| CTRI Number |
CTRI/2024/10/075240 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study of Oral Etoricoxib and Oral Diclofenac for Post-Operative Pain Management Following Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparison of effectiveness of pre operative administration of oral Etoricoxib and oral Diclofenac on post operative pain relief after laparoscopic cholecystectomy-Randomized, Controlled, Clinical 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 Avnish Kumar Pandey |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9972568089 |
| Fax |
|
| Email |
pandeyavnish786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof S K Mathur |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
|
| Email |
skmathurbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof S K Mathur |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
|
| Email |
skmathurbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences
Banaras Hindu University
Varanasi Uttar Pradesh India 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Avnish Kumar Pandey |
| Address |
Institute of Medical Sciences
Banaras Hindu University
Varanasi. 221005 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof S K Mathur |
Sir Sunderlal Hospital BHU |
Department of Anaesthesiology
Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
9450955143
skmathurbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BHU Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
pre operative administration of oral Etoricoxib and oral Diclofenac |
Etoricoxib 120mg given by oral route one group of participants and Diclofenac 100mg given by oral route to other group of participants two hours before surgery |
| Comparator Agent |
Tab Diclofenac 100mg |
Diclofenac 100mg(two tablets of 50mg) given by oral route 2 hours before surgery |
| Comparator Agent |
Tab Etoricoxib 120mg |
Etoricoxib 120mg(two tablets of 60mg) given by oral route
2 hours before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and ASA 2 patients
2.Patient scheduled for laparoscopic cholectectomy
3.Patient between 18 to 60 yrs of age of either sex
4.Written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Not giving consent to study
2.ASA grade 3 and 4
3.Pregnant or breastfeeding
4.History of gastrointestinal ulcer or peptic ulcer events
5.Allergy to study drugs
6.Systemic diseases affecting kidneys, liver, blood, or central nervous system
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A prospective randomized control trial to compare the efficacy of etoricoxib and diclofenac in the management of post operative pain following laparoscopic cholecystectomy |
primary outcome will be the extent of pain. The intensity of the pain variable will be recorded using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). Each patient will be asked to rate the perceived pain at 1,2,3,4,5, 6, 8, 10,12 and 24 hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the time needed for first rescue analgesia (IV Tramadol).
2.To compare adverse effects between groups
3.To compare total rescue analgesia dose needed between groups in post operative period
|
assessment done at 1,2,3,4,5, 6, 8, 10,12 and 24 hour post operatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/10/2024 |
| 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="4"
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
|
This study is a Double blinded prospective randomized controlled trial Comparing the effectiveness of pre operative administration of oral Etoricoxib 120mg and oral Diclofenac 100mg two hours before surgery on post operative pain relief after laparoscopic cholecystectomy and will be carried out in the Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi. The primary outcome will measures the extent of pain. The intensity of the pain variable will be recorded using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). Each patient will be asked to rate the perceived pain at 1,2,3,4,5, 6, 8, 10,12 and 24 hour post operatively. The secondary outcomes will observe the time needed for first rescue analgesia (IV Tramadol),compare adverse effects between groups and compare total rescue analgesia dose needed between groups in post operative period .
|