The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
Primary Purpose
Bladder Cancer, Benign Prostate Hyperplasia, Hematuria
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Diclofenac Sodium
Cystoscopy
Lubricant Gel
Sponsored by
About this trial
This is an interventional supportive care trial for Bladder Cancer
Eligibility Criteria
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
Sites / Locations
- Medeniyet UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Diclofenac group
Placebo
Arm Description
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03831321
Brief Title
The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
Official Title
The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
April 22, 2019 (Anticipated)
Study Completion Date
May 22, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taha Uçar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Benign Prostate Hyperplasia, Hematuria, Pain, Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Double blind placebo controlled
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac group
Arm Type
Active Comparator
Arm Description
The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cystoscopy
Intervention Description
Diagnostic cystoscopy
Intervention Type
Drug
Intervention Name(s)
Lubricant Gel
Intervention Description
To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)
Primary Outcome Measure Information:
Title
Assesment for operational pain
Description
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.
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Assesment of doctors comfort for the procedure(cystoscopy)
Description
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.
Time Frame
1 minute
Title
Assesment of qualification of cystoscopy
Description
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".
Time Frame
1 minute
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taha Uçar
Phone
05353044736
Email
ucartaha@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asıf Yıldırım
Organizational Affiliation
Medeniyet University
Official's Role
Study Director
Facility Information:
Facility Name
Medeniyet University
City
Istanbul
State/Province
Outside U.S./Canada
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taha Uçar
Phone
5353044736
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
We'll reach out to this number within 24 hrs