analgesia, which involves using multiple agents with different mechanisms of action, is often employed to optimize pain relief while minimizing adverse effects.
Non-pharmacological methods, including physical therapy, relaxation techniques, and patient education, complement drug therapy. Individualized pain management plans and regular assessment of pain levels contribute to enhancing postoperative recovery and patient satisfaction.
The relevance of this study lies in optimizing postoperative pain management, specifically for lower abdominal surgeries with subarachnoid block. The current state of knowledge indicates varying practices, and understanding the comparative efficacy of IV ibuprofen with tramadol and IV paracetamol with tramadol can contribute to refining treatment protocols.
The research question stems from a need for evidence-based approaches in pain management. Gaps in knowledge exist due to limited conclusive data on the comparative effectiveness of these analgesic combinations for this specific surgical context. This study aims to address this gap and provide valuable insights into selecting the most effective analgesic regimen.
This study is essential for improving clinical decision-making, tailoring analgesic strategies, and ultimately enhancing patient outcomes in a specific surgical population where pain management is crucial for recovery and overall well-being.

 
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