| CTRI Number |
CTRI/2024/12/077768 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
post operative pain management for patients undergoing Laparoscopic cholecystectomy, injection ketorolac vs injection ibuprofen |
|
Scientific Title of Study
|
Comparison of efficacy and safety profile
Of Injection Ibuprofen versus Injection Ketorolac as postoperative pain management in Laparoscopic cholecystectomy: A prospective, comparative, clinical 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 |
Jagrati Thadani |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7575070391 |
| Fax |
|
| Email |
drjagratithadani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| 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 Jagrati Thadani |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia
Department , General
Ot Complex, 2nd Floor,
Dhiraj Hospital , Smt.
Bhikiben Kanjibhai
Shah Medical Institute
and Research Centre ,
Wagodhia , Pipariya,
Vadodara. Pincode
391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
7575070391
drjagratithadani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, (2) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj ibuprofen |
inj ibuprofen 400mg i.v preoperatively over 30 mins,
followed by at the time of rescue analgesia, vas assessed for 24 hours and inj. ibuprofen given when was equal to or more than 4.
|
| Intervention |
injection ketrolac i.v |
inj ketrolac 30mg i.v preoperatively over 30 mins,
followed by at the time of rescue analgesia, vas assessed for 24 hours and inj. ketrolac given when was equal to or more than 4
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to sign informed consent.
ASA I, II and III patients undergoing general anaesthesia
No known history of allergy or h y p e r s e n s i t i v i t y to NSAID and study drugs . |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Allergy to study drugs.
Pregnant women.
Patient of chronic pain taking opioids or other pain medications.
Patient with history of drug abuse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare efficacy of inj. ibuprofen vs inj ketrolac |
baseline
at induction
extubation
at 2hous
at 4 hours
at 6hours
at 8 hours
at 12 hours
at 16 hours
at 20 hours
at 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare rescue analgesia for inj. ibuprofen vs inj. ketrolac |
baseline
at induction
extubation
at 2hous
at 4 hours
at 6hours
at 8 hours
at 12 hours
at 16 hours
at 20 hours
at 24 hours |
|
|
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)
|
15/12/2024 |
| 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="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
|
the purpose of this study is to compare the efficacy and safety profile of injection ibuprofen versus injection ketorolac in postoperative pain management in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia |