Parecoxib for Treatment of Catheter Related Bladder Discomfort

Study Overview
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Brief Summary
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Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).

Detailed Description
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Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline. Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.

Official 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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Parecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>/=18) Male or female Undergoing catheterization after transurethral resection of bladder tumor (TURBT) Under spinal anesthesia Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2. Exclusion Criteria: Patient who disagrees to participate this investigation Patient with severe cardiovascular disease Patient with small-sized foley catheter (less than 18 Fr.) Patinets with bladder outflow obstruction Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h) Patients with chronic renal failure Patient with morbid obesity Patient with medications for chronic pain Patient with disturbance of the central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parecoxib<br>40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery | Drug: Parecoxib<br>* 40 mg of intravenous parecoxib 30 min before surgery<br>* Other names: DYNASTAT;|
| Placebo Comparator: Placebo<br>An equal volume of saline | Drug: Placebo<br>* An equal volume of saline<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing of Catheter related bladder discomfort symptoms | CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours. | at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Pain at suprapubic area | Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam) | at postoperative 0, 1, 6 and 12 hours | 
| safety and tolerability of parecoxib | Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events | During the first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parecoxib, Bladder Discomfort