Parecoxib for Treatment of Catheter Related Bladder Discomfort

University Tunis El Manar60 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Postoperative Pain

Interventions

ParecoxibDRUG

40 mg of intravenous parecoxib 30 min before surgery

PlaceboDRUG

An equal volume of saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Ali JENDOUBI

Tunis, Tunis Governorate, Tunisia

Outcomes

Primary Outcomes

Reducing of Catheter related bladder discomfort symptoms

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 postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours

Secondary Outcomes

Severity of Pain at suprapubic area

Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)

Time frame: at postoperative 0, 1, 6 and 12 hours

safety and tolerability of parecoxib

Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events

Time frame: During the first 24 hours

Data from ClinicalTrials.gov

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