| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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
- 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).
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varun.sambath@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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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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