| CTRI Number |
CTRI/2022/10/046753 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
22/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TRAMADOL VERSUS TAPENTADOL POSTOPERATIVE PAIN MANAGEMENT |
|
Scientific Title of Study
|
COMPARISION OF SAFETY AND EFFICACY OF TRAMADOL VERSUS TAPENTADOL ON POST OPERATIVE PAIN MANAGEMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MURUGANAND M |
| Designation |
SENIOR RESIDENT |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL AND GI SURGERY,PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
PEELAMEDU
COIMBATORE
641001
INDIA
Coimbatore
TAMIL NADU
641001
India |
| Phone |
9443781645 |
| Fax |
|
| Email |
drmuruganandmylswami@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AATHIRA UDAYAKUMAR |
| Designation |
CLINICAL PHARMACIST |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL AND GI SURGERY,PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
PEELAMEDU
COIMBATORE
641001
INDIA
Coimbatore
TAMIL NADU
641001
India |
| Phone |
9442132340 |
| Fax |
|
| Email |
aathiranair.uk1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AATHIRA UDAYAKUMAR |
| Designation |
CLINICAL PHARMACIST |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL AND GI SURGERY,PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
PEELAMEDU
COIMBATORE
641001
INDIA
Coimbatore
TAMIL NADU
641001
India |
| Phone |
9442132340 |
| Fax |
|
| Email |
aathiranair.uk1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Institute of Medical Sciences And Research,Peelamedu,Coimbatore,Tamil Nadu-641001 |
|
|
Primary Sponsor
|
| Name |
Dr MURUGANAND M |
| Address |
DEPARTMENT OF GENERAL AND GI SURGERY,PEELAMEDU
COIMBATORE-641001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 MURUGANAND M |
DEPARTMENT OF GENERAL AND GI SURGERY |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
PEELAMEDU
COIMBATORE-641001
Coimbatore
TAMIL NADU |
9443781645
drmuruganandmylswami@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL HUMAN 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 |
| Comparator Agent |
C TRAMADOL |
C TRAMADOL 50 mg 1-0-1 ORAL for 4 days |
| Intervention |
T TAPENTADOL |
T TAPENTADOL 50 mg 1-0-1 ORAL for 4 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing open hernia surgeries |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Allergy to opiates
Renal failure(creatinine more than 2mg per dl
Respiratory allergy/asthma
Hepatic failure
Comorbid alcohol,opiod or other substance abuse disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of post operative pain using visual analogue score |
0,1,4,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of side effects |
1st,4th,12th and 24th hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/10/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized,double-blind study to compare the safety and efficacy of Tramadol Versus Tapentadol on post operative pain management.The primary outcome is Visual Analogue Score(VAS) at o,1,4,12,24 hours.The secondary outcome includes the incidence and severity of side effects at 1st,4th,12th and 24th hours. |