Clinical trial NCT02729935: Parecoxib for Treatment of Catheter Related Bladder Discomfort
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Parecoxib
Bladder Discomfort
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reducing of Catheter related bladder discomfort symptoms
timeFrame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
Secondary outcomes:
measure: Severity of Pain at suprapubic area
timeFrame: at postoperative 0, 1, 6 and 12 hours
measure: safety and tolerability of parecoxib
timeFrame: During the first 24 hours
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Ali JENDOUBI
Study officials:
affiliation: University Tunis El Manar
name: Ali JENDOUBI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jendoubi A, Aissi W, Abbes A, Bouzouita A, Fourati S, Necib H, Ghedira S, Houissa M. Efficacy and safety of Parecoxib for prevention of catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: Prospective randomised trial. Indian J Anaesth. 2018 Jun;62(6):461-465. doi: 10.4103/ija.IJA_137_18.