| CTRI Number |
CTRI/2025/03/083605 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of intravenous Acetaminophen, ketorolac and ibuprofen for the post operative analgesia after urological surgeries |
|
Scientific Title of Study
|
A comparative evaluation of intravenous Acetaminophen, ketorolac and ibuprofen for the post operative analgesia in the patients undergoing urological surgeries under balanced general anaesthesia- A randomised controlled trial |
| 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 Yashasvee Bhan |
| Designation |
Post graduate student |
| Affiliation |
Adesh hospital |
| Address |
Department of anaesthesiology and intensive care
AIMSR bucho bathinda
Bathinda
PUNJAB
151101
India |
| Phone |
|
| Fax |
|
| Email |
sonabhan12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MRIDUL M PANDITRAO |
| Designation |
Professor AND HEAD |
| Affiliation |
AIMSR, bathinda |
| Address |
Department of anaesthesiology and intensive care
AIMSR, bucho
Bathinda
PUNJAB
151101
India |
| Phone |
8699921884 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MRIDUL M PANDITRAO |
| Designation |
Professor AND HEAD |
| Affiliation |
AIMSR, bathinda |
| Address |
Department of anaesthesiology and intensive care
AIMSR, bucho, bathinda
Bathinda
PUNJAB
151101
India |
| Phone |
8699921884 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute of medical sciences and research, bucho, bathinda, india
Pincode-151101 |
|
|
Primary Sponsor
|
| Name |
AIMSR |
| Address |
Adesh institute of medical sciences and research,bathinda, India |
| 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 |
| Dr Yashasvee Bhan |
Adesh institute of medical sciences and research |
Ot complex, Department of anaesthesiology and intensive care,
Bathinda
PUNJAB |
9646496742
sonabhan12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Adesh university, bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection acetaminophen |
Acetaminophen iv drug is a commonly used non-opioid analgesic and antipyretic. Various studies have proven its efficacy in pain relief in various urological surgeries |
| Intervention |
Injection ibuprofen |
Ibuprofen iv formulations are yet to be explored.uptil now Ibuprofen has been used in various oral formulations but the iv formulations are supposed to be revolutionary. In this study we shall use the iv formulations which has almost same mechanism as oral but the efficiacy shall be compared with the commonly used nsaids |
| Comparator Agent |
Injection ketorolac |
Ketorolac is a versatile NSAID,effectively reduces the need for opioids when used with them, while also reducing the likelihood of side effects. It has also been proven to have great pain relief in patients undergoing surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) All Urological surgeries like RIRS , PCNL, Nephrectomy, ESWL etc
2) Under Balanced General Anaesthesia
|
|
| ExclusionCriteria |
| Details |
1)ASA grade - III/IV
2) Patients undergoing urological surgeries under spinal or epidural or sedation anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effect on post operative analgesia on administration of Inj Acetaminophen/ Ketorolac or Ibuprofen given intravenously in patients undergoing urological surgeries under Balanced General Anaesthesia . |
T0- Before Induction
T1- Immediately after shifting to post- operative recovery room(RR)
T2- After giving analgesia of assigned group.
T3- Every 15 mins for 2 hours in RR.
T4- Every 4 hours till 24 hours stay at the hospital.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out if any hemodynamic changes or side effects occur on administration of Intravenous Acetaminophen /Ketorolac or Ibuprofen in patients undergoing urological surgeries under Balanced General Anaesthesia. |
T0- Before Induction
T1- Immediately after shifting to post- operative recovery room.
T2- After giving analgesia of assigned group.
|
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/04/2025 |
| 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
|
Post operative pain is the most common complication of urological surgeries. Traditionally opioids were a mainstay for treatment of post operative pain. But nowadays, opioid free multimodal anaesthesia approach is being preferred. Nsaids play a vital role in that. Iv preparations of Acetaminophen and ketorolac have been well established to relieve pain in post operative period but the newly formed iv preparation of Ibuprofen has not been yet well studied. Therefore our study shall compare the post op analgesic effects of iv preparations of Acetaminophen, ketorolac and ibuprofen in patients undergoing urological surgeries under BGA |