| CTRI Number |
CTRI/2024/08/072047 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Washing of bladder with local anesthetic after removal of bladder tumor for reduction of bladder discomfort. |
|
Scientific Title of Study
|
Transurethral Ropivacaine (100mg) bladder irrigation reduces the incidence of bladder discomfort in transurethral resection of bladder tumor. |
| 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 Rajeev Ranjan |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Science,BHU, Varanasi |
| Address |
Department of Anesthesiology, Institute of Medical Science,Banaras Hindu University , Varanasi, Uttar Pradesh,221005 , India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8004308185 |
| Fax |
|
| Email |
r8004308185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Science, BHU, Varanasi |
| Address |
Department of Anesthesiology, Institute of Medical Science,Banaras Hindu University , Varanasi, Uttar Pradesh,221005 , India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317010317 |
| Fax |
|
| Email |
atulksingh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Science, BHU, Varanasi |
| Address |
Department of Anesthesiology, Institute of Medical Science,Banaras Hindu University , Varanasi, Uttar Pradesh,221005 , India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317010317 |
| Fax |
|
| Email |
atulksingh84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005 , Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science |
| Address |
Banaras Hindu University, Varanasi, Uttar Pradesh,221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajeev Ranjan |
Sir Sunderlal Hospital |
Urology OT-Complex, 6th floor, Centenary Super Speciality Block, Department of Anesthesiology, Sir Sundarlal Hospital, Institute Of Medical Sciences , Banaras Hindu University, Varanasi,221005
Varanasi
UTTAR PRADESH |
8004308185
r8004308185@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University, Institute Of Medical Sciences_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 |
0.9% Normal Saline 500 ml |
0.9% Normal Saline will be used for washing the bladder after transurethral resection of bladder tumor. |
| Intervention |
Bladder wash with Ropivacaine 100mg |
Ropivacaine 100mg will be used for washing the bladder through urinary catheter after transurethral resection of bladder tumor to reduce the post-op bladder discomfort. Post-op pain was assessed every hourly for 6 hours. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Those undergoing transurethral resection of bladder tumor patients belonging to ASA physical status type 1&2. |
|
| ExclusionCriteria |
| Details |
Patients refusal
Age less than 35 years and more than 75 years
Patients having Coronary Artery Disease Hemodynamic unstability
Cardiac Conduction Defect
Coronary Artery Disease
Morbid Obesity
Allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the effect of Ropivacaine on reduction of irritative symptoms in transurethral resection of bladder tumor |
Baseline when drug will be used
At every 15 minute for 1st hour.
At every 30 minute for 2nd and 3rd hour.
At every hour for 5 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know duration of hospital stay
To know duration of significant hematuria and post-op bladder irrigation duration |
After 2 days of surgery
After 7 days of surgery |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="0"
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
|
We want to conduct a Case Control study to know the effect of Ropivacaine (100mg) to reduce the bladder discomfort happening post-operatively after Transurethral resection of bladder tumor . In case , 81 patients’ bladder shall be irrigated with Inj. Ropivacaine 100mg in 500 ml Normal Saline at the end of surgery over 10-15 mins while In Control ,81 Patients shall be irrigated with 0.9% Normal Saline without Inj Ropivacaine . Thereafter patients will be asked to answer a set of Questionnaire regarding bladder discomfort and other urinary symptoms at interval of one hour for 6 hours post surgery. At the end the responses of all the patients in Case and Control sets will be evaluated to depict the significance of Inj. Ropivacaine 100mg in mitigating the bladder discomfort in such patients |