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
|
|
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
|
|
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. |