| CTRI Number |
CTRI/2026/02/104616 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study compare effects of ondansetron added to bupivacaine for pain relief after laproscopic cholecystectomy surgery. |
|
Scientific Title of Study
|
Study to evaluate intraperitoneal role of ondansetron versus Dexamethasone as adjuvant with bupivacaine on post-operative analgesia. |
| 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 Ritu Baloda |
| Designation |
Associate Professor |
| Affiliation |
Pt.B D Sharma PGIMS ROHTAK |
| Address |
Department of Anaesthesiology pt. B D Sharma PGIMS Rohtak
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8427666673 |
| Fax |
|
| Email |
ritubaloda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Baloda |
| Designation |
Associate Professor |
| Affiliation |
Pt.B D Sharma PGIMS ROHTAK |
| Address |
Department of Anaesthesiology pt. B D Sharma PGIMS Rohtak
pt. B D Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8427666673 |
| Fax |
|
| Email |
ritubaloda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh |
| Designation |
Pg student |
| Affiliation |
Pt.B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology pt. B D Sharma PGIMS Rohtak
Pt.B d Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8901670630 |
| Fax |
|
| Email |
dinesh.dahiya12345@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology pt.B D Sharma PGIMS Rohtak 124001 |
| Type of Sponsor |
Government 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 Dinesh |
Postgraduate institute of medical sciences Rohtak |
Department of Anaesthesiology pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA |
8901670630
dinesh.dahiya12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraperitoneal instillation of 4mg Ondansetron (2ml) on gall bladder bed in patients undergoing Laparoscopic cholecystectomy |
Intraperitoneal instillation of 4mg ( 2ml) Ondansetron with 18ml Bupivacaine locally on gall bladder bed after removing gall bladder in patients undergoing Laparoscopic cholecystectomy |
| Comparator Agent |
Intraperitoneal instillation of 4mg(2ml) Dexamethasone gall bladder bed in patients undergoing Laparoscopic cholecystectomy |
Intraperitoneal instillation of 4mg ( 2ml) Dexamethasone on gall bladder bed in patients undergoing Laparoscopic cholecystectomy after removing gall bladder with 18ml Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 or 2 scheduled for elective Laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Refusal,pregnancy, open cholecystectomy, acute cholecystitis ,allergies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of VAS |
At baseline,1,2,4,6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess time to first rescue analgesia |
At baseline, 1,2,4,6 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)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
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
|
A Study to evaluate intraperitoneal role of ondansetron versus Dexamethasone as adjuvant with bupivacaine on post-operative analgesia on 60 patients ( 30 patients In each group) with ASA 1 or 2 undergoing elective Laparoscopic cholecystectomy under general anaesthesia an comparing VAS scores |