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

Taha Uçar

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Lubricant Gel; Drug: Diclofenac Sodium; Device: Cystoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03831321

MedeniyetUro

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

144 participants in 2 patient groups, including a placebo group

Diclofenac group

Active Comparator group

Description:

The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local

Treatment:

Device: Cystoscopy

Drug: Lubricant Gel

Drug: Diclofenac Sodium

Placebo

Placebo Comparator group

Description:

The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy

Treatment:

Device: Cystoscopy

Drug: Lubricant Gel