| CTRI Number |
CTRI/2024/12/077804 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, intravenous paracetamol and
intravenous tramadol for postoperative pain in patients undergoing laparoscopic
cholecystectomy. |
|
Scientific Title of Study
|
A comparative study to evaluate the clinical efficacy of Intravenous Paracetamol versus
Intravenous Tramadol for postoperative pain in patients undergoing Laparoscopic
Cholecystectomy. A Double Blind Randomized Control 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 |
Akash Maurya |
| Designation |
PGJR |
| Affiliation |
Heritage Institute of Medical Sciences, Varanasi |
| Address |
Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P.
Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P.
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9454197832 |
| Fax |
|
| Email |
mauryaakash074@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akhilesh Mishra |
| Designation |
Professor |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P.
Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P.
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9582113920 |
| Fax |
|
| Email |
akhil61086@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akhilesh Mishra |
| Designation |
Professor |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P.
Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P.
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9582113920 |
| Fax |
|
| Email |
akhil61086@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute of Medical Sciences, Bhadwar,NH2 Bypass, Varanasi 221311, U.P. |
|
|
Primary Sponsor
|
| Name |
Heritage Institute of Medical Sciences |
| Address |
NH-2 Bypass,Bhadwar,Varanasi-221311 |
| 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 Akash Maurya |
Heritage Institute of Medical Sciences |
Department of Anaesthsiology, OT Complex,OT No.1 & 2, NH-2 Bypass,Bhadwar,Varanasi-221311
Varanasi
UTTAR PRADESH |
9454197832
mauryaakash074@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,Heritage Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of Intravenous Paracetamol for postoperative pain reduction. |
To evaluate the clinical efficacy of 1g Intravenous Paracetamol for postoperative pain in patients undergoing Laparoscopic Cholecystectomy, to check response to the drug in term of reduction of pain at different time points just before drug administration(T0), 30thminute(T1), 2ndhour(T2), 4thhour(T3), 8th hour(T4), 16thhour(T5) and 24thhour(T6) and asses its side effects. |
| Comparator Agent |
Administration of Intravenous Tramadol for postoperative pain reduction. |
To evaluate the clinical efficacy of 100mg Intravenous Tramadol for postoperative pain in patients undergoing Laparoscopic Cholecystectomy, to check response to the drug in term of reduction of pain at different time points just before drug administration(T0), 30thminute(T1), 2ndhour(T2), 4thhour(T3), 8th hour(T4), 16thhour(T5) and 24thhour(T6) and asses its side effects. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I/II patients,
Age between 18-60 years scheduled for elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients who had history of allergy to paracetamol or tramadol,
Patients with severe pain (VAS ≥ 5),
Patients with signiï¬cant coronary artery disease or ischemic myocardial disease,
Patients with renal disease , liver disease , chronic lung disease and haemorrhagic conditions and/or coagulopathies,
Patients with history of addiction to opioids or alcohol,
Patient’s refusal |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intravenous paracetamol provides better management in postoperative pain in patients undergoing laparoscopic cholecystectomy.
|
Pain score before drug administration (T0), 30th minute (T1), 2nd hour (T2), 4th hour (T3), 8th hour (T4), 16th hour (T5), 24th hour (T6).
Haemodynamic parameters at 0 minute, 30 minutes, 2 hr, 4 hr, 8 hr, 16 hr, 24 hr.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intravenous paracetamol has lesser side effects as compared to intravenous tramadol.
|
Haemodynamic parameters at 0 minute, 30 minutes, 2 hr, 4 hr, 8 hr, 16 hr, 24 hr.
Prevalence of Adverse effects – Nausea, Vomiting, Dizziness, Drowsiness |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="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 study is a Double Blind Randomized Control Trial to evaluate the clinical efficacy of Intravenous Paracetamol versus Intravenous Tramadol for post-operative pain in patients undergoing Laparoscopic Cholecystectomy. in this study we will evaluate response to the drugs in term of reduction of pain at different time points i.e. before drug administration(T0), at 30th minute(T1), at 2nd hour(T2), at 4th hour(T3), at 8th hour(T4), at 16th hour(T5) and at 24th hour(T6) and will also compare the adverse effects of Intravenous Paracetamol versus Intravenous Tramadol. |