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Comparing two drugs in reducing catheter related bladder discomfort among patients undergoing bladder surgeries

Transurethral lidocaine irrigation compared to oral Solifenacin prophylaxis for postoperative catheter related bladder discomfort in transurethral resection surgeries: A randomised non inferiority trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088234
Enrollment
92
Registered
2025-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 Con

Sponsors

PGIMER, Chandigarh, India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years 2.ASA-PS I/II 3.Patients undergoing elective TURBT surgeries under general anesthesia

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: From start of the surgery to 24 hours after surgery

Secondary

MeasureTime frame
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 Timepoint: From 0 to 24 hours post surgery

Countries

India

Contacts

Public ContactAjay Singh

PGIMER CHANDIGARH

ajay.ydv2509@gmail.com9999276845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026