| CTRI Number |
CTRI/2025/12/099594 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study of two medicines IV paracetamol and IV tramadol for pain after laparoscopic gallbladder surgery |
|
Scientific Title of Study
|
Comparative study of intravenous paracetamol and intravenous tramadol for post operative analgesia in laparoscopic cholecystectomy |
| 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 Prachi Thakur |
| Designation |
1st year PG |
| Affiliation |
PCMS and RC bhopal |
| Address |
Room No 2
3rd floor Department of General Surgery PCMS and RC
bhanpur bhopal
Peoples Hospital Bhanpur bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752405504 |
| Fax |
|
| Email |
prachithakur.vds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Garg |
| Designation |
Professor And Head of the Department of General Surgery |
| Affiliation |
Peoples hospital bhanpur Bhopal |
| Address |
Room no 2 Third floor Department of General Surgery People’s Hospital bhanpur Bhopal Madhyapradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9303235020 |
| Fax |
|
| Email |
Drnitin75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Garg |
| Designation |
Professor And Head of the Department of General Surgery |
| Affiliation |
Peoples hospital bhanpur Bhopal |
| Address |
Room no 2 Third floor Department of General Surgery People’s Hospital bhanpur Bhopal Madhyapradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9303235020 |
| Fax |
|
| Email |
Drnitin75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
People’s college of medical sciences and research centre Ayodhya bypass road Bhanpur Bhopal Madhya Pradesh India 462037 |
| 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 |
| Prachi Thakur |
Peoples Hospital |
Room no 2
3rd floor
Department of General Surgery
PCMS and RC Bhopal
Bhopal
MADHYA PRADESH |
9752405504
prachithakur.vds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples college of medical sciences and research centre bypass road bhanpur bhopal 462037 MP Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intavenous Tramadol |
100mg of Tramadol diluted in 100 ml of Normal Saline given 8 hourly in three doses |
| Intervention |
Intravenous Paracetamol |
100 ml infusion containing 1 gram Paracetamol given 8 hourly in three doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA physical states stage one and Two
BMI less than 40 kg per meter square
Patients posted for elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Emergency Cholecystectomy
If the surgery required conversion to open Cholecystectomy
Known hypersensitivity to paracetamol and tramadol
Daily intake of analgesics or steroids within two weeks surgery
Pregnant women and Lactating women
Patients with ASA physical states stages greater than 2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain score measured using the Visual Analogue Score 0 to 10 at 0hr 8th hr 16th hr and 24 th hr after laparoscopic cholecystectomy |
Every 8 hour upto 24 hours of post operative laparoscopic cholecystectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of times rescue analgesia was required within 24 hours & incidence of adverse effects using iv paracetamol & iv tramadol |
0 to 24hours post surgery continuous |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/01/2026 |
| 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 Applicable |
| 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
|
The prospective study will be conducted from 1st Sept 2025 to 28th Feb 2027 after approval from the Institutional Ethics Committee Informed written consent will be obtained from every participant in the study Adult patients between 18 to 55 years of age ASA I or ASA II who will be scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled Patients will be receiving analgesic as per prescription of the operating surgeon and investigator will not be deciding the analgesic Investigator will only observe the results once analgesic is used The patients will be divided into two groups Group A Patients who will receive intravenous Paracetamol 1g in 100 ml solution Group B Patients who will receive intravenous Tramadol 100 mg in 100 ml NS After surgery, initial dose of analgesic either Tramadol 100 mg intravenous or Paracetamol 1g intravenous will be given ondemand to the patients in the postoperative period Thereafter Tramadol 100 mg or Paracetamol 1g intravenous infusion will be given at 8 th 16 and 24 hours Pain intensity will be measured based on a 10 point Visual Analogue Scale VAS 0 to 10 cm 0 no pain and 10 worst imaginable pain VAS pain scores will be obtained postoperatively at just after the operation T0 before analgesic administration and 30 minute after the administration of intravenous paracetamol or intravenous tramadol at 8hour T1 and T2 16th hour T3 and T4 and 24 hour T5 and T6 duration Any pain score above 5 on VAS will be considered a breakthrough pain It will be managed by rescue analgesia with intravenous Diclofenac sodium 1.5 mg per kg in 100 ml NS repeated as required Observe and to be noted any adverse events of nausea vomiting and pain at intravenous site with intravenous paracetamol and intravenous tramadol Collection of all data will be done in EXCEL SHEET and then will be analyzed using SPSS software |