Parecoxib for Treatment of Catheter Related Bladder Discomfort
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|ClinicalTrials.gov Identifier: NCT02729935|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Parecoxib Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery
40 mg of intravenous parecoxib 30 min before surgery
Other Name: DYNASTAT
Placebo Comparator: Placebo
An equal volume of saline
An equal volume of saline
Other Name: Saline
- Reducing of Catheter related bladder discomfort symptoms [ Time Frame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours ]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.
- Severity of Pain at suprapubic area [ Time Frame: at postoperative 0, 1, 6 and 12 hours ]Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)
- safety and tolerability of parecoxib [ Time Frame: During the first 24 hours ]Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729935
|Tunis, Tunisia, 1006|
|Principal Investigator:||Ali JENDOUBI||University Tunis El Manar|