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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT02729935 |
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Date of registration:
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31/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Parecoxib for Treatment of Catheter Related Bladder Discomfort
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Scientific title:
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Efficacy and Tolerance of Parecoxib for Prevention of Catheter-related Bladder Discomfort in Patients Undergoing Catheterization After TURBT: A Prospective, Randomized, Placebo-controlled, Double-blind Study |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02729935 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Ali JENDOUBI |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Tunis El Manar |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult (>/=18)
2. Male or female
3. Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
4. Under spinal anesthesia
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Exclusion Criteria:
1. Patient who disagrees to participate this investigation
2. Patient with severe cardiovascular disease
3. Patient with small-sized foley catheter (less than 18 Fr.)
4. Patinets with bladder outflow obstruction
5. Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)
6. Patients with chronic renal failure
7. Patient with morbid obesity
8. Patient with medications for chronic pain
9. Patient with disturbance of the central nervous system
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: Parecoxib
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Drug: Placebo
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Primary Outcome(s)
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Reducing of Catheter related bladder discomfort symptoms
[Time Frame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours]
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Secondary Outcome(s)
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safety and tolerability of parecoxib
[Time Frame: During the first 24 hours]
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Severity of Pain at suprapubic area
[Time Frame: at postoperative 0, 1, 6 and 12 hours]
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Secondary ID(s)
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University Of Tunis El Manar
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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