Parecoxib for Treatment of Catheter Related Bladder Discomfort

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Parecoxib

• Registration Number: NCT02729935
• Lead Sponsor: University Tunis El Manar

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-16
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	An equal volume of saline
Parecoxib	Parecoxib	40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ali JENDOUBI; 🇹🇳 Tunis, Tunisia