Ali JENDOUBI
Tunis, Tunis Governorate, 1006, Tunisia
NCT Number: NCT02729935
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).
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Tunis, Tunis Governorate, 1006, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40 mg of intravenous parecoxib 30 min before surgery
Other names: DYNASTAT
An equal volume of saline
Other names: Saline
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.
Time frame: at postoperative 0, 1, 6 and 12 hours
Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)
Time frame: During the first 24 hours
Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events
University Tunis El Manar
Other
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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