| CTRI Number |
CTRI/2026/02/103879 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of bladder instillation of ropivacaine in reducing urinary catheter related bladder discomfort after transurethral urological surgery in adult patients. |
|
Scientific Title of Study
|
Evaluation Of The Efficacy Of Intravesical Ropivacaine In
Reducing Catheter Related Bladder Discomfort After
Transurethral Surgery – A Prospective Study |
| 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 Sandip Baheti |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Hospital and Research Centre |
| Address |
Dr Sandip Baheti
Professor,Department of anesthesiology
Dr DY Patil Medical College, Hospital and Research Centre
Sant tukaram nagar, Pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip Baheti |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Hospital and Research Centre |
| Address |
Dr Sandip Baheti
Professor,Department of anesthesiology
Dr DY Patil Medical College, Hospital and Research Centre
Sant tukaram nagar, Pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip Baheti |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Hospital and Research Centre |
| Address |
Dr Sandip Baheti
Professor,Department of anesthesiology
Dr DY Patil Medical College, Hospital and Research Centre
Sant tukaram nagar, Pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil Medical College Hospital and Research Centre |
| Address |
Dr DY Patil Medical College, Hospital and Research Centre
Sant tukaram nagar, Pimpri
Pune,Maharashtra 411018 |
| 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 Keerthana L |
Dr DY Patil Medical College, Hospital and Research Centre |
Department of anesthesiology,
Dr DY Patil Medical College, Hospital and Research Centre
Pimpri, Pune
Pune
MAHARASHTRA |
8073954392
dr.keerthana98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N210||Calculus in bladder, (2) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravesical normal saline 0.9 percent |
Patients will be assessed in post operative period for catheter related bladder discomfort(CRBD). When the patient complaints of mild to moderate pain according to CRBD grading, normal saline 0.9 percent will be instilled into the bladder through urinary catheter and clamped for 30 minutes |
| Intervention |
Intravesical Ropivacaine 0.5 percent |
Patients will be assessed in post operative period for catheter related bladder discomfort(CRBD). When the patient complaints of mild to moderate pain according to CRBD grading, ropivacaine 0.5 percent will be instilled into the bladder through urinary catheter and clamped for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patient
age more than 18 years
elective transurethral urological surgery (URSL, RIRS, cystolithotripsy)
hemodynamically stabl
routine investigations within normal limits
written informed consent obtained. |
|
| ExclusionCriteria |
| Details |
ASA III or higher
age more than 18 years
emergency procedures
uncontrolled systemic diseases
known allergy to study drugs
refusal to participate |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of catheter related bladder discomfort (CRBD) assessed using standardized CRBD grading scale following intravesical instillation. |
T0 – At onset of mild to moderate CRBD postoperatively T1 – At time of declamping T2 – 6 hours post declamping T3 – 12 hours post declamping T4 – 24 hours post declamping |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Postoperative pain intensity assessed using Visual Analogue Scale (VAS). 2. Requirement of rescue analgesia (paracetamol 1 g IV). 3. Incidence of local or systemic adverse effects related to ropivacaine instillation. 4. Patient satisfaction scores regarding urinary comfort & postoperative experience. 5. Hemodynamic parameters including heart rate, blood pressure, respiratory rate & oxygen saturation. |
at baseline,30 minutes, 6 hours,12 hours & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="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 primary purpose of this prospective randomized double blinded study is to evaluate the efficacy of intravesical ropivacaine in reducing the incidence and severity of catheter related bladder discomfort in patients undergoing transurethral urological surgery. Catheter related bladder discomfort is a common postoperative problem that causes significant patient discomfort and agitation. Intravesical administration of ropivacaine may provide targeted local analgesia by reducing detrusor overactivity and bladder mucosal irritation. The study hypothesis is that intravesical instillation of 0.5 percent ropivacaine will significantly reduce the incidence and severity of catheter related bladder discomfort, decrease postoperative pain scores and rescue analgesia requirement, and improve patient comfort compared to normal saline placebo without significant adverse effects. |