| CTRI Number |
CTRI/2021/09/036432 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
14/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tapentadol nasal spray- a better alternative than intavenous tramadol and diclofenac |
|
Scientific Title of Study
|
Tapentadol nasal spray:a better alternative than conventional nsaids and opioids? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishith M Paul Ekka |
| Designation |
Assistant professor |
| Affiliation |
RIMS RANCHI |
| Address |
Department of general surgery, RIMS, Bariyatu Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
|
| Fax |
|
| Email |
drnmpekka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishith Paul Ekka |
| Designation |
Assistant professor |
| Affiliation |
RIMS RANCHI |
| Address |
Department of general surgery, RIMS, Bariyatu Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
|
| Fax |
|
| Email |
drnmpekka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishith M Paul Ekka |
| Designation |
Assistant professor |
| Affiliation |
RIMS RANCHI |
| Address |
Department of general surgery, RIMS, Bariyatu Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
|
| Fax |
|
| Email |
drnmpekka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences Ranchi |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences Ranchi |
| Address |
bariyatu ranchi jharkhand |
| 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 Jiwesh Kumar |
Department of general surgery |
second floor, old hospital wing, RIMS, bariatu, Ranchi
Ranchi
JHARKHAND |
8936027292
jjiwesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous diclofenac and intravenous tramadol |
the 2 other groups i.e. group B and C with patients, will be getting i.v.tramadol, i.v. diclofenac respectively and measurement of pain relief recoreded on post-op day 1, 2 and 3 |
| Intervention |
Tapentadol nasal spray |
tapentadol nasal spray will be administered and measurement of pain relief in post-op day 1,2,3 |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
UNDERGOING ANY TYPE OF SURGICAL PROCEDURE |
|
| ExclusionCriteria |
| Details |
PATIENTS OPTING OUT OF STUDY OR HAVING SEVERE CARDIOVASCULAR OR RENAL RISK FACTORS |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN POST-SURGICAL PAIN |
REDUCTION IN POST-SURGICAL PAIN measured on day 1, 2 and 3 and overall satisfaction measured on goal attainment scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall satisfaction measured on goal attainment scale |
at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/09/2021 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In our study, we are going to compare different drugs and routes of drugs administration in post-surgical patients which nasal spray of tapentadol , intravenous tramadol and intravenous diclofenac(aquous). patients will be randomized in 3 groups and matched accordingly to remove selection biases. they will be observed regarding the pain intensity after surgery for next three consecutive days and results will be recorded on visual analog scale. before discharge , patient’s complete response will be evaluated on goal-attainment scale and results will be compared accordingly. |