| CTRI Number |
CTRI/2023/05/052968 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
The post operative analgesic effects of dexamethasone versus ondansetron as adjuvant to 0.25% bupivacaine bupivacaine via intraperitoneal infiltration in patients undergoing elective laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparative study of the analgesic efficacy of intraperitoneal instillation of dexamethasone versus ondansetron as adjuvants to bupivacaine 0.25% in patients undergoing elective laparoscopic cholecystectomy- A prospective randomised double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VINEETHA M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
304, NANDANA APARTMENTS, 902 1ST MAIN, LAKSHMIPURAM, MYSURU
DEPARTMENT OF ANAESTHESIA , 3RD FLOOR, JSS HOSPITAL, M G ROAD, MYSURU 570004
Mysore
KARNATAKA
570004
India |
| Phone |
9447940700 |
| Fax |
|
| Email |
vineetham92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VYSHNAVI S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA , JSS HOSPITAL, M.G. ROAD, MYSURU
JSS HOSPITAL, M G ROAD, MYSURU 570004
Mysore
KARNATAKA
570004
India |
| Phone |
9880110022 |
| Fax |
|
| Email |
vyshgiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VINEETHA M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
304, NANDANA APARTMENTS, 902 1ST MAIN, LAKSHMIPURAM, MYSURU
DEPARTMENT OF ANAESTHESIA, 3RD FLOOR, JSS HOSPITAL, M G ROAD, MYSURU 570004
Mysore
KARNATAKA
570004
India |
| Phone |
9447940700 |
| Fax |
|
| Email |
vineetham92@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS HOSPITAL, M.G.ROAD, MYSURU, 570004, KARNATAKA, INDIA |
|
|
Primary Sponsor
|
| Name |
JSS HOSPITAL |
| Address |
M.G.ROAD, MYSURU, 570004, KARNATAKA, INDIA |
| 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 VINEETHA M |
JSS MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA, 3RD FLOOR, JSS HOSPITAL, M.G.ROAD, MYSURU, 570004
Mysore
KARNATAKA |
9447940700
vineetham92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRAPERITONEAL INSTILLATION OF DRUGS |
INTRAPERITONEAL INSTILLATION OF 30 ML 0.25% BUPIVACAINE WITH 2 ML OR 8 MG DEXAMETHASONE OR 2ML OR 4MG ONDANSETRON AS ADJUVANTS ON THE GALL BLADDER BED AFTER REMOVAL OF THE GALL BLADDER |
| Comparator Agent |
INTRAPERITONEAL INSTILLATION OF DRUGS |
INTRAPERITONEAL INSTLLATION OF 30 ML 0.25% BUPIVACINE WITH 2 ML OR 8 MG DEXAMETHASONE OR 30 ML 0.25% BUPIVACAINE WITH 2 ML OR 4MG ONDANSETRON ON THE GALL BLADDER BED AFTER REMOVAL OF THE SPECIMEN |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II
Surgery duration up to or less than 2 hours |
|
| ExclusionCriteria |
| Details |
Patient using Steroids or NSAIDS
Patients with IHD/ Rhythm abnormalities.
Patients with significant hepatic, renal or hematological disorders.
Patients allergic to study drugs
Patients and his/her legally accepted representatives not willing to provide their voluntary written informed consent for participation in the study.
Surgery lasting for more than 2 hours
If the surgery gets converted to open cholecystectomy
Pregnant patients
Any patient with postoperative drain
Patients with BMI > 30
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in post operative pain in patients who have received 8mg dexamethasone than 4mg ondansetron via intraperitoneal infiltration |
IN A TIME PERIOD OF 24 HOURS POST SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in postoperative nausea and vomiting |
24 hours |
|
|
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 3 |
|
Date of First Enrollment (India)
|
29/05/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Asses for eligibility , patient will be selected based on the inclusion criteria, will be divided into three groups, Group D will receive 2ml 8mg dexamethasone, group O will receive 2ml of 4mg ondansetron and group c will receive 2ml normal saline along with 30ml 0,25% bupivacaine via intraperitoneal infiltration, general endotracheal anaestheisa will be administered to the patient and the surgery will be done, before extubation drugs will be infiltrated intraperitoneally by the general surgeon through the laparoscopic port over the gallbladder bed and diaphragmatic surface. after extubation postoperative monitoring will be done for pain and PONV, the effectiveness of the drug in reducing the incidence and severity of pain and PONV will be compared. |