| CTRI Number |
CTRI/2023/06/054450 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intravenous vs Intraperitoneal use of Injection.Dexamethasone for pain management in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparing Intravenous vs Intraperitoneal Dexamethasone for Postoperative pain management- randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bikram Rout |
| Designation |
consultant |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
Department of General surgery ,Department of Gastro surgery ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,SIJUA,PATRAPADA,BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
surg_bikram@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikram Rout |
| Designation |
Consultant |
| Affiliation |
ALL INFDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
Department of General surgery
Department of Gastrosurgery
ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,SIJUA,PATRAPADA,BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
surg_bikram@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatachalam gari mounika |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
Department of General surgery Department of Gastro surgery ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,SIJUA,PATRAPADA,BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
v.mounika56@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS BHUBANESWAR |
| Address |
SIJUA PATRAPADA 751019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bikram Rout |
AIIMS, Bhubaneswar |
Department of General Surgery
Khordha
ORISSA |
8763278543
pinkurout82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
Intra peritoneal Inj Dexamethasone just after removing the Gallbladder |
| Intervention |
Dexamethasone |
Inj Dexamethasone Intravenous administration 1 hour before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All Diagnosed cases of symptomatic gall stone disease ,belonging to ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Previous history of steroid intake
2.Diabetic patients with uncontrolled sugars
3. previous history of prolonged intake of steroids
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain assesment with VAS |
1 hour 6 hours 12 hours 18 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VOMITING |
at 1 hour 6 hours 12 hours 18 hours 24 hours |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 3 |
|
Date of First Enrollment (India)
|
09/07/2023 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
MY TRIAL IS REGARDING POSTOPERATIVE PAIN REDUCTION WITH DEXAMETHASONE TO TEST IF THE ROUTE OF ADMINISTRATION AND TIMING WOULD IMPACT THE OUTCOME
|