The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

Study Overview
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Brief Summary
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The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug. Parameters: Visual Pain Score during cystoscopy Cystoscopy comfort - a questionnaire to be filled by the doctor Excellent Very good Good Bad Too bad Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor. Post-Op: 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency 24th Hour dysuria, Frequency, A total of 144 patients, we plan to arrive at the end of 1 month.

Official Title
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The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

Conditions
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Pain, Bladder Cancer, Benign Prostate Hyperplasia, Hematuria, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: Diclofenac Sodium
* Device: Cystoscopy
* Drug: Lubricant Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accepted to participate 18-70 years old Men Exclusion Criteria: Previous peptic ulcer Gastro intestinal bleeding in advance Renal failure Liver failure Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug allergies 7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9- Patients who do not agree to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac group<br>The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local | Drug: Diclofenac Sodium<br>* 50 mg of diclofenac sodium will be administered to intervention group one hour before cystoscopy and lubricant gel with lidocaine will be administered to all patients just before cystoscopy.<br>Device: Cystoscopy<br>* Diagnostic cystoscopy<br>Drug: Lubricant Gel<br>* To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)<br>|
| Placebo Comparator: Placebo<br>The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy | Device: Cystoscopy<br>* Diagnostic cystoscopy<br>Drug: Lubricant Gel<br>* To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment for operational pain | All the patients will be assessed with Visual pain scale during cystoscopy procedure Scale is a well know pain assesment form which is ranged between 0 to 10 points and higher scores mean worse pain. | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment of doctors comfort for the procedure(cystoscopy) | It is subjective, It will made by a question which will be graded by the blind operator. The operator will choose one of the 5 answers. Scoring system will be range 1 to 5 and higher scores mean worse results. | 1 minute | 
| Assesment of qualification of cystoscopy | It is subjective. It will be made by a question which will be answered by blind operator. The operator will choose one of the answers which are adequate or not adequate. | 1 minute |