| CTRI Number |
CTRI/2025/08/092550 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative, prospective |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating pain relieving effectiveness and safety of injection paracetamol and injection diclofenac as post-operative pain management in patients undergoing
a surgery to remove the gallbladder using a minimally invasive approach. |
|
Scientific Title of Study
|
A comparative evaluation of analgesic efficacy
of intravenous paracetamol versus intravenous
diclofenac as post-operative pain management in
laparoscopic cholecystectomy- a prospective,
comparative clinical study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Jhatakia |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9825873000 |
| Fax |
|
| Email |
jhatakiaisha1697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760 India
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya,
Vadodara, Gujarat, India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodiya,Pipariya,Vadodara, Gujarat,India Pincode-391760 |
| Type of Sponsor |
Private 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 Chauhan |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Sumandeep Vidyapeeth, Waghodiya,Pipariya,Vadodara, Gujarat 391760, India
Vadodara
GUJARAT |
9099014672
drdinesh77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical 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 |
| Comparator Agent |
Intravenous injection of Diclofenac 2mg/kg |
Intravenous injection of Diclofenac 2mg/kg 15 minutes prior to ending of surgery. Post operative pain will be assessed by VAS score at 30 minutes, 4 hours, 8 hours, 12 hours, 24 hours. |
| Intervention |
Intravenous injection of Paracetamol 15mg/kg |
Intravenous injection of Paracetamol 15mg/kg 15 minutes prior to ending of surgery. Post operative pain will be assessed by VAS score at 30 minutes, 4 hours, 8 hours, 12 hours, 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to sign the written and informed consent.
Age group: 18-70 years.
Both male and female patients.
Patients posted for laparoscopic cholecystectomy under general anaesthesia with ASA-1 or ASA-2 grade. |
|
| ExclusionCriteria |
| Details |
Patient’s refusal from taking part in the study.
Special populations.
Pregnant and lactating women.
History of allergy to drugs.
Severe kidney and liver disease.
Patients with neuropathies or nerve injuries.
Patients with pain due to cause other than presenting disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic effect and safety profile of intravenous paracetamol v/s intravenous diclofenac in
post-operative pain management in laparoscopic cholecystectomy surgeries.
|
To study analgesic efficacy of intravenous paracetamol and intravenous diclofenac as post-operative pain management in laparoscopic cholecystectomy post-operatively at 30 minutes,4 hours, 8 hours, 12 hours, 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any intraoperative complications like nausea, vomiting, rigors, bradycardia, respiratory depression, hypotension. |
Hemodynamic parameters will be recorded at
2 minutes
5 minutes
10 minutes
20 minutes
30 minutes
45 minutes
60 minutes
75 minutes
90 minutes
105 minutes
120 minutes
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
25/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 to evaluate the analgesic efficacy of intravenous paracetamol and intravenous diclofenac as post-operative pain management in laparoscopic cholecystectomy in adult patients- A Comparative, Prospective, observational study to see which is superior in providing adequate post-operative analgesia safely without any adverse effects. |