| CTRI Number |
CTRI/2025/07/089911 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Study Comparing One-Time IV Ibuprofen and Paracetamol Before Surgery to Reduce Pain After Kidney Stone Removal" |
|
Scientific Title of Study
|
Analgesic efficacy of pre-emptive single dose intravenous ibuprofene versus paracetamol for postoperative pain management in percutaneous nephrolithotomy surgery. Aprospective comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyank Preyas |
| Designation |
1st year post graduate |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8700731422 |
| Fax |
|
| Email |
priyankpreyas837@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh rajkumar |
| Designation |
professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894723687 |
| Fax |
|
| Email |
bommidisrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Shanmugavalli |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of anaesthesia, 2nd floor, A BLOCK, Aarupadai veedu medical college and hospital, pondy cuddalore main roa, kirumampakkam bahour, kirumampakkam, puducherry, 607402 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Priyank Preyas |
Aarupadai Veedu Medical College and Hospital |
First Floor
A Block Department of Anesthesiology
Pondicherry
PONDICHERRY |
8700731422
priyankpreyas837@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Commitee aarupadai vedu medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
inj ibuprofen |
inj ibuprofen 400 miligram iv 30 minutes before the surgery |
| Comparator Agent |
Inj paracetamol |
inj paracetamol 1gram iv 30 minutes before the surgery |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
asa 1 2 and 3
undergoing pcnl
|
|
| ExclusionCriteria |
| Details |
known allergy to given drugs
patient with altered renal parameters
chronic liver disease
peptic ulcer disease
gastrointestinal disease
psychiatric illness
history of opioid and nsaids abuse |
|
|
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 comare the analgesic efficacy of pre emptive single dose intrAVENOUS IBUPROFEN AND PARACETAMOL assesing the total consumotion of opoidover 24 hours in post operative period between the groups |
to comare the analgesic efficacy of pre emptive single dose intrAVENOUS IBUPROFEN AND PARACETAMOL assesing the total consumotion of opoidover 24 hours in post operative period between the groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess pain using visual analogue scale over 24 hours between the groups
to study patient satisfacrtion score at 4 hour and 24 hour btween the groups
to study adverse effects over 24 hour between the groups
|
18 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| 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 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
|
it is a study comparing the analgesic efficacy of ibuprofen (400mg) and paracetamol(1 gram) when given pre emptively. further side effects of the drugs will also be studied. the drugs will be given 30 mins before the administration of general anesthesia. complications of the drugs during post operative period will be assessed upto 24 hours. patient satisfaction will also e assessed at 4 and 24 hours postoperatively. |