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A clinical trial to study the effects of three drugs,Tapentadol,Pregabalin, Solifenacin in reducing bladder irritation after urinary catheterisation in patients undergoing Renal stone removal surgery through skin incision

Evaluation of preoperative Tapentadol, Pregabalin and Solifenacin for catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomy : A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029594
Enrollment
160
Registered
2020-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

Intervention1: Tab.Tapentadol: 100mg once per oral one hour prior to surgery Intervention2: Tab.Pregabalin: 75mg once per oral one hour prior to surgery Intervention3: Tab.Solifenacin: 5mg once per o

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex Aged 18 â?? 60 years Patients of American Society of Anaesthesiologists grade I & II Scheduled for elective percutaneous nephrolithotomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: Age 60 years Patients of American Society of Anaesthesiologists grade III & IV History of significant cardiac diseases like previous MI, arrhythmias, high A V conduction blocks, uncontrolled hypertension, angina. History of chronic use of beta-blockers Sleep apnoea Significant liver dysfunction History of chronic opioid use, Patients with renal failure ( higher serum creatinine levels >=1.5mg%, urine 3 at night or >8 in 24 hours) / transurethral resection of prostate for benign prostatic hyperplasia Hypersensitivity to any of the study drugs

Design outcomes

Primary

MeasureTime frame
Effect of preoperative oral administration of tapentadol, pregabalin and solifenacin on the prevalence and severity of catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomyTimepoint: Severity of CRBD will be evaluated by a blinded assessor at intervals of 0, 1, 2, 4, 6, 12, 24 hours postoperatively on four point severity scale

Secondary

MeasureTime frame
NONETimepoint: NA

Countries

India

Contacts

Public ContactProf Sanjay agrawal

All India Institute of Medical Sciences Rishikesh

docagrawal72@yahoo.in9761712630

Outcome results

None listed

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