| CTRI Number |
CTRI/2025/08/092396 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison of three drugs for pain relief after laparoscopic surgery |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Paracetamol, Diclofenac And Dexamethasone For Post Operative Analgesia In Laparoscopic Surgeries - A Prospective Double-Blinded 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 Shirley Stephen |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi Institute of Medical Sciences Adilabad |
| Address |
Department of Anaesthesiology Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana 504001 Adilabad TELANGANA 504001 India
Adilabad
TELANGANA
504001
India
Adilabad
TELANGANA
504001
India |
| Phone |
9488651342 |
| Fax |
|
| Email |
shirley81@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Stephen |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi Institute of Medical Sciences Adilabad |
| Address |
Department of Anaesthesiology Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana 504001 Adilabad TELANGANA 504001 India
Adilabad
TELANGANA
504001
India
Adilabad
TELANGANA
504001
India |
| Phone |
9488651342 |
| Fax |
|
| Email |
shirley81@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Stephen |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi Institute of Medical Sciences Adilabad |
| Address |
Department of Anaesthesiology Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana 504001 Adilabad TELANGANA 504001 India
Adilabad
TELANGANA
504001
India
Adilabad
TELANGANA
504001
India |
| Phone |
9488651342 |
| Fax |
|
| Email |
shirley81@rediff.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Institute of Medical Sciences Adilabad |
| Address |
Rajiv Gandhi Institute of Medical Sciences RIMS Rickshaw colony Adilabad Telangana 504001 |
| 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 Shirley Stephen |
Rajiv Gandhi Institute of Medical Sciences Adilabad |
Department of Anesthesiology, Operation theatre complex, Second floor, Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana
Adilabad
TELANGANA 504001
Adilabad
TELANGANA |
9488651342
shirley81@rediff.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana |
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 |
group A Opioids |
Fentanyl 100 mcg iv single stat dose for induction Morphine 0.1mg/kg iv single stat dose 1 hour after induction |
| Comparator Agent |
group B Paracetamol |
Paracetamol 1gm IV single dose over 10 minutes after induction |
| Comparator Agent |
group C Diclofenac |
Diclofenac 75mg IV single stat dose 10 minutes after induction |
| Comparator Agent |
Group D Dexamethasone |
Dexamethasone 8mg single stat dose iv 10 minutes after induction |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA 1 and 2,
Elective laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
cardiac diseases IHD CAD
respiratory diseases COPD ILD Asthma
neuropsychiatric disorders
Obese patients Obstructive sleep apnea
Difficult airway and intubation
pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain scores, Intra operative Opioid requirements and Duration of Analgesia in the Post operative period |
EVERY 5MIN FOR 1 HOUR, THEN EVERY HOUR FOR 4 HRS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation scores at end of surgery, PONV episodes |
6hours and 12 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
|