Postoperative Pain
Conditions
Keywords
Parecoxib, Bladder Discomfort
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.
Interventions
DRUGParecoxib
40 mg of intravenous parecoxib 30 min before surgery
DRUGPlacebo
An equal volume of saline
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reducing of Catheter related bladder discomfort symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Pain at suprapubic area | 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 | During the first 24 hours | Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events |
Countries
Tunisia
Outcome results
None listed