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Completed

NCT Number: NCT02729935

Parecoxib for Treatment of Catheter Related Bladder Discomfort

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ali JENDOUBI

Tunis, Tunis Governorate, 1006, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (>/=18)
  • Male or female
  • Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
  • Under spinal anesthesia
  • Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion criteria

  • Patient who disagrees to participate this investigation
  • Patient with severe cardiovascular disease
  • Patient with small-sized foley catheter (less than 18 Fr.)
  • Patinets with bladder outflow obstruction
  • Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)
  • Patients with chronic renal failure
  • Patient with morbid obesity
  • Patient with medications for chronic pain
  • Patient with disturbance of the central nervous system

Treatment and study plan

Parecoxib

Drug

40 mg of intravenous parecoxib 30 min before surgery

Other names: DYNASTAT

Placebo

Drug

An equal volume of saline

Other names: Saline

Primary outcomes

  1. Reducing of Catheter related bladder discomfort symptoms

    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.

Secondary outcomes

  1. Severity of Pain at suprapubic area

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

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

  2. safety and tolerability of parecoxib

    Time frame: During the first 24 hours

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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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