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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831321
• Other study ID #: MedeniyetUro
• Status: Recruiting
• Phase: Phase 4
• Start date: December 11, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: February 2019
• Source: Istanbul Medeniyet University
• Contact: Taha Uçar
• Phone: 05353044736
• Email: ucartaha[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. Visual Pain Score during cystoscopy

2. Cystoscopy comfort - a questionnaire to be filled by the doctor

1. Excellent

2. Very good

3. Good

4. Bad

5. Too bad

3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.

Post-Op:

1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency

2. 24th Hour dysuria, Frequency,

A total of 144 patients, we plan to arrive at the end of 1 month.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: May 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Accepted to participate

• 18-70 years old

• Men

Exclusion Criteria:

1. Previous peptic ulcer

2. Gastro intestinal bleeding in advance

3. Renal failure

4. Liver failure

5. 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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Bladder Cancer
• Hematuria
• Hyperplasia
• Lower Urinary Tract Symptoms
• Pain
• Prostatic Hyperplasia
• Urinary Bladder Neoplasms

Intervention

Drug:
• Diclofenac Sodium
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.

Device:
• Cystoscopy
Diagnostic cystoscopy

Drug:
• Lubricant Gel
To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)

Locations

Country	Name	City	State
Turkey	Medeniyet University	Istanbul	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
Taha Uçar

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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