| CTRI Number |
CTRI/2024/03/064526 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Pain Relief Between Paracetamol and Ibuprofen before starting the surgery |
|
Scientific Title of Study
|
Comparison of the Efficacy of Preemptive Intravenous Ibuprofen over Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy under General Anesthesia - A Randomized Control 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. Preethi. V |
| Designation |
DNB Resident |
| Affiliation |
Narayana Hrudayalaya Limited |
| Address |
Room No. 42, Anaesthesia Clinic, Department of Anaesthesia, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9597300917 |
| Fax |
|
| Email |
drpreethivijayakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. Indumathi. T |
| Designation |
Consultant |
| Affiliation |
Narayana Hrudayalaya Limited |
| Address |
Room No. 42, Anaesthesia Clinic, Department of Anaesthesia , Mazumdar Shaw Medical Center , Narayana Health City , Bommasandra
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9538533850 |
| Fax |
|
| Email |
indumathisam@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR. Preethi. V |
| Designation |
DNB Resident |
| Affiliation |
Narayana Hrudayalaya Limited |
| Address |
Room No 42, Anaesthesia Clinic, Department of anaesthesia, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9597300917 |
| Fax |
|
| Email |
drpreethivijayakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya Limited,Narayana Health City, Bommasandra industrial area, Bengaluru - 560099 |
|
|
Primary Sponsor
|
| Name |
DR Preethi V |
| Address |
No. 42, Anaesthesia Clinic, Department of anaesthesia, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra, Bengaluru - 560099 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Preethi V |
Mazumdar Shaw Medical Center |
Room No. 42,Department of anaesthesia, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra, Bengaluru - 560099
Bangalore Rural
KARNATAKA |
9597300917
drpreethivijayakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NARAYANA HEALTH ACADEMIC ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ibuprofen |
400mg INTRAVENOUS @10 minutes prior to induction |
| Comparator Agent |
paracetamol |
1gram intravenous 10 minutes prior to induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 AND 2
Patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rescue analgesic requirement |
Upto 6 hours postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale score between 2 groups |
1st 6 hours in postoperative period |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/04/2024 |
| 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="0"
Months="5"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a randomized control trial to compare the analgesic effects of preemptive ibuprofen over paracetamol inpatients undergoing laparoscopic cholecystectomy. 26 patients in each group will be recruited for the study. Group A patients will receive paracetamol 1g and group B will receive 400mg iv infusion 10 minutes prior to induction and 8th hourly for the 1st 24 postoperative period. first 6 hours VAS score and the time for 1st rescue analgesic requirement will be compared |