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CTRI Number  CTRI/2025/06/088234 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two drugs in reducing catheter related bladder discomfort among patients undergoing bladder surgeries 
Scientific Title of Study   Transurethral lidocaine irrigation compared to oral Solifenacin prophylaxis for postoperative catheter related bladder discomfort in transurethral resection surgeries: A randomised non inferiority 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  Keerthana B 
Designation  Junior Resident 
Affiliation  PGIMER CHANDIGARH 
Address  4th floor, Department of Anaesthesia and Intensive Care, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9791978091  
Fax    
Email  keerthanabalachandiran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajay Singh 
Designation  Associate Professor 
Affiliation  PGIMER CHANDIGARH 
Address  4th floor, Department of Anaesthesia and Intensive Care, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9999276845  
Fax    
Email  ajay.ydv2509@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajay Singh 
Designation  Associate Professor 
Affiliation  PGIMER CHANDIGARH 
Address  4th floor, Department of Anaesthesia and Intensive Care, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9999276845  
Fax    
Email  ajay.ydv2509@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, Chandigarh, India 
 
Primary Sponsor  
Name  PGIMER, Chandigarh, India 
Address  Sector 12, Chandigarh, 160012, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
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 B  Post Graduate Institute of Medical Education & Research, Chandigarh   Urology OT, 4th floor OT complex, Nehru hospital, PGIMER, Sector 12, Chandigarh, India
Chandigarh
CHANDIGARH 
9791978091

keerthanabalachandiran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Post Graduate Institute of Medical Education & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Solifenacin  Group S will receive oral Solifenacin 5 mg 2 hours prior to the surgery and will receive only normal saline bladder irrigation at the end of surgery  
Intervention  Transurethral Lignocaine  Patient in Group L will receive transurethral bladder irrigation of normal saline with 0.02% lidocaine at the end of surgery with a contact time of 10 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age 18-65 years

2.ASA-PS I/II

3.Patients undergoing elective TURBT surgeries under general anesthesia
 
 
ExclusionCriteria 
Details  1. Patient Refusal to give consent for the study
2.ASA –PS more than 2
3.Patients who are known cases of arrhythmias,
heart block, atrial fibrillation or any cardiac dysfunction
4.Severe respiratory diseases
5.Cirrhosis of the liver
6.History of urinary catheter in situ
7.Allergy to lidocaine
8.Allergy to solifenacin
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence and severity of CRBD in patients receiving transurethral lidocaine irrigation compared to those receiving oral Solifenacin prophylaxis and to demonstrate non-inferiority.  From start of the surgery to 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
The assessment of following factors during post operative period
1.Patient satisfaction score (7-point Global Perceived Effects Scale)

2.NRS for pain score at 0,1,2,6 and 24 hours after surgery.

3.QoR-15 score at 24 hours

4.Rescue analgesia requirement
 
From 0 to 24 hours post surgery 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/06/2025 
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 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  
After approval from the Institute Ethics Committee, PGIMER, Chandigarh, written informed consent will be obtained from all patients before enrollment in this randomised controlled study.
All patients will undergo standard pre-anaesthetic exam. The patients who meet the inclusion criteria will be included in the study.
The procedure will be explained and consent will be taken.
92 patients will be randomly divided into group L (Lidocaine) or group S (Solifenacin) in a 1:1 ratio using a computer-generated list concealed by sealed opaque envelopes. 
Fasting of the patients will be confirmed
After randomization the patients who are assigned to Group S will receive oral Solifenacin 5 mg 2 hours prior to the surgery and Group L will receive oral placebo.
Once the patient enters the operating room, ASA standard monitors will be attached, a warming device will also be attached. IV access will be  taken and the patient will receive intravenous fluid
Baseline vitals (HR, SpO2, SBP, DBP, MAP) will be recorded.
General anesthesia will be given following standard protocol with IV Fentanyl (2mcgs/kg), and IV Propofol(1-2.5mg/kg) with or without muscle relaxation (requirement based on tumor location).
The airway will be secured by an appropriate size Supraglottic airway device or Endotracheal tube at the discretion of the treating anesthesiologist.
Patient in Group L will receive transurethral bladder irrigation of normal saline with 0.02% lidocaine at the end of surgery with a contact time of 10 minutes, and their Foley’s balloon will be inflated with 2% lignocaine 10ml
Patients in Group S will receive normal saline bladder irrigation at the end of surgery and their Foley’s balloon will be inflated with 10 ml normal saline
At the end of surgery, the neuromuscular blocking agent will be antagonized with a combination of neostigmine 0.05 mg/ kg and glycopyrrolate 0.01 mg/kg
Patients will be extubated and transferred to PACU once they are fully conscious and maintaining adequate spontaneous ventilation.
 Post surgery an assessment of CRBD severity will be done upon receiving the patient in the postoperative care unit (PACU) at 0,1, 2, 6, and 24 hours post-surgery.
 24-hour postoperative QoR-15 score will be assessed
 Patient satisfaction score, Numerical Rating Scale (NRS) pain score, and use of rescue analgesia will be assessed at the PACU.
 

 
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